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Rehabilitation for balance dysfunction in patients after
stroke: a protocol of network meta-analysis
Journal: BMJ Open
Manuscript ID bmjopen-2018-026844
Article Type: Protocol
Date Submitted by the Author: 21-Sep-2018
Complete List of Authors: Li, Juan; CHENGDU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE , School of Health Cultivation and Rehabilitation Zhong, Dongling; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and Rehabilitation Ye, Jing; Chengdu University of Traditional Chinese Medicine, Acu-moxibustion and Tuina school He, Mingxing; Chengdu University of Traditional Chinese Medicine Liu, Xicen; Chengdu University of Traditional Chinese Medicine
Zheng, Hui Jin, Rongjiang; Chengdu University of Traditional Chinese Medicine Zhang, Shao-lan; Chengdu Medical College, Immunology teaching and research section
Keywords: balance dysfunction after stroke, Modern rehabilitations, Traditional Chinese medicine therapies, network meta-analysis, protocol
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Rehabilitation for balance dysfunction in patients after stroke: a
protocol of network meta-analysis
Juan Li1†, Dongling Zhong
1†, Jing Ye
2†, Mingxing He
1, Xicen Liu
1, Hui Zheng
2, Rongjiang
Jin1*, Shaolan Zhang
3*
1. School of Health Cultivation and Rehabilitation, Cheng Du University of Traditional
Chinese Medicine, Si Chuan, China
2. School of Acupuncture-Moxibustion and Tuina/The Third Affiliated Hospital, Cheng Du
University of Traditional Chinese Medicine, Si Chuan, China
3. Chengdu Medical College, Si Chuan, China
†Juan Li, Dongling Zhong and Jing Ye contributed equally to this work.
Emails of authors: [email protected]; [email protected]; [email protected];
[email protected]; [email protected]; [email protected];
*Corresponding authors: Professor Rongjiang Jin or Professor Shaolan Zhang, School of
Health Cultivation and Rehabilitation, Cheng Du University of Traditional Chinese
Medicine, Chengdu, 610075, China; Chengdu Medical College, Si Chuan, 610500, China.
E-mail: [email protected]; [email protected].
Abstract
Introduction
Multiple rehabilitation techniques have been reported to be effective for balance
dysfunction after stroke. However, the comparative effectiveness of these
rehabilitation techniques is still unclear. Therefore, the objective of this network
meta-analysis is to identify the most effective rehabilitation technique for balance
dysfunction after stroke.
Methods and analysis
The following databases will be searched: China Biology Medicine disc (CBM),
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China National Knowledge Internet (CNKI), Wan Fang Data, the Chinese Science
and Technology Periodical Database (VIP), Medline, EMBASE, Web of Science,
The Cochrane Library from inception to September 2018. All randomized controlled
trials (RCTs) utilized rehabilitations to treat the balance dysfunction in patients after
stroke will be included. The primary outcomes include the Berg balance scale (BBS),
the Fugl-Meyer Assessment (FMA) at the end of the treatment. The secondary
outcomes include the Barthel Index (BI), The Functional Ambulation Category Scale
(FAC), Fall rates, The Timed Up-and-go Test (TUGT), The MOS 36-item short-form
health survey (SF-36), and adverse events. In order to ensure that all relevant studies
will be included without personal biases, study selection, data extraction and quality
assessment will be performed independently by two reviewers. Assessment of risk of
bias will be performed using Review Manager V5.3 software and data synthesis will
be performed using WinBUGS 1.4.3 and R software.
Discussion
The findings of this network meta-analysis will summarize the direct and indirect
evidence of rehabilitations on balance dysfunction after stroke, it may also provide a
ranking of rehabilitation techniques for patients and therapists to choose the best
option.
Ethics and dissemination
The ethics approval is not required in network meta-analysis and the results will be
submitted to a peer review journal.
Trial registration number: PROSPERO (CRD 42018107441)
Strength and limitations of this study
� This study will be the first network meta-analysis to compare the effectiveness
and safety of different rehabilitation techniques for balance dysfunction after
stroke.
� The results of this study will provide evidence for the management of balance
dysfunction and help the therapists and patients to make decision.
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� In order to ensure that all relevant studies are included without personal biases,
study selection, data extraction and quality assessment will be performed
independently by two reviewers.
� Although the electronic search and hand search will be performed in this study,
potential unpublished trials are inevitable, which might introduce some bias. To
overcome this limitation, the experts in this field will be consulted for
unpublished trials.
� Owing to the difficulty of locating all the effective rehabilitation techniques for
balance dysfunction after stroke, we will review the guideline and consult the
experts for the recommended rehabilitation techniques.
Introduction
Stroke is a common clinical cerebrovascular disease, with a high morbidity, mortality,
and disability rates, which brings a heavy economic burden to society and families.
About 75% of patients after stroke have various degrees of impairment in the motor
system, sensory system, and activities of daily living (ADL)1. Stroke often leads to
reduction in muscle strength, muscle spasms, prosthetic sensory disorder, visual and
other impairments which affect the balance function of the patients. The completion
of most daily tasks depends on the normal balance function of the body, such as
standing, walking, and bathing. Balance dysfunction is one of the common daily
functional problems in stroke patients, which seriously affects the patient's daily life
and work. Patients after stroke have impaired standing and control of trunk posture,
which affects balance function2and daily lives, even worse, increases the risk of
falls3 4. In stroke patients, an increase in the risk of falls means lower quality of life
5.
Balance function is the ability to maintain the center of gravity within the limits of
base of support as in sitting, standing, walking or position transfering6. The control
of human balance is a comprehensive process relying on the integration of visual,
vestibular and somatosensory inputs in the central nerve system. One of the most
common problems encountered in patients with stroke is loss of balance which can
result in falls and serious injuries7. Falling is one of the most common complications
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in stroke rehabilitation process and can cause physical, psychological and
pathological changes8. It is likely to lead to recurrence of stroke and life-threatening
events9. Falls are more frequent in patients with stroke during hospitalization or
community rehabilitation. In the acute treatment period, there were 14% to 64.5% of
the elderly who had fallen, 24% to 47% in the rehabilitation phase, and 37.5% to 73%
of the cerebrovascular patients who returned to the community. Over 47% of elderly
patients with stroke in the community have fallen more than once10. Falling leads to
lengthen the hospital stay for the elderly, increase medical and nursing costs, and
cause economic losses directly or indirectly. The reports showed that China's annual
medical expenses caused by falls exceed 5 billion yuan, resulting in a direct or
indirect social cost of approximately 160 to 80 billion yuan11. Management of
balance dysfunction in patients with stroke plays a key role in fall prevention.
Numerous rehabilitation techniques have been used to treat balance dysfunction after
stroke, mainly caused by proprioception, visual impairment, vestibular dysfunction,
decreased central nervous system integration, decreased core muscle strength,
decreased muscle synergy, and cognitive dysfunction12. Modern rehabilitations like
proprioceptive neuromuscular facilitation (PNF)13 14, balance training instrument
(such as balance ball or balance board)15 16, visual feedback instrument
17, vestibular
rehabilitation therapy (VRT)18 19, neuromuscular training
20 and so on. Traditional
Chinese medicine therapies, including acupuncture, moxibustion, Chinese medicine,
Tuina, traditional Chinese exercises (TCEs)21 and so on. Rehabilitation techniques
for balance dysfunction after stoke mostly concentrate on increasing core muscle
strength and changing the center of gravity. TCEs like Tai Chi contains many
exercises of balance control, such as the weight of the body moved from one side to
the other, and between the single foot and the two feet22. Modern rehabilitations
usually increase balance dysfunction by creating an unbalanced plane, whether the
plane is virtual (using virtual reality technology) or realistic (using balance ball or
balance board).
With the development of evidence-based medicine, numerous systematic reviews
(SRs) have been conducted to investigate the effectiveness and safety of multiple
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rehabilitation techniques for balance dysfunction after stroke23-26. However, the
comparative effectiveness of these rehabilitation techniques is still unclear.
Unlike traditional pairwise meta-analysis, network meta-analysis is capable to
summarize the direct and indirect evidence and evaluate the relative efficacy of
multiple treatment comparisons. What is more, network meta-analysis is able to
provide the ranking of treatment options based on their effectiveness, which is
helpful for the doctors and patients to make the best choice of treatment.
Therefore, the purpose of this study is to compare different rehabilitation techniques
to determine their relative effectiveness and safety in the treatment of balance
dysfunction after stroke. We also aim to identify the most effective rehabilitation
technique for balance dysfunction after stroke.
2 Methods
2.1 Registration
The protocol of this network meta-analysis has been registered with the international
prospective register of systematic reviews (PROSPERO,
http://www.crd.york.ac.uk/PROSPERO). The registration number of this network
meta-analysis is CRD 42018107441. The protocol will be reported in accordance
with the guidelines of the Preferred Reporting Item for Systematic Review and
Meta-analysis Protocols (PRISMA-P).
2.2 Inclusion criteria
Type of studies
Only randomized controlled trials (RCTs) will be included. Trials without control
group or those with quasi-random allocation will be excluded. There are no
restrictions on language or publication date.
Type of participants
We will include RCTs that involved post-stoke patients which diagnosed according
to the stroke diagnostic criteria formulated by The Fourth National Cerebrovascular
Disease Conference in 199527, A Guide to the Prevention and Treatment of Chinese
Cerebrovascular Disease developed by the Chinese Medical Association in 200528,
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Standard for the Diagnosis and Evaluation of Stroke Difficulties formulated by the
Encephalopathy Emergency Team of the State Administration of Traditional Chinese
Medicine in 199629. There is no restriction on age, sex and race.
Type of interventions
Studies that used modern rehabilitation (such as proprioceptive neuromuscular
facilitation (PNF), balance training instrument (such as balance ball or balance
board), visual feedback instrument, vestibular rehabilitation therapy (VRT),
neuromuscular training ect.) or traditional Chinese medicine therapies (including
acupuncture, moxibustion, Chinese medicine, tuina, traditional Chinese exercise
(TCE) etc.) to treat patients with balance dysfunction after stoke.
Outcome measurements
In this network meta-analysis, all the following outcomes after the end of
interventions and after a follow-up time will be included.
Primary outcomes
The primary outcomes are the Berg balance scale (BBS) and the Fugl-Meyer
Assessment (FMA).
BBS assesses the functional postural abilities of patients in several conditions (lying
on the back, sitting, standing, leaning forward, change of position and so on). This
scale is composed of 14 items. The maximal score, reflecting the best functional
postural abilities, is 56 points30-32.
