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DISTRUST - kt-equal.org.ukkt-equal.org.uk/uploads/Stroke_Ian Swain.pdf · • Biofeedback •...
Transcript of DISTRUST - kt-equal.org.ukkt-equal.org.uk/uploads/Stroke_Ian Swain.pdf · • Biofeedback •...
28/11/2011
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The evidence for the use of technology in the rehabilitation
of the arm post stroke
Ian SwainNIHR Grant Programme
RP-PG-0707-10012
23rd November 2011 Salisbury NHS Foundation Trust
Bournemouth University
Development of an integrated service model incorporating innovative
technology for the rehabilitation of the upper
limb following stroke
Development of an Integrated Service model incorporating innovative
Technology for the Rehabilitation of the Upper
limb following STroke
DISTRUST
Working Title
Assistive Technolgies in the Rehabilitation of the Arm
following Stroke
The ATRAS projectwww.atrasproject.org
Project Overview • Originally a 3 year grant with an extension to 5 years • Aim: Evidence based clinical service for upper limb
rehabilitation following stroke over the course of the first year
• Three Work Packages – Work Package 1: Determine current UL rehabilitation for
stroke & outcome measures used from both patient and professional perspectives
– Work Package 2: Literature survey and systematic reviews– Work Package 3: User acceptability for clinicians, patients,
carers and commissioners• Plan clinical trial WP4 – applying to HTA
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Project Team
Project ManagementSalisburyIan Swain
Jo Regan
WP1 BournemouthDamian Jenkinson
Gabrielle McHugh
WP2 KeeleAnand Pandyan
Sybil Farmer
WP3 SouthamptonJane Burridge
Ruth TurkAnne Marie Hughes
Sara Domain
Statistics
Paul StrikePeter Thomas
Health EconomicsSouthamptonDavid TurnerJames Raftery
Project Team 2• Salisbury
– Duncan Wood, Paul Taylor, Geraldine Mann, (Stef Scott R&D advice)
• Gloucester– Frank Harsent
• Nottingham– Jim Thornton, Diane Whitham
• Oswestry– Neil Postans
• Southampton– Caroline Ellis-Hill, Paul Chappell, Lucy Yardley
• Newcastle– Garth Johnson, Paul Charlton
• Stoke – Tony Ward
Overview
• How each package contributes to the end result…
• Key Question
How do we decide which ATs to incorporate in the clinical trial ?
What can be used• Rehabilitation Robots• Functional Electrical Stimulation• Cortical Stimulation• Biofeedback• Active Orthotics• Constraint Induced Movement Therapy• VR including Wii• Combinations of the above
– Including use of current treatments, but not as primary treatments
• e.g. Physio, passive splinting, botulinum toxin
Rehabilitation Robots
Functional Electrical Stimulation
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Biofeedback and VR
Active Orthotics
Constraint Induced Movement Therapy
Steering Committee
• Rhodda Alison – Devon PCT• Prof Anne Ashburn – Southampton University• Debbie Wilson – Different Strokes• Dr. John Chae – Cleveland Ohio• Prof Herme Hermans – Het Roessingh NE• Stephanie Armstrong - Stroke Association• Dr Chris Price – Newcastle NHS• Dr. Paulette van Vliet – Nottingham University• Stephen Little – Patient Representative (DS)
How do we decide which trial to conduct
• Scientific published evidence meeting WP2 criteria
• Patient and user acceptability• Cost effective• Use of objective measures such as AHP• Able to have a trial designed in practice
– i.e. sample size calculations– Practical in a clinical setting
AHP process
• Seminars and workshops given by Maarten Ijzerman• Its been used in Healthcare for the last 10 years• Combines clinical experience with systematic reviews.• Define attributes, both primary and secondary and
assign attribute weights to them– Can be done both by professionals and patients
• Identify alternative treatments• Undertake comparisons in order to get performance
weights.• Done using Expert Choice software
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Choosing the Best Restaurant
Restaurant 1Thai
Restaurant 2Burger Bar
Style Price Style Price
0.56+0.09 = 0.65 0.28+0.24 = 0.52
Alternatives
Attribute Weights
Criteria
PerformanceScores
Outcomes
0.7 0.3 0.7 0.3
0.8 0.3 0.4 0.8
Attributes and Attribute WeightsDetermined by Exec team in March and confirmed with
Steering Committee, also to be completed by patients via WP3 as these give different answers
• Function• Comfort• Risks
– Short term– Long term
• Daily effort (patient)– Time – Complexity
• Impact on Health Service– Time– Complexity
Attribute Weights Voting
WP1 – Survey of Current Practice
• Phase 1 – Advisory group (May 2009)• Phase 2 – Workshop (July 2009)• Phase 3 – Pilot • Phase 4 – National distribution
– 20 out of 28 Stroke Networks, over 15800 patients
– Service providers, and patients perceptions on the suggestion of the Steering Committee
0 2 4 6 8 10 12 14 16
Acute SU
Combined SU
Outpts/Day Hospital
ResidCare
S Rehab U
Neur RU
Comm HC
Home/Stroke Care
Private
ESD
Teams Identified
0 5 10 15 20 25 30 35 40 45 50 55 60 65
Unsupervised ex.progStretches
Active Exer/physio/chair-basedfacilitated/passive movement
Home excercisecarer training
Functional Activities/ADLsPosture& Positioning/ support
core stability/weightbearingsoft tissue mobilization/oedema management
Odema ManagementFine Motor skill
Reach/graspTask specific repetitions
Bilateral trainingSensory stimulation/reeducation
Proprioceptionstereognosis
Mental Imagerymirror trainingstrengthening
Constraint Induced therapypatient training
splintingTaping
ESSaeboflex
BotoxPain Management/control
BiometricsWii
Robot
Treatment
Patient A
Patient B
Patient C
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0 5 10 15 20 25 30 35 40 45 50 55 60 65
Unsupervised ex.progStretches
Active Exer/physio/chair-basedfacilitated/passive movement
Home excercisecarer training
Functional Activities/ADLsPosture& Positioning/ support
core stability/weightbearingsoft tissue mobilization/oedema management
Odema ManagementFine Motor skill
Reach/graspTask specific repetitions
Bilateral trainingSensory stimulation/reeducation
Proprioceptionstereognosis
Mental Imagerymirror trainingstrengthening
Constraint Induced therapypatient training
splintingTaping
ESSaeboflex
BotoxPain Management/control
BiometricsWii
Robot
Treatment
Patient A
Patient B
Patient C
-5 5 15 25 35 45
AROMPROM
Muscle PowerCo-ordination
SensationTone
Fine Motor SkillProprioception
StereognosisFunctional Activities
PainMAS
Oxford GradingBartel
Nottingham Sensory…VAS
Goal AchievementAshworth Scale
9holepeg
Assessments
End of TreatmentAssessments
Start of TreatmentAssessments
WP2 Search results
763763Screening checked by
2nd reviewer
24242424Titles found
464464Accepted
80 Review papers
299Rejected
299Rejected
1361Failed
selection criteria
384 Research papers
Selecting