FMA as a method for assessing the balance was developed from the Brunnstrom
Level 6 functional grading (BRSS). This scale is composed of 7 items with 3 levels.
The maximal score is 14 points. Lower score, means more severe balance
dysfunction33.
Secondary outcomes
The secondary outcomes are the Barthel Index (BI), The Functional Ambulation
Category Scale (FAC), Fall rates, The Timed Up-and-go Test (TUGT), The MOS
36-item short-form health survey (SF-36), adverse events during the entire treatment
and follow-up period.
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BI, FAC, TUGT are outcomes for motor function; BI, SF-36 are outcomes for the
quality of life; Fall rates, adverse events during the entire treatment and follow-up
period are outcomes for the safety.
BI is used as standard measures for ADL and motor function34. FAC is an
assessment tool designed to categorize functional ambulation ability. TUGT is a
simple test used to assess a person's mobility and requires both static and dynamic
balance35.
2.3 Exclusion criteria
The following will be excluded: ①non-RCTs, cluster randomized trials, array
studies, reviews, case-control studies. ②balance dysfunction was not caused by
stroke, for example, caused by Parkinson’s disease, Pediatric cerebral palsy, knee
surgery or other diseases. ③duplicate or the data cannot be extracted. ④full text
cannot be obtained through various approaches.
2.4 Database and search
The following databases will be searched from inception to September 2018: China
Biology Medicine disc (CBM), China National Knowledge Internet (CNKI), Wan
Fang Data, the Chinese Science and Technology Periodical Database (VIP), Medline,
EMBASE, Web of Science, The Cochrane Library. And we will also search RCT
registration website, including http://www.ClinicalTrial.gov and
http://www.chictr.org.cn. A professional medical librarian (HZ) will design and
revise the search strategy. Relevant magazines and websites will be searched to
avoid missing eligible trials. Reference lists of identified publications will also be
manually searched. Experts in this field will be consulted for unpublished trials.
Search strategy please see appendixⅠ.
2.5 Studies selection
All the retrieved studies will be imported into Endnote(X8) and filtered the
duplicated studies. Two reviewers (DLZ and MXH) will screen the titles and
abstracts independently according to the inclusion and exclusion criteria then cross
check. Two reviewers (DLZ and MXH) will download the full text of all possibly
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relevant studies for further assessment independently then cross check. In case of
disagreements, two reviewers (DLZ and MXH) will resolve through team discussion
or a third reviewer (RJJ) will be involved.
2.6 Data extraction
A standardized data extraction form will be designed in advance. After identify all
the included studies, two reviewers (DLZ and MXH) will independently extract data,
which including study characteristics (author and published year), participant
characteristics (simple size, age, sex, disease course etc.), interventions (duration,
frequency, study period etc.), comparisons(duration, frequency, study period etc.),
outcomes (BBS, FMA, BI or SF-36) then the two reviewers (DLZ and MXH) will
cross check to make sure there is no misentry. In case of disagreements, two
reviewers (DLZ and MXH) will resolve through discussion or a third reviewer (SLZ)
will be involved.
2.8 Risk of bias assessment
The Cochrane risk of bias tool(www.cochrane-handbook.org.)36 will be used to
assess the risk of bias including the following items: random sequence generation,
allocation concealment, blind subjects, blind therapists and assessors, incomplete
outcome data, selective outcome reporting and other bias. If the study meets all
criteria will be categorized as low risk of bias; the trials with insufficient information
to judge will be categorized as unclear risk of bias; the trials meet none of the criteria
will be categorized as high risk of bias. Two reviewers (XCL and JL) will assess the
risk of bias independently then cross check to make sure no mistake. In case of
disagreements, two reviewers (XCL and JL) will resolve through discussion or a
third reviewer (RJJ) will be involved. Review Manager V5.3 software will be used to
make bias risk diagram.
2.9 Grading the quality of evidence
To help health professional make decisions regarding individual patients, we will
evaluate the quality of evidence for outcomes by using the
Grades of Recommendations, Assessment, Development and Evaluation (GRADE)
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system (http://www.gradeworkinggroup.org/society/index.htm). The GRADE includes
the following five aspects: limitations in study design, inconsistency, indirectness,
imprecision, and publication bias37. The quality of evidence will be graded as ‘high’,
‘moderate’, ‘low’ or ‘very low’ in accordance with the GRADE rating standards38.
The results of GRADE including evidence profile (EP) and summary of finding table
(SoF) will be generated using GRADE pro software.
2.10 Statistical analysis
Network meta-analysis
All the data for statistical analysis will be extracted in an excel file. The network
analysis will be used in the Bayesian framework using the Markov Chain Monte
Carlo (MCMC) algorithm. The node splitting will be performed to check
inconsistency when compare the indirect evidence with direct evidence. We will
adopt the deviance information criterion (DIC) to explore the model fitness, in which
the fixed and random effects model will be compared.
Since both primary outcomes and secondary outcomes are continuous data, the effect
size of the rehabilitation techniques will be calculated with the standardized mean
difference (SMD). If the trial present mean values of each time point, we will adjust
the outcomes by the baseline values. We will calculate the SMD directly for the trials
present the values of outcomes changing from baseline. The 95% credible interval
(CrI) of each SMD will also be calculated.
For each outcome, the rankogram plots and the surface under the cumulative ranking
curves (SUCRA) will be used to estimate the hierarchy of the different rehabilitation
techniques. A rankogram plots show the probabilities for rehabilitation techniques to
assume any of the possible rank. SUCRAs will be present as percentage. 100% for
the best treatment while 0% for the worst. Data analysis will be performed using
WinBUGS 1.4.3 and R software.
We will perform a narrative review and summarize the evidences, if the available
data are not suitable for synthesis.
Dealing with missing data
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If the extracted data is missing, the original authors will be contacted for more
information. If there are no reply from the original authors, we will try to calculate
the data through the available coefficients, the potential impact of these missing data
on the results of the systematic review will be examed in the sensitivity analysis.
Subgroup analysis
If significant heterogeneity between studies is found, we will search for the possible
causes from both clinical and methodological perspectives and provide an
explanation. Subgroup analysis and meta regression will be performed to explore
heterogeneity if sufficient comparable studies(≥ 10) are identified. Subgroup
analysis and meta regression will be performed based on age, sex, type of stroke,
disease course of stroke, the severity of balance dysfunction, the duration of
treatment. Also, the network meta regression will be conducted to explore the
possible sources of heterogeneity.
Sensitivity analysis
Sensitivity analysis of primary outcomes will be carried out to verify the robustness
of the study conclusions, assessing the impact of methodological quality, study
design, sample size and the effect of missing data as well as the analysis methods on
the result of this review.
Assessment of publication bias
For publication bias, each included study will be assessed according to the
CONSORT criterial; If the included studies is sufficient (≥10), funnel plot will be
generated to explore the potential for publication bias. If funnel plots are asymmetric,
we will try to interpret funnel plot asymmetry39.
3 Discussion
Balance dysfunction is one of the common daily functional problems in stroke
patients, which seriously affects the patient's daily life and work. Moreover, balance
dysfunction often leads to high fall rates, which brings great burden to stroke
patients, families and society. In addition, good balance function is the prerequisite
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for recovering the ability of independent walking.
Currently, multiple rehabilitation techniques have been reported to be effective for
balance dysfunction after stroke, such as acupuncture therapy40, robot-assisted
lower-limb rehabilitation41 and so on. Recent systematic reviews
42-44indicated that
modern rehabilitations and TCEs have beneficial effects on the balance function
among stroke patients. However, among the multiple rehabilitation techniques, the
comparative effectiveness of these rehabilitation techniques is still unclear.
Network meta-analysis is capable to summarize the direct and indirect evidence and
evaluate the relative efficacy of multiple treatment comparisons45. What is more,
network meta-analysis is able to provide the ranking of treatment options based on
their effectiveness.
Therefore, we will conduct this network meta-analysis aiming at assessing which
rehabilitation technique is the most effectiveness when compared with others. To this
purpose, this network systematic review aims at upgrading and improving the
rehabilitation of balance dysfunction by a complete analysis of all rehabilitation
techniques.
This is the first network meta-analysis to summarize the direct and indirect evidence
and compare the effects of different rehabilitation techniques in the management of
balance dysfunction after stroke. We hope that the finding of our study will provide
clinical recommendation for both therapists and patients with balance dysfunction
after stroke.
Ethics and dissemination
The ethics approval is not required in network meta-analysis. The results will be
reported in accordance with PRISMA. The findings will be submitted to peer review
journal or conference.
Contributors: RJJ and SLZ designed this systematic review. JL, DLZ and JY
draft the manuscript. The search strategy was developed by HZ. All authors
approved the publication of this protocol.
Funding: This work was financially funded by the National Natural Science
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Foundation of China (grant numbers 81674047 and 81704137).
Competing interests: None declared.
Data sharing statement: Not applicable.
Provenance and peer review: Not commissioned; externally peer reviewed.
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29. group SAoEec. Stroke Diagnosis and Curative Effect Evaluation Standard (Trial). Journal
of Beijing University of Traditional Chinese Medicine 1996,19(1):55-56.
30. Tyson SF DL. Reliability and validity of functional balance tests post stroke. Clin Rehabil
2004;18:916–23.
31. Yelnik A BI. Clinical tools for assessing balance disorders. Neurophysiol Clin
Neurophysiol 2008;38:439–445.
32. Blum L K-BN. Usefulness of the berg balance scale in stroke rehabilitation: a systematic
review. Phys Ther 2008;88:559–66.
33. AR F-M. Post strok heimplgia assessment of physical properties. Scand J Rehab Med
1980, 7: 85.
34. Mudaliar M R YSR, Tejashwani P P, et al. Quality of Life in Stroke Patients Using SSQoL
Scale and Barthel Index. Indian Journal of Pharmacy Practice:2018, 11(1):44-50.
35. Weng C S TZ, Min L I. The value of the timed “up and go” test at the evaluation of
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functional mobility in stroke patients. Chinese Journal of Rehabilitation Theory &
Practice:2004.
36. Higgins JP AD, Gøtzsche PC, et al. The Cochrane Collaboration's tool for assessing risk
of bias in randomised trials. BMJ 2011; 343: d5928.
37. Group GW. Grading quality of evidence and strength of recommendations. BMJ 2004,
328( 7454) : 1490.
38. Zeng Xiantao LW, Li Sheng, et al. How to understand and use the GRADE system
correctly. Chinese Journal of Evidence-based Medicine 2011, 11(9):985-990.
39. Sterne JA SA, Ioannidis JP, et al. Recommendations for examining and interpreting
funnel plot asymmetry in meta-analyses of randomized controlled trials. BMJ 2011
Jul 22;343:d4002.
40. H. Zheng WLL, H. ShangGuan, et al. Effect of acupuncture and moxibustion treatment on
limb motor dysfunction among stroke patients: meta-analysis. Chin J Rehabilitation
Med:31 (2) (2016) 217e221.
41. H. Li JMF, X.D. Gu, et al. The effects of robot-assisted lower-limb rehabilitation plus
psychological intervention on post-stroke depression. Chin J Phys Med
Rehabilitation:35 (8) (2013) 630e633.
42. B.L. Chen JBG, M.S. Liu, et al. Effect of traditional Chinese exercise on gait and balance
for stroke: a systematic review and meta-analysis. Plos One 10 (8)(2015) e0135932.
43. Ge L ZQX, Liao Y T, et al. Effects of traditional Chinese exercises on the rehabilitation of
limb function among stroke patients: A systematic review and meta-analysis.
Complementary Therapies in Clinical Practice:2017, 29:35.
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44. Li Z HX, Sheng J, et al. Virtual reality for improving balance in patients after stroke: A
systematic review and meta-analysis. Clinical Rehabilitation:2016, 30(5).
45. Lumley T. Network meta-analysis for indirect treatment comparisons. Statistics in
Medicine 2010;21(16):2313-24.
Figure 1 flowchart of network meta-analysis of rehabilitation for the balance dysfunction in
patients with stroke (Abbreviation: CBM: China Biology Medicine disc, CNKI: China National
Knowledge Internet, VIP: the Chinese Science and Technology Periodical Database)
Appendix N. Web of science search strategy.
number Search terms
1 Randomized controlled trial
2 Controlled clinical trial
3 Randomly
4 Randomized
5 Randomized
6 Trial
7 Or/1–6
8 Balance dysfunction after stroke
9 acupuncture
electroacupuncture
fire needle
body acupuncture
warm needle
auricular acupuncture
10 Tuina
Chinese tuina
Massage
Massage therapy
Chinese massage
Chinese manipulation
Chinese manipulative therapy
Chinese manipulation
11 Moxibustion
12 Chinese medicine
13 traditional Chinese exercises
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14 Proprioceptive neuromuscular facilitation
PNF
15 balance training instrument
balance ball
balance board
16 visual feedback instrument
17 vestibular rehabilitation therapy
VRT
18 neuromuscular training
19 Or/9–18
20 7 AND 8 AND 19
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flowchart of network meta-analysis of rehabilitation for the balance dysfunction in patients with stroke
210x297mm (200 x 200 DPI)
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Reporting checklist for protocol of a systematic review.
Based on the PRISMA-P guidelines.
Instructions to authors
Complete this checklist by entering the page numbers from your manuscript where readers will find
each of the items listed below.
Your article may not currently address all the items on the checklist. Please modify your text to
include the missing information. If you are certain that an item does not apply, please write "n/a" and
provide a short explanation.
Upload your completed checklist as an extra file when you submit to a journal.
In your methods section, say that you used the PRISMA-P reporting guidelines, and cite them as:
Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA. Preferred
Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement.
Syst Rev. 2015;4(1):1.
Reporting Item
Page
Number
Identification #1a Identify the report as a protocol of a systematic review 1
Update #1b If the protocol is for an update of a previous systematic
review, identify as such
-
#2 If registered, provide the name of the registry (such as
PROSPERO) and registration number
5
Contact #3a Provide name, institutional affiliation, e-mail address of all
protocol authors; provide physical mailing address of
corresponding author
1
Contribution #3b Describe contributions of protocol authors and identify the
guarantor of the review
1
#4 If the protocol represents an amendment of a previously
completed or published protocol, identify as such and list
changes; otherwise, state plan for documenting important
-
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protocol amendments
Sources #5a Indicate sources of financial or other support for the review 11
Sponsor #5b Provide name for the review funder and / or sponsor 11
Role of sponsor or
funder
#5c Describe roles of funder(s), sponsor(s), and / or institution(s),
if any, in developing the protocol
-
Rationale #6 Describe the rationale for the review in the context of what is
already known
3-5
Objectives #7 Provide an explicit statement of the question(s) the review will
address with reference to participants, interventions,
comparators, and outcomes (PICO)
5
Eligibility criteria #8 Specify the study characteristics (such as PICO, study design,
setting, time frame) and report characteristics (such as years
considered, language, publication status) to be used as
criteria for eligibility for the review
5-7
Information
sources
#9 Describe all intended information sources (such as electronic
databases, contact with study authors, trial registers or other
grey literature sources) with planned dates of coverage
7
Search strategy #10 Present draft of search strategy to be used for at least one
electronic database, including planned limits, such that it
could be repeated
15
Study records -
data management
#11a Describe the mechanism(s) that will be used to manage
records and data throughout the review
7-8
Study records -
selection process
#11b State the process that will be used for selecting studies (such
as two independent reviewers) through each phase of the
review (that is, screening, eligibility and inclusion in meta-
analysis)
7
Study records -
data collection
process
#11c Describe planned method of extracting data from reports
(such as piloting forms, done independently, in duplicate), any
processes for obtaining and confirming data from investigators
8
Data items #12 List and define all variables for which data will be sought
(such as PICO items, funding sources), any pre-planned data
assumptions and simplifications
8
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Outcomes and
prioritization
#13 List and define all outcomes for which data will be sought,
including prioritization of main and additional outcomes, with
rationale
6
Risk of bias in
individual studies
#14 Describe anticipated methods for assessing risk of bias of
individual studies, including whether this will be done at the
outcome or study level, or both; state how this information will
be used in data synthesis
8
Data synthesis #15a Describe criteria under which study data will be quantitatively
synthesised
9
#15b If data are appropriate for quantitative synthesis, describe
planned summary measures, methods of handling data and
methods of combining data from studies, including any
planned exploration of consistency (such as I2, Kendall’s τ)
9
#15c Describe any proposed additional analyses (such as
sensitivity or subgroup analyses, meta-regression)
10
#15d If quantitative synthesis is not appropriate, describe the type
of summary planned
10
Meta-bias(es) #16 Specify any planned assessment of meta-bias(es) (such as
publication bias across studies, selective reporting within
studies)
10
Confidence in
cumulative
evidence
#17 Describe how the strength of the body of evidence will be
assessed (such as GRADE)
-
The PRISMA-P checklist is distributed under the terms of the Creative Commons Attribution License
CC-BY 4.0. This checklist can be completed online using https://www.goodreports.org/, a tool made
by the EQUATOR Network in collaboration with Penelope.ai
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For peer review onlyRehabilitation for balance impairment in patients after
stroke: a protocol of a systematic review and network meta-analysis
Journal: BMJ Open
Manuscript ID bmjopen-2018-026844.R1
Article Type: Protocol
Date Submitted by the Author: 13-Feb-2019
Complete List of Authors: Li, Juan; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZhong, Dongling; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationYe, Jing; Chengdu University of Traditional Chinese Medicine, School of Acupuncture-Moxibustion and Tuina/The Third Affiliated HospitalHe, Mingxing; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationLiu, Xicen; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZheng, Hui ; Chengdu University of Traditional Chinese Medicine, School of Acupuncture-Moxibustion and Tuina/The Third Affiliated HospitalJin, Rongjiang; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZhang, Shao-lan; Chengdu Medical College, Immunology teaching and research section
<b>Primary Subject Heading</b>: Evidence based practice
Secondary Subject Heading: Rehabilitation medicine, Evidence based practice, Complementary medicine
Keywords:Protocols & guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Rehabilitation medicine < INTERNAL MEDICINE, STROKE MEDICINE, THERAPEUTICS, COMPLEMENTARY MEDICINE
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BMJ Open
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1
Rehabilitation for balance impairment in patients after stroke: a
protocol of a systematic review and network meta-analysis
Juan Li1†, Dongling Zhong1†, Jing Ye2†, Mingxing He1, Xicen Liu1, Hui Zheng2, Rongjiang
Jin1*, Shaolan Zhang3*
1. School of Health Cultivation and Rehabilitation, Chengdu University of Traditional
Chinese Medicine, Chengdu, Sichuan, China
2. School of Acupuncture-Moxibustion and Tuina/The Third Affiliated Hospital, Chengdu
University of Traditional Chinese Medicine, Chengdu, Sichuan, China
3. Chengdu Medical College, Chengdu, Sichuan, China
†Juan Li, Dongling Zhong and Jing Ye contributed equally to this work.
Emails of authors: [email protected]; [email protected]; [email protected];
[email protected]; [email protected]; [email protected];
*Corresponding authors: Professor Rongjiang Jin or Professor Shaolan Zhang, School of
Health Cultivation and Rehabilitation, Chengdu University of Traditional Chinese
Medicine, Chengdu, Sichuan, 610075, China; Chengdu Medical College, Chengdu, Sichuan,
610500, China.
E-mail: [email protected]; [email protected].
Abstract
Introduction
Multiple rehabilitation therapies have been reported effective for post-stroke balance
impairment. However, the comparative effectiveness of these rehabilitation therapies is
still unclear. Therefore, the aim of this study is to summarize evidence and identify the
most effective rehabilitation therapy for post-stroke balance impairment.
Methods and analysis
The following databases will be searched: China Biology Medicine disc (CBM), China
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National Knowledge Internet (CNKI), Wan Fang Data, the Chinese Science and
Technology Periodical Database (VIP), Medline, EMBASE, Web of Science, The
Cochrane Library from inception to September 2018. All randomized controlled trials
(RCTs) that have utilized rehabilitation interventions to treat post-stroke balance
impairment will be included. The primary outcomes are the Berg Balance Scale (BBS),
the Fugl-Meyer Assessment (FMA (balance)), the Postural Assessment Scale for Stroke
(PASS), as well as the Function In Sitting Test (FIST), the Sitting Balance Scale (SBS),
the Ottawa Sitting Scale, the Activities-specific Balance Confidence scale (ABC), the
Overall Balance Index (OBI) and the Brunel Balance Assessment (BBA). The
secondary outcomes include the Barthel Index (BI), The Functional Ambulation
Category Scale (FAC), fall rates, the Timed Up-and-go test (TUG), the MOS 36-item
short-form health survey (SF-36), and adverse events. To ensure that all relevant studies
will be included without personal bias, study selection, data extraction and quality
assessment will be performed independently by two reviewers. Risk of bias will be
assessed with the Cochrane risk of bias assessment tool. Review Manager V5.3
software will be used to make bias risk diagram and pairwise meta-analysis, while
network data synthesis will be performed using WinBUGS 1.4.3 and R software.
Ethics and dissemination
Ethics approval is not required in systematic review and network meta-analysis. The
results will be submitted to a peer review journal.
Trial registration number: PROSPERO (CRD 42018107441)
Strengths and limitations of this study
This study will be the first network meta-analysis to compare the effectiveness and
safety of different rehabilitation physiotherapists for post-stroke balance
impairment.
The results of this study will provide evidence for the management of balance
impairment and help the therapists and patients to choose suitable treatment.
In order to ensure that all relevant studies will be included without personal bias,
study selection, data extraction and quality assessment will be performed
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independently by two reviewers.
Although both electronic search and hand search will be performed in this study,
potential unpublished trials are inevitable. To overcome this limitation, the experts
in this field will be consulted for unpublished trials.
Owing to the difficulty of locating all the effective rehabilitation therapies for post-
stroke balance impairment, we will review the guideline and consult the experts for
the recommended rehabilitation therapies.
1 Introduction
Stroke is a common clinical cerebrovascular disease, with high morbidity, mortality,
and disability rates, which brings a heavy economic burden to society and families1-3.
It is reported that about 83% of stroke survivors suffered from balance impairment.
Balance impairment is characterized by short supporting time and differences between
two sides of the body and slow walking speed, which may increase the risk of falls4 and
restrict participation in activities5. Fear of falling can contribute to sedentary lifestyle
and increased disability, which means lower quality of life6.
Falling often leads to longer hospital stay, more medical and nursing costs, and
economic losses directly or indirectly. It is reported that in China, annual medical
expenses caused by cerebrovascular falls exceed 5 billion yuan, resulting in a direct or
indirect social cost of approximately 160 to 80 billion yuan7. Therefore, management
of balance impairment is challenging for patients with stroke.
Balance is the ability to maintain the line of gravity within the base of support with
minimal postural sway8. The control of human balance is a comprehensive process
relying on the integration of visual, vestibular and somatosensory inputs in the central
nervous system. Numerous rehabilitation therapies have been used to improve balance
ability of stroke patients including whole body vibration (WBV)9, virtual reality (VR)10
11, exercise12, mirror therapy (MT)13-15, traditional Chinese medicine (TCM)16,
traditional Chinese exercise (TCE)17-20, ankle-foot orthosis (AFO)21 and so on.
It is reported that WBV is able to improve results of the Functional Reach Test and the
Timed Up-and-go test (TUG), which has a positive effect on the balance and gait
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function of stroke patients22. Results of one RCT concluded that VR is an effective
rehabilitation therapy which can improve postural balance and upper extremity function
in post-stroke patients23. Exercises such as bilateral upper extremity exercises24, step
climbing exercise25 and trampoline training26 are beneficial for balance ability and fall
prevention. Recent systematic reviews and meta-analyses showed that MT can improve
balance, mobility, gait speed, and motor function compared to control groups13-15. AFO
is capable to improve the gait and balance in patient with balance impairment after
stroke27. Acupuncture is an important part of TCM, which has been used to restore limb
movement and balance disability in patients with stroke16. Results from several meta-
analysis showed that TCE including Tai Chi, Baduanjin, Yijinjing, Liuzijue and so on
can effectively enhance the balance ability by increasing the Berg Balance Scale score
and reducing fall rate19.
Based on these grounds, we raise an important clinical question: among these
rehabilitation therapies, which is the most comparative effective and safe therapy to
enhance balance ability for post-stroke patients.
Different from traditional pairwise meta-analysis, network meta-analysis (NMA) is
capable to summarize the direct and indirect evidence and evaluate the relative efficacy
of multiple treatment comparisons. What is more, NMA is able to provide the ranking
of treatment options based on their effectiveness. Therefore, to help physiotherapists
and patients make better choice in improving balance, a systematic review and NMA
will be conducted to summarize the evidence of various rehabilitation therapies and to
identify the most effective rehabilitation therapy for post-stroke balance impairment.
2 Methods
2.1 Registration
The protocol of this NMA has been registered with the international prospective register
of systematic reviews (PROSPERO, http://www.crd.york.ac.uk/PROSPERO). The
registration number of this NMA is CRD 42018107441. The protocol will be reported
in accordance with the guidelines of the Preferred Reporting Item for Systematic
Review and Meta-analysis Protocols (PRISMA-P). The procedure of this review is
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shown in figure 1.
2.2 Inclusion criteria
Type of studies
Only randomized controlled trials (RCTs) will be included. Trials without control group
or those with quasi-random allocation will be excluded. There will be no restrictions on
language or publication date.
Types of participants
We will include RCTs that involved post-stoke patients diagnosed according to the
stroke diagnostic criteria formulated by The Fourth National Cerebrovascular Disease
Conference in 199528, A Guide to the Prevention and Treatment of Chinese
Cerebrovascular Disease developed by the Chinese Medical Association in 200529,
Standard for the Diagnosis and Evaluation of Stroke Difficulties formulated by the
Encephalopathy Emergency Team of the State Administration of Traditional Chinese
Medicine in 199630. There will be no restriction on age, sex and race.
Types of interventions
Experts were consulted for the recommended rehabilitation therapies. All kinds of
rehabilitation therapies for post-stroke balance impairment including traditional
Chinese medicine therapies (such as acupuncture moxibustion, Tai Chi and so on) and
modern rehabilitation therapies (which refer to physical therapies defined by the World
Confederation for Physical Therapy (WCPT) (http://www.wcpt.org/policy/ps-
descriptionPT)), typically including balance-specific activities (such as balance
exercises, weight shift training and so on), more general activities (such as
strengthening exercises, gait activities and so on), biofeedback, WBV, VR, MT,
orthosis and so on.
Outcome measurements
Primary outcomes will focus on balance ability. Secondary outcomes will include
functional ambulatory ability as well as quality of life.
Primary outcomes
The primary outcomes include the Berg Balance Scale (BBS), the Postural Assessment
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Scale for Stroke (PASS) and the Fugl-Meyer Assessment (FMA(balance))31, as well as
the Function In Sitting Test (FIST), the Sitting Balance Scale (SBS), the Ottawa Sitting
Scale, the Activities-specific Balance Confidence (ABC) scale, the Overall Balance
Index (OBI) and the Brunel Balance Assessment (BBA).
BBS assesses the functional postural abilities of patients in several conditions (lying on
the back, sitting, standing, leaning forward, change of position and so on). This scale is
composed of 14 items. The maximal score, reflecting the best functional postural
abilities, is 56 points32-34.
FMA (balance) as a method for assessing the balance was developed from the
Brunnstrom Level 6 functional grading. This scale is composed of 7 items with 3 levels. The maximal score is 14 points. Lower score means more severe balance impairment35.
PASS was developed specifically for assessing balance in stroke patients. PASS
demonstrates high reliability36, favorable individual item agreement37, and high test-
retest reliability38 39.
Secondary outcomes
The secondary outcomes will include the Barthel Index (BI), The Functional
Ambulation Category Scale (FAC), fall rates, TUG, The MOS 36-item short-form
health survey (SF-36), adverse events.
BI is used as standard measures for activities of daily living and motor function40. FAC
is an assessment tool designed to categorize functional ambulation ability. TUG is a
simple test used to assess a person's mobility and requires both static and dynamic
balance41.
2.3 Exclusion criteria
The following will be excluded: ①non-RCTs, cluster randomized trials, cross-over
designs, cohort studies, reviews, case-control studies. ② balance impairment not
caused by stroke, for example, caused by Parkinson’s disease, Pediatric cerebral palsy,
knee surgery or other diseases. ③duplicate or un-extracted data. ④full text can’t be
obtained through various approaches.
2.4 Data sources and search
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The following databases will be searched from inception to September 2018: China
Biology Medicine disc (CBM), China National Knowledge Internet (CNKI), Wan Fang
Data, the Chinese Science and Technology Periodical Database (VIP), Medline,
EMBASE, Web of Science, The Cochrane Library. And we will also search RCT
registration website, including http://www.ClinicalTrial.gov and
http://www.chictr.org.cn. A professional medical librarian (HZ) will design and revise
the search strategy. Relevant magazines and websites will be searched to avoid missing
eligible trials. References list of identified publications will also be manually searched.
Experts in this field will be consulted for unpublished trials. Search strategy please see
AppendixⅠ.
2.5 Studies selection
All the retrieved studies will be imported into Endnote(X8) and the duplicated studies
will be deleted. Two reviewers (DLZ and MXH) will screen the titles and abstracts
independently according to the inclusion and exclusion criteria then cross check. Two
reviewers (DLZ and MXH) will download the full texts of all possibly relevant studies
for further assessment independently then cross check. In case of disagreements, two
reviewers (DLZ and MXH) will resolve through team discussion or a third reviewer
(RJJ) will be involved.
2.6 Data extraction
A standardized data extraction form will be designed in advance. After identifying all
the included studies, two reviewers (DLZ and MXH) will independently extract data,
including study characteristics (author and published year), participant characteristics
(simple size, age, sex, disease course and so on), interventions (duration, frequency,
study period and so on), comparisons (duration, frequency, study period and so on),
outcomes (BBS, FMA (balance), BI, SF-36 and so on). Then two reviewers (DLZ and
MXH) will cross check to make sure there is no mistake. In case of disagreements, two
reviewers (DLZ and MXH) will resolve through discussion or a third reviewer (SLZ)
will be involved.
2.7 Risk of bias assessment
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The Cochrane risk of bias tool (www.cochrane-handbook.org.)42 will be used to assess
the risk of bias including the following items: random sequence generation, allocation
concealment, blinding of participants and personnel, blinding of outcome assessment,
incomplete outcome data, selective reporting and other bias. If the study meets all
criteria, it will be categorized as low risk of bias; the trials with insufficient information
to judge will be categorized as unclear risk of bias; the trials that meet none of the
criteria will be categorized as high risk of bias. Two reviewers (XCL and JL) will assess
the risk of bias independently then cross check to make sure no mistake. In case of
disagreements, two reviewers (XCL and JL) will resolve through discussion or a third
reviewer (RJJ) will be involved. Review Manager V5.3 software will be used to make
bias risk diagram.
2.8 Grading the quality of evidence
To help health professional make decisions regarding individual patients, two qualified
reviewers (JY and JL, who were certificated by Chinese Cochrane Centre) will
independently evaluate the quality of evidence for outcomes by using the
Grades of Recommendations, Assessment, Development and Evaluation (GRADE)
system (http://www.gradeworkinggroup.org/society/index.htm). The GRADE includes
the following five aspects: limitations in study design, inconsistency, indirectness,
imprecision, and publication bias43. The quality of evidence will be graded as ‘high’,
‘moderate’, ‘low’ or ‘very low’ in accordance with the GRADE rating standards44. The
results of GRADE including evidence profile (EP) and summary of finding table (SoF)
will be generated using GRADE pro software.
2.9 Patient and public involvement
No patients were involved in writing this protocol of NMA. However, the results will
be disseminated to post-stroke patients suffering from balance impairment.
2.10 Statistical analysis
Pairwise meta-analysis
The characteristics of the included RCTs will be summarized. The clinical
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heterogeneity in the included RCTs will be checked through examination of patients’
baseline characteristics. For continuous data, standardized mean difference (SMD) will
be calculated; for dichotomous data, odds ratios (OR) will be computed. Statistical
heterogeneity across trials will also be assessed with the I2 statistics. If the P value is
≥0.1 and I2 ≤50%, we will synthesize SMD or OR with Mantel–Haenszel method (fixed
effects model). If the P value is <0.1 and I2 >50%, the Der Simonian-Laird method
(random-effects model) will be used.
Network meta-analysis
The Bayesian network analysis will be conducted to compare the effects of different
rehabilitation therapies. The Markov Chain Monte Carlo (MCMC) algorithm will be
performed. A total of 5000 simulations for each chain will be defined as the ‘burn-in’
period. Then, posterior summaries will be based on 200 000 subsequent simulations.
The Brooks–Gelman–Rubin plots method will be used to assess model convergence.
The node splitting will be performed to check inconsistency when compare the indirect
evidence with direct evidence. We will adopt the deviance information criterion (DIC)
to explore the model fitness, in which the fixed and random effects model will be
compared.
Since primary outcomes are continuous data, the effect size of the rehabilitation
therapies will be calculated with the standardized mean difference (SMD) with 95%
confidence intervals (CIs), while dichotomous outcomes will be presented as OR with
95% CIs. The 95% CIs of each SMD will also be calculated.
For each outcome, the rankogram plots and the surface under the cumulative ranking
curves (SUCRA) will be used to estimate the hierarchy of the different rehabilitation
therapies. A rankogram plots will show the probabilities for rehabilitation therapies to
assume any of the possible rank. SUCRAs will be present as percentage. 100% for the
best treatment while 0% for the worst. Data analysis will be performed using WinBUGS
1.4.3 and R software.
We will perform a narrative review and summarize the evidences, if the available data
are not suitable for synthesis.
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Dealing with missing data
If the extracted data is missing, the original authors will be contacted for more
information. If there were no reply from the original authors, we will try to calculate
the data through the available coefficients, the potential impact of these missing data
on the results of the NMA will be tested in the sensitivity analysis.
Subgroup analysis
Subgroup analysis will be performed to address the potential heterogeneity and
inconsistency. Subgroup analysis will be performed based on age, gender, type of stroke,
disease course of stroke, the severity of balance impairment, the duration of treatment.
Also, the network meta regression will be conducted to explore the possible sources of
heterogeneity.
Sensitivity analysis
Sensitivity analysis of primary outcomes will be carried out to verify the robustness of
the study conclusions, assessing the impact of methodological quality, study design,
sample size and the effect of missing data as well as the analysis methods on the result
of this review.
Assessment of publication bias
For publication bias, each included study will be assessed according to the CONSORT
criterial. The Egger’s test will be conducted to check whether there is a statistical
significance. If the number of trials reporting the primary outcomes was 10 or more,
funnel plot will be performed to assess the publication bias of the included studies. If
funnel plots are asymmetric, we will try to interpret funnel plot asymmetry45.
3 Discussion
Balance impairment is one of the common impairments in patients after stroke, which
are related to worse physical impairments, disability and low quality of life. Moreover,
balance impairment often leads to high fall rates, which brings great burden to stroke
patients, families and society. In addition, good balance ability is the prerequisite for
recovering the ability of independent walking and activities of daily living.
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Current rehabilitation therapies including WBV, VR, exercise, MT, AFO, TCM, TCE
have been used to improve the balance ability of stroke patients. Several meta-analyses
of head to head comparisons have been carried out to investigate the comparative
efficacy and safety of these rehabilitation therapies. However, previous meta-analyses
failed to assess the comparative efficacy and acceptability of all the available
rehabilitation therapies. NMA is needed to determine the comparative effects of these
rehabilitation therapies.
To our knowledge, this will be the first NMA to investigate the rehabilitation therapies
for balance impairment in patients after stroke. On the basis of comparative
effectiveness evidence, this NMA is expected to provide a ranking of these therapies
for balance impairment in stroke patients. The results of this NMA could help the
patients and therapists to choose their best preference for balance impairment.
Moreover, we also hope that the results of this study may provide evidence for the
guidelines recommendations.
Ethics and dissemination
Ethics approval is not required in NMA. The results will be reported in accordance with
PRISMA. The findings will be submitted to peer review journal or conference.
Contributors: JL, DLZ and JY contributed equally to the work as first authors.
Study concept and design: RJJ and SLZ.
Acquisition of data: JL, DLZ, MXH, HZ and XCL.
Drafting of the manuscript: JL, DLZ and JY.
Critical revision of the manuscript for important intellectual content: All authors.
Supervision: RJJ.
All authors approved the publication of this protocol.
Acknowledgments
We would like to explicitly thank Yu Hu from Cardiff University for language
copyediting.
Funding: This work was financially funded by the National Natural Science
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Foundation of China (grant numbers 81674047 and 81704137).
Competing interests: None declared.
Data sharing statement: No additional data.
Provenance and peer review: Not commissioned; externally peer reviewed.
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Figure 1 flowchart of network meta-analysis of rehabilitation for the balance impairment in patients with stroke (Abbreviation: CBM: China Biology Medicine disc, CNKI: China National Knowledge Internet, VIP: the Chinese Science and Technology Periodical Database)
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Figure 1 flowchart of network meta-analysis of rehabilitation for the balance impairment in post-stroke patients (Abbreviation: CBM: China Biology Medicine disc, CNKI: China National Knowledge Internet, VIP:
the Chinese Science and Technology Periodical Database)
101x101mm (300 x 300 DPI)
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Appendix Ⅰ. search strategy.
number Search terms
1 cerebrovascular disorders OR cerebrovascular OR brain ischemia OR stroke OR
brain infarction OR CVA OR post-stroke OR poststroke OR cerebrovasc* OR
hemiplegia
2 balance OR posture OR postural balance OR balance impairment OR equilibrium
OR weight bearing OR weight shift OR postural control OR postural stability OR
postural instability OR postural disorders
3 physical therapy OR physical therapy modality OR physical therapy techniques OR
physiotherapy OR group physiotherapy OR neurological physiotherapy OR
neurophysiotherapy OR exercise movement techniques OR neurorehabilitation OR
rehabilitation
4 whole body vibration OR plantar vibration OR weight movement training weight
shift training OR treadmill training OR balance training OR balance exercises OR
ankle proprioceptive control OR virtual reality OR mirror therapy OR biofeedback
OR YOGA OR exercises OR training OR kinesiology taping OR orthosis
5 acupuncture OR electroacupuncture OR fire needle OR body acupuncture OR warm
needle OR auricular acupuncture OR Tuina OR Chinese tuina OR massage OR
massage therapy OR Chinese massage OR Chinese manipulation OR Chinese
manipulative therapy OR Chinese manipulation OR moxibustion OR Chinese
medicine OR traditional Chinese exercises
6 randomized controlled trial OR controlled clinical trial OR randomly OR
randomized OR randomized trial
7 1 AND 2 AND 3 AND 4 AND 5 AND 6
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Reporting checklist for protocol of a systematic review.
Based on the PRISMA-P guidelines.
Instructions to authors
Complete this checklist by entering the page numbers from your manuscript where readers will find
each of the items listed below.
Your article may not currently address all the items on the checklist. Please modify your text to
include the missing information. If you are certain that an item does not apply, please write "n/a" and
provide a short explanation.
Upload your completed checklist as an extra file when you submit to a journal.
In your methods section, say that you used the PRISMA-P reporting guidelines, and cite them as:
Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA. Preferred
Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement.
Syst Rev. 2015;4(1):1.
Reporting Item
Page
Number
Identification #1a Identify the report as a protocol of a systematic review 1
Update #1b If the protocol is for an update of a previous systematic
review, identify as such
n/a
#2 If registered, provide the name of the registry (such as
PROSPERO) and registration number
1/4
Contact #3a Provide name, institutional affiliation, e-mail address of all
protocol authors; provide physical mailing address of
corresponding author
1
Contribution #3b Describe contributions of protocol authors and identify the
guarantor of the review
1
#4 If the protocol represents an amendment of a previously
completed or published protocol, identify as such and list
changes; otherwise, state plan for documenting important
protocol amendments
n/a
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Sources #5a Indicate sources of financial or other support for the review 11
Sponsor #5b Provide name for the review funder and / or sponsor 11
Role of sponsor or
funder
#5c Describe roles of funder(s), sponsor(s), and / or
institution(s), if any, in developing the protocol
-
Rationale #6 Describe the rationale for the review in the context of what
is already known
3-4
Objectives #7 Provide an explicit statement of the question(s) the review
will address with reference to participants, interventions,
comparators, and outcomes (PICO)
4-6
Eligibility criteria #8 Specify the study characteristics (such as PICO, study
design, setting, time frame) and report characteristics (such
as years considered, language, publication status) to be
used as criteria for eligibility for the review
4-6
Information
sources
#9 Describe all intended information sources (such as
electronic databases, contact with study authors, trial
registers or other grey literature sources) with planned
dates of coverage
7
Search strategy #10 Present draft of search strategy to be used for at least one
electronic database, including planned limits, such that it
could be repeated
Appendix
/15
Study records -
data management
#11a Describe the mechanism(s) that will be used to manage
records and data throughout the review
7
Study records -
selection process
#11b State the process that will be used for selecting studies
(such as two independent reviewers) through each phase
of the review (that is, screening, eligibility and inclusion in
meta-analysis)
7
Study records -
data collection
process
#11c Describe planned method of extracting data from reports
(such as piloting forms, done independently, in duplicate),
any processes for obtaining and confirming data from
investigators
7-8
Data items #12 List and define all variables for which data will be sought
(such as PICO items, funding sources), any pre-planned
data assumptions and simplifications
7
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Outcomes and
prioritization
#13 List and define all outcomes for which data will be sought,
including prioritization of main and additional outcomes,
with rationale
5-6
Risk of bias in
individual studies
#14 Describe anticipated methods for assessing risk of bias of
individual studies, including whether this will be done at the
outcome or study level, or both; state how this information
will be used in data synthesis
7-8
Data synthesis #15a Describe criteria under which study data will be
quantitatively synthesised
8-9
#15b If data are appropriate for quantitative synthesis, describe
planned summary measures, methods of handling data and
methods of combining data from studies, including any
planned exploration of consistency (such as I2, Kendall’s τ)
8-9
#15c Describe any proposed additional analyses (such as
sensitivity or subgroup analyses, meta-regression)
10
#15d If quantitative synthesis is not appropriate, describe the
type of summary planned
10
Meta-bias(es) #16 Specify any planned assessment of meta-bias(es) (such as
publication bias across studies, selective reporting within
studies)
10
Confidence in
cumulative
evidence
#17 Describe how the strength of the body of evidence will be
assessed (such as GRADE)
8
The PRISMA-P checklist is distributed under the terms of the Creative Commons Attribution License
CC-BY 4.0. This checklist can be completed online using https://www.goodreports.org/, a tool made
by the EQUATOR Network in collaboration with Penelope.ai
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For peer review onlyRehabilitation for balance impairment in patients after
stroke: a protocol of a systematic review and network meta-analysis
Journal: BMJ Open
Manuscript ID bmjopen-2018-026844.R2
Article Type: Protocol
Date Submitted by the Author: 24-Apr-2019
Complete List of Authors: Li, Juan; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZhong, Dongling; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationYe, Jing; Chengdu University of Traditional Chinese Medicine, School of Acupuncture-Moxibustion and Tuina/The Third Affiliated HospitalHe, Mingxing; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationLiu, Xicen; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZheng, Hui ; Chengdu University of Traditional Chinese Medicine, School of Acupuncture-Moxibustion and Tuina/The Third Affiliated HospitalJin, Rongjiang; Chengdu University of Traditional Chinese Medicine, School of Health Cultivation and RehabilitationZhang, Shao-lan; Chengdu Medical College, Immunology teaching and research section
<b>Primary Subject Heading</b>: Evidence based practice
Secondary Subject Heading: Rehabilitation medicine, Evidence based practice, Complementary medicine
Keywords:Protocols & guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Rehabilitation medicine < INTERNAL MEDICINE, STROKE MEDICINE, THERAPEUTICS, COMPLEMENTARY MEDICINE
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BMJ Open
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1
Rehabilitation for balance impairment in patients after stroke: a
protocol of a systematic review and network meta-analysis
Juan Li1†, Dongling Zhong1†, Jing Ye2†, Mingxing He1, Xicen Liu1, Hui Zheng2, Rongjiang
Jin1*, Shaolan Zhang3*
1. School of Health Cultivation and Rehabilitation, Chengdu University of Traditional Chinese
Medicine, Chengdu, Sichuan, China
2. School of Acupuncture-Moxibustion and Tuina/The Third Affiliated Hospital, Chengdu
University of Traditional Chinese Medicine, Chengdu, Sichuan, China
3. Chengdu Medical College, Chengdu, Sichuan, China
†Juan Li, Dongling Zhong and Jing Ye contributed equally to this work.
Emails of authors: [email protected]; [email protected]; [email protected];
[email protected]; [email protected]; [email protected];
*Corresponding authors: Professor Rongjiang Jin or Professor Shaolan Zhang, School of
Health Cultivation and Rehabilitation, Chengdu University of Traditional Chinese Medicine,
Chengdu, Sichuan, 610075, China; Chengdu Medical College, Chengdu, Sichuan, 610500, China.
E-mail: [email protected]; [email protected].
Abstract
Introduction
Multiple rehabilitation therapies have been reported to be effective for post-stroke
balance impairment. However, the comparative effectiveness of these rehabilitation
therapies is still unclear. Therefore, the aim of this study is to summarize evidence
and identify the most effective rehabilitation therapy for post-stroke balance
impairment.
Methods and analysis
The following databases will be searched: China Biology Medicine (CBM), China
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National Knowledge Infrastructure (CNKI), Wan Fang Data, the Chinese Science and
Technology Periodical Database (VIP), Medline, EMBASE, Web of Science, The
Cochrane Library from inception to June 2019. All randomized controlled trials
(RCTs) that have utilized rehabilitation interventions to treat post-stroke balance
impairment will be included. The primary outcomes are the Berg Balance Scale
(BBS), the Fugl-Meyer Assessment (FMA (balance)), the Postural Assessment Scale
for Stroke (PASS), as well as the Function In Sitting Test (FIST), the Sitting Balance
Scale (SBS), the Ottawa Sitting Scale, the Activities-specific Balance Confidence
scale (ABC), the Overall Balance Index (OBI) and the Brunel Balance Assessment
(BBA). The secondary outcomes include the Barthel Index (BI), The Functional
Ambulation Category Scale (FAC), fall rates, the Timed Up-and-go test (TUG), the
MOS 36-item short-form health survey (SF-36), and adverse events. To ensure that all
relevant studies will be included without personal bias, study selection, data extraction
and quality assessment will be performed independently by two reviewers. Risk of
bias will be assessed with the Cochrane risk of bias assessment tool. Review Manager
V5.3 software will be used to make bias risk diagram and pairwise meta-analysis,
while network data synthesis will be performed using WinBUGS 1.4.3 and R
software.
Ethics and dissemination
Ethics approval is not required in systematic review and network meta-analysis. The
results will be submitted to a peer review journal.
Trial registration number: PROSPERO (CRD 42018107441)
Strengths and limitations of this study
This study will be the first network meta-analysis to compare the effectiveness
and safety of different rehabilitation physiotherapists for post-stroke balance
impairment.
The results of this study will provide evidence for the management of balance
impairment and help the therapists and patients to choose suitable treatment.
To make sure that all relevant studies will be included without personal bias, two
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reviewers will perform the study selection, data extraction and quality assessment
independently.
Although both electronic search and hand search will be performed in this study,
potential unpublished trials are inevitable. To overcome this limitation, the
experts in this field will be consulted for unpublished trials.
Owing to the difficulty of locating all the effective rehabilitation therapies for
post-stroke balance impairment, we will review the guideline and consult the
experts for the recommended rehabilitation therapies.
1 Introduction
Stroke is a common clinical cerebrovascular disease, with high morbidity, mortality,
and disability rates, which brings a heavy economic burden to society and families1-3.
Balance is the ability to maintain the line of gravity within the base of support with
minimal postural sway4. The control of human balance is a comprehensive process
relying on the integration of visual, vestibular and somatosensory inputs in the central
nervous system. It is reported that about 83% of stroke survivors suffered from
balance impairment. Balance impairment is characterized by short supporting time
and differences between two sides of the body and slow walking speed, which may
increase the risk of falls5. Fear of falling can contribute to sedentary lifestyle and
increased disability, which means lower quality of life6. Falling often leads to longer
hospital stay, more medical and nursing costs, and economic losses directly or
indirectly. In China, annual medical expenses caused by cerebrovascular falls exceed
5 billion yuan, resulting in a direct or indirect social cost of approximately 160 to 80
billion yuan7. Therefore, management of balance impairment is challenging for
patients with stroke.
Numerous rehabilitation therapies have been used to improve balance ability of stroke
patients including whole body vibration (WBV)8, virtual reality (VR)9 10, exercise11,
mirror therapy (MT)12-14, traditional Chinese medicine (TCM)15, traditional Chinese
exercise (TCE)16-18, ankle-foot orthosis (AFO)19 and so on. WBV is able to improve
results of the Functional Reach Test and the Timed Up-and-go test (TUG), which has
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a positive effect on the balance and gait function of stroke patients20. Results of an
RCT concluded that VR is an effective rehabilitation therapy which can improve
postural balance and upper extremity function in post-stroke patients21. Exercises such
as bilateral upper extremity exercises22, step climbing exercise23 and trampoline
training24 are beneficial for balance ability and fall prevention. Recent systematic
reviews and meta-analyses showed that MT can improve balance, mobility, gait
speed, and motor function compared to control groups12-14. AFO is capable to improve
the gait and balance in patient with balance impairment after stroke25. Acupuncture is
an important part of TCM, which has been used to restore limb movement and
balance disability in patients with stroke15. Results from several meta-analyses
showed that TCE including Tai Chi, Baduanjin, Yijinjing, Liuzijue and so on can
effectively enhance the balance ability by increasing the Berg Balance Scale (BBS)
score and reducing fall rate16.
Based on these grounds, we raise an important clinical question: among these
rehabilitation therapies, which is the most comparative effective and safe therapy to
enhance balance ability for post-stroke patients. Different from traditional pairwise
meta-analysis, network meta-analysis (NMA) is capable to summarize the direct and
indirect evidence and evaluate the relative efficacy of multiple treatment comparisons.
What is more, NMA is able to provide the ranking of treatment options based on their
effectiveness. Therefore, to help physiotherapists and patients make better choice in
improving balance, a systematic review and NMA should be conducted to summarize
the evidence of various rehabilitation therapies and to identify the most effective
rehabilitation therapy for post-stroke balance impairment.
2 Methods
2.1 Registration
The protocol of this systematic review and NMA has been registered at the
international prospective register of systematic reviews (PROSPERO,
http://www.crd.york.ac.uk/PROSPERO). The registration number of this NMA is
CRD 42018107441. The protocol will be reported in accordance with the guidelines
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of the Preferred Reporting Item for Systematic Review and Meta-analysis Protocols
(PRISMA-P). The procedure of this review is shown in figure 1.
2.2 Inclusion criteria
Type of studies
Only randomized controlled trials (RCTs) will be included. Trials without control
group or those with quasi-random allocation will be excluded. No restrictions on
language or publication date.
Types of participants
We will include RCTs that involved post-stoke patients diagnosed according to the
stroke diagnostic criteria formulated by The Fourth National Cerebrovascular Disease
Conference in 199526, A Guide to the Prevention and Treatment of Chinese
Cerebrovascular Disease developed by the Chinese Medical Association in 200527,
Standard for the Diagnosis and Evaluation of Stroke Difficulties formulated by the
Encephalopathy Emergency Team of the State Administration of Traditional Chinese
Medicine in 199628. Diagnosis of stroke are summarized as following: Clear stroke
history and manifestations, supported by imaging examination such as cranial plain
Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI). There will
be no restriction on age, sex and race.
Types of interventions
Experts were consulted for the recommended rehabilitation therapies. All kinds of
rehabilitation therapies for post-stroke balance impairment including traditional
Chinese medicine therapies (such as acupuncture, moxibustion, Tai Chi and so on)
and modern rehabilitation therapies (which refer to physical therapies defined by the
World Confederation for Physical Therapy (WCPT)
(http://www.wcpt.org/policy/ps-descriptionPT)), typically including balance-specific
activities (such as balance exercises, weight shift training and so on), more general
activities (such as strengthening exercises, gait activities and so on), biofeedback,
WBV, VR, MT, orthosis and so on.
Outcome measurements
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Primary outcomes will focus on balance ability. Secondary outcomes will include
functional ambulatory ability as well as quality of life.
Primary outcomes
The primary outcomes include BBS, the Postural Assessment Scale for Stroke (PASS)
and the Fugl-Meyer Assessment (FMA(balance))29, as well as the Function In Sitting
Test (FIST), the Sitting Balance Scale (SBS), the Ottawa Sitting Scale, the
Activities-specific Balance Confidence (ABC) scale, the Overall Balance Index (OBI)
and the Brunel Balance Assessment (BBA).
BBS assesses the functional postural abilities of patients in several conditions (lying
on the back, sitting, standing, leaning forward, change of position and so on). This
scale is composed of 14 items. The maximal score, reflecting the best functional
postural abilities, is 56 points30-32. FMA (balance) as a method for assessing the
balance was developed from the Brunnstrom Level 6 functional grading. This scale is
composed of 7 items with 3 levels. The maximal score is 14 points. Lower score
means more severe balance impairment33. PASS was developed specifically for
assessing balance in stroke patients. PASS demonstrates high reliability34, favorable
individual item agreement35, and high test-retest reliability36 37. FIST and SBS both
are scales related to sitting. FIST is a performance-based measure to examine deficits
in seated postural control, which consists of 14 items38, while SBS measures sitting
balance for frail older adults39. ABC scale is a method of balance confidence
evaluation, demanding participants to choose one of percentage points on the scale
from 0% to 100% in 16 items40. OBI is an index to evaluate the ability of controlling
balance in all directions41. BBA is a measure of balance disability post stroke, which
consists of 12 items in three areas (sitting balance, standing balance, walking
function)42.
Secondary outcomes
The secondary outcomes will include the Barthel Index (BI), The Functional
Ambulation Category Scale (FAC), fall rates, TUG, The MOS 36-item short-form
health survey (SF-36), adverse events.
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BI is used as standard measures for activities of daily living and motor function43.
FAC is an assessment tool designed to categorize functional ambulation ability. TUG
is a simple test used to assess a person's mobility and requires both static and dynamic
balance44. SF-36 is a health survey questionnaire, which consists of 36 items in areas
of functional status, well-being, overall evaluation of health and health compared to
one year ago.
2.3 Exclusion criteria
The following will be excluded: ①Study types as following: reviews, cluster RCTs,
cross-over designs, cohort or case-control studies. ②balance impairment not caused
by stroke, for example, caused by Parkinson’s disease, pediatric cerebral palsy, knee
surgery or other diseases. ③duplicate or un-extracted data. ④No access to obtain
full text.
2.4 Data sources and search
Medline, EMBASE, Web of Science, The Cochrane Library, China National
Knowledge Infrastructure (CNKI), China Biology Medicine (CBM), Wan Fang Data
and the Chinese Science and Technology Periodical Database (VIP) databases will be
searched from inception to June 2019. RCT registration website, including
http://www.ClinicalTrial.gov and http://www.chictr.org.cn. will also be searched.
Supplements like magazines, websites and references list of identified publications
will also be searched for candidates. Experts in this field will be consulted for
unpublished trials. Search strategy will be designed by a professional medical
librarian (HZ), which can be seen in AppendixⅠ.
2.5 Studies selection
All the retrieved studies will be imported into Endnote(X8) and the duplicated studies
will be deleted. Two reviewers (DLZ and JY) will screen the titles and abstracts
independently in accordance with the inclusion and exclusion criteria, then cross
check. Two reviewers (DLZ and JY) will download the full texts of all possibly
relevant studies for further assessment independently then cross check. Team
discussion or consulting a third reviewer (JL) will be used to resolve disagreements.
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2.6 Data extraction
Two reviewers (DLZ and JY) will independently extract information using an
advance-designed standardized data extraction form. The extract information include
study characteristics (author and year of publication), participants (sample size, sex,
age, type of stroke, location of lesion, disease course, times of strokes and so on),
interventions (frequency, duration, study period and so on), comparisons (frequency,
duration, study period and so on), outcomes (BBS, FMA (balance), BI, SF-36 and so
on) and adverse events of the included studies. Then two reviewers (DLZ and JY) will
cross check to make sure there is no mistake. Disagreements will be resolved by team
discussion.
2.7 Risk of bias assessment
Risk of bias will be assessed in accordance with the Cochrane risk of bias tool
(www.cochrane-handbook.org.)45, which includes the following items (random
sequence generation, allocation concealment, blinding of participants and personnel,
blinding of outcome assessment, incomplete outcome data, selective reporting and
other bias). The assessment of each item can be rated as ‘low risk of bias’, ‘unclear
risk of bias’ and ‘high risk of bias’, ‘low risk of bias’ means the study meets all
criteria, ‘unclear risk of bias’ means the study with insufficient information to judge,
‘ high risk of bias’ indicates the study meet none of the criteria. Two reviewers (XCL
and JL) will assess the risk of bias independently, then cross check to make sure no
mistake. Disagreement will be settled by consulting a third reviewer (RJJ). Review
Manager V5.3 software will be used to make bias risk diagram.
2.8 Grading the quality of evidence
Two qualified reviewers (DLZ and JL, who were certificated by Chinese GRADE
Centre in Lanzhou) will independently evaluate the quality of evidence for outcomes
by using the Grades of Recommendations, Assessment, Development and Evaluation
(GRADE) system (http://www.gradeworkinggroup.org/society/index.htm). The
GRADE includes the following five aspects: limitations in study design,
inconsistency, indirectness, imprecision, and publication bias46. The quality of
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evidence will be graded as ‘high’, ‘moderate’, ‘low’ or ‘very low’ in accordance with
the GRADE rating standards47. The results of GRADE including evidence profile
(EP) and summary of finding table (SoF) will be generated using GRADE pro
software.
2.9 Patient and public involvement
No patients were involved in writing this protocol of systematic review and NMA.
However, the results will be disseminated to post-stroke patients suffering from
balance impairment.
2.10 Statistical analysis
Pairwise meta-analysis
The characteristics of the included RCTs will be summarized. The clinical
heterogeneity in the included RCTs will be checked through examination of patients’
baseline characteristics. For continuous data, standardized mean difference (SMD)
will be calculated; for dichotomous data, odds ratios (OR) will be computed.
Statistical heterogeneity across trials will also be assessed with the I2 statistics. If the
P value is ≥0.1 and I2 ≤50%, we will synthesize SMD or OR with fixed effects model
(FEM). If the P value is <0.1 and I2 >50%, the random-effects model (REM) will be
used.
Network meta-analysis
The Bayesian network analysis will be conducted to compare the effects of different
rehabilitation therapies. The Markov Chain Monte Carlo (MCMC) algorithm will be
performed. A total of 5000 simulations for each chain will be defined as the ‘burn-in’
period. Then, posterior summaries will be based on 200 000 subsequent simulations.
The Brooks–Gelman–Rubin plots method will be used to assess model convergence.
The node splitting will be performed to check inconsistency when compare the
indirect evidence with direct evidence. We will adopt the deviance information
criterion (DIC) to explore the model fitness, in which the fixed and random effects
model will be compared.
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Since primary outcomes are continuous data, the effect size of the rehabilitation
therapies will be calculated with the standardized mean difference (SMD) with 95%
confidence intervals (CIs), while dichotomous outcomes will be presented as OR with
95% CIs. The 95% CIs of each SMD will also be calculated.
For each outcome, the rankogram plots and the surface under the cumulative ranking
curves (SUCRA) will be used to estimate the hierarchy of the different rehabilitation
therapies. A rankogram plots will show the probabilities for rehabilitation therapies to
assume any of the possible rank. SUCRAs will be present as percentage, 100% for the
best treatment while 0% for the worst. Data analysis will be performed using
WinBUGS 1.4.3 and R software. We will perform a narrative review and summarize
the evidences, if the available data are not suitable for synthesis.
Dealing with missing data
The original authors will be contacted for more information of the missing data. In the
absence of a reply, we will try to calculate the data through the available coefficients,
the potential impact of these missing data on the results of the NMA will be tested in
sensitivity analysis.
Subgroup analysis
Subgroup analysis will be performed to address the potential heterogeneity and
inconsistency. Subgroup analysis will be performed based on age, gender, type of
stroke, disease course of stroke (within 6 months or after 6 months), location of
lesion, times of stroke, the severity of balance impairment (BBS will be taken to
define the severity of balance impairment. 0~20: poor balance ability; 20~40: fair
balance ability; 41~56: good balance ability) and the duration of treatment.
Meanwhile, the network meta regression will be conducted to explore the possible
sources of heterogeneity.
Sensitivity analysis
To verify the robustness of the study conclusions, sensitivity analysis of primary
outcomes will be carried out, assessing the impact of methodological quality, study
quality, sample size and the effect of missing data as well as the analysis methods on
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the result of this review.
Assessment of publication bias
Each included study will be assessed according to the CONSORT criterial. The
Egger’s test and funnel plot will be conducted to assess the publication bias of the
included studies for primary outcomes. If funnel plots were asymmetric, we will try to
interpret funnel plot asymmetry48.
3 Discussion
Balance impairment is one of the common impairments in patients after stroke, which
is related to worse physical impairments, disability and low quality of life. Moreover,
balance impairment often leads to high fall rates, which brings great burden to stroke
patients, families and society. In addition, good balance ability is the prerequisite for
recovering the ability of independent walking and activities of daily living.
Current rehabilitation therapies including WBV, VR, exercise, MT, AFO, TCM, TCE
have been used to improve the balance ability of stroke patients. Several
meta-analyses of head to head comparisons have investigated the comparative
efficacy and safety of these rehabilitation therapies. So far, no NMA has been
conducted to assess the comparative efficacy and acceptability of all the available
rehabilitation therapies. Therefore, NMA is needed to determine the comparative
effects of these rehabilitation therapies.
To our knowledge, this will be the first systematic review and NMA to investigate the
rehabilitation therapies for balance impairment in patients after stroke. On the basis of
comparative effectiveness evidence and safety, this NMA is expected to provide a
ranking of these therapies for balance impairment in stroke patients. The results of
this NMA could help the patients and therapists to choose their best preference for
balance impairment. Moreover, we also hope that the results of this study may provide
evidence for the guidelines recommendations.
Ethics and dissemination
Ethics approval is not required in NMA. The results will be reported in accordance
with PRISMA. The findings will be submitted to peer review journal or conference.
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Contributors: JL, DLZ and JY contributed equally to the work as first authors.
Study concept and design: RJJ and SLZ.
Acquisition of data: JL, DLZ, MXH, HZ and XCL.
Drafting of the manuscript: JL, DLZ and JY.
Critical revision of the manuscript for important intellectual content: All authors.
Supervision: RJJ.
All authors approved the publication of this protocol.
Acknowledgments
We would like to explicitly thank Yu Hu from Cardiff University for language
copyediting.
Funding: This work was financially funded by the National Natural Science
Foundation of China (grant numbers 81674047 and 81704137).
Competing interests: None declared.
Data sharing statement: No additional data.
Provenance and peer review: Not commissioned; externally peer reviewed.
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international medical journal of experimental and clinical research 2018;24:2590-98.
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doi: 10.12659/msm.906451 [published Online First: 2018/04/28]
22. Shin JW, Don Kim K. The effect of enhanced trunk control on balance and falls through
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23. Park KH, Kim DY, Kim TH. The effect of step climbing exercise on balance and step
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24. Hahn J, Shin S, Lee W. The effect of modified trampoline training on balance, gait, and
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25. Shin YJ, Lee DH, Kim MK. The effect of newly designed multi joint ankle foot orthosis on
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26. Association TtCDCotCM. Various types of diagnosis of cerebrovascular diseases.
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of Beijing University of Traditional Chinese Medicine 1996,19(1):55-56
29. Fugl-Meyer AR, Jaasko L, Leyman I, et al. The post-stroke hemiplegic patient. 1. a
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method for evaluation of physical performance. Scandinavian journal of rehabilitation
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30. Tyson SF DL. Reliability and validity of functional balance tests post stroke. Clin Rehabil
2004;18:916–23
31. Yelnik A BI. Clinical tools for assessing balance disorders. Neurophysiol Clin
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32. Blum L K-BN. Usefulness of the berg balance scale in stroke rehabilitation: a systematic
review. Phys Ther 2008;88:559–66
33. AR F-M. Post strok heimplgia assessment of physical properties. Scand J Rehab Med
1980, 7: 85
34. Benaim C, Perennou DA, Villy J, et al. Validation of a standardized assessment of
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(PASS). Stroke 1999;30(9):1862-8. [published Online First: 1999/09/02]
35. Hui-Fen M, I-Ping H, Pei-Fang T, et al. Analysis and comparison of the psychometric
properties of three balance measures for stroke patients. Stroke 2002;33(4):1022-27.
36. Chien CW, Hu MH, Tang PF. A Comparison of Psychometric Properties of the Smart
Balance Master System and the Postural Assessment Scale for Stroke in People
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37. Lih-Jiun L, Ching-Lin H, Sing-Kai L, et al. The relative and absolute reliability of two
balance performance measures in chronic stroke patients. Disability & Rehabilitation
2008;30(9):656-61.
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38. Gorman SL, Rivera M, McCarthy L. Reliability of the Function in Sitting Test (FIST).
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41. Mohan G, Pal PK, Sendhil KR, et al. Quantitative evaluation of balance in patients with
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43. Mudaliar M R YSR, Tejashwani P P, et al. Quality of Life in Stroke Patients Using SSQoL
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44. Weng C S TZ, Min L I. The value of the timed “up and go” test at the evaluation of
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45. Higgins JP AD, Gøtzsche PC, et al. The Cochrane Collaboration's tool for assessing risk
of bias in randomised trials. BMJ 2011; 343: d5928
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Figure 1 flowchart of network meta-analysis of rehabilitation for the balance impairment in patients with stroke (Abbreviation: CBM: China Biology Medicine, CNKI: China National Knowledge Infrastructure, VIP: the Chinese Science and Technology Periodical Database)
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Figure 1 flowchart of network meta-analysis of rehabilitation for the balance impairment in post-stroke patients (Abbreviation: CBM: China Biology Medicine, CNKI: China National Knowledge Infrastructure, VIP:
the Chinese Science and Technology Periodical Database)
101x101mm (300 x 300 DPI)
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Appendix Ⅰ. search strategy.
number Search terms#1 cerebrovascular disorders OR cerebrovascular OR brain ischemia OR stroke OR
brain infarction OR CVA OR post-stroke OR poststroke OR cerebrovasc* OR hemiplegia
#2 balance OR posture OR postural balance OR balance impairment OR equilibrium OR weight bearing OR weight shift OR postural control OR postural stability OR postural instability OR postural disorders
#3 physical therapy OR physical therapy modality OR physical therapy techniques OR physiotherapy OR group physiotherapy OR neurological physiotherapy OR neurophysiotherapy OR exercise movement techniques OR neurorehabilitation OR rehabilitation
#4 whole body vibration OR plantar vibration OR weight movement training weight shift training OR treadmill training OR balance training OR balance exercises OR ankle proprioceptive control OR virtual reality OR mirror therapy OR biofeedback OR YOGA OR exercises OR training OR kinesiology taping OR orthosis
#5 acupuncture OR electroacupuncture OR fire needle OR body acupuncture OR warm needle OR auricular acupuncture OR Tuina OR Chinese tuina OR massage OR massage therapy OR Chinese massage OR Chinese manipulation OR Chinese manipulative therapy OR Chinese manipulation OR moxibustion OR Chinese medicine OR traditional Chinese exercises
#6 randomized controlled trial OR controlled clinical trial OR randomly OR randomized OR randomized trial
#7 #1 AND #2 AND (#3 OR #4 OR #5) AND #6
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Reporting checklist for protocol of a systematic review.
Based on the PRISMA-P guidelines.
Instructions to authors
Complete this checklist by entering the page numbers from your manuscript where readers will find
each of the items listed below.
Your article may not currently address all the items on the checklist. Please modify your text to
include the missing information. If you are certain that an item does not apply, please write "n/a" and
provide a short explanation.
Upload your completed checklist as an extra file when you submit to a journal.
In your methods section, say that you used the PRISMA-P reporting guidelines, and cite them as:
Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA. Preferred
Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement.
Syst Rev. 2015;4(1):1.
Reporting Item
Page
Number
Identification #1a Identify the report as a protocol of a systematic review 1
Update #1b If the protocol is for an update of a previous systematic
review, identify as such
n/a
#2 If registered, provide the name of the registry (such as
PROSPERO) and registration number
1/4
Contact #3a Provide name, institutional affiliation, e-mail address of all
protocol authors; provide physical mailing address of
corresponding author
1
Contribution #3b Describe contributions of protocol authors and identify the
guarantor of the review
1
#4 If the protocol represents an amendment of a previously
completed or published protocol, identify as such and list
changes; otherwise, state plan for documenting important
protocol amendments
n/a
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Sources #5a Indicate sources of financial or other support for the review 11
Sponsor #5b Provide name for the review funder and / or sponsor 11
Role of sponsor or
funder
#5c Describe roles of funder(s), sponsor(s), and / or
institution(s), if any, in developing the protocol
-
Rationale #6 Describe the rationale for the review in the context of what
is already known
3-4
Objectives #7 Provide an explicit statement of the question(s) the review
will address with reference to participants, interventions,
comparators, and outcomes (PICO)
4-6
Eligibility criteria #8 Specify the study characteristics (such as PICO, study
design, setting, time frame) and report characteristics (such
as years considered, language, publication status) to be
used as criteria for eligibility for the review
4-6
Information
sources
#9 Describe all intended information sources (such as
electronic databases, contact with study authors, trial
registers or other grey literature sources) with planned
dates of coverage
7
Search strategy #10 Present draft of search strategy to be used for at least one
electronic database, including planned limits, such that it
could be repeated
Appendix
/15
Study records -
data management
#11a Describe the mechanism(s) that will be used to manage
records and data throughout the review
7
Study records -
selection process
#11b State the process that will be used for selecting studies
(such as two independent reviewers) through each phase
of the review (that is, screening, eligibility and inclusion in
meta-analysis)
7
Study records -
data collection
process
#11c Describe planned method of extracting data from reports
(such as piloting forms, done independently, in duplicate),
any processes for obtaining and confirming data from
investigators
7-8
Data items #12 List and define all variables for which data will be sought
(such as PICO items, funding sources), any pre-planned
data assumptions and simplifications
7
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Outcomes and
prioritization
#13 List and define all outcomes for which data will be sought,
including prioritization of main and additional outcomes,
with rationale
5-6
Risk of bias in
individual studies
#14 Describe anticipated methods for assessing risk of bias of
individual studies, including whether this will be done at the
outcome or study level, or both; state how this information
will be used in data synthesis
7-8
Data synthesis #15a Describe criteria under which study data will be
quantitatively synthesised
8-9
#15b If data are appropriate for quantitative synthesis, describe
planned summary measures, methods of handling data and
methods of combining data from studies, including any
planned exploration of consistency (such as I2, Kendall’s τ)
8-9
#15c Describe any proposed additional analyses (such as
sensitivity or subgroup analyses, meta-regression)
10
#15d If quantitative synthesis is not appropriate, describe the
type of summary planned
10
Meta-bias(es) #16 Specify any planned assessment of meta-bias(es) (such as
publication bias across studies, selective reporting within
studies)
10
Confidence in
cumulative
evidence
#17 Describe how the strength of the body of evidence will be
assessed (such as GRADE)
8
The PRISMA-P checklist is distributed under the terms of the Creative Commons Attribution License
CC-BY 4.0. This checklist can be completed online using https://www.goodreports.org/, a tool made
by the EQUATOR Network in collaboration with Penelope.ai
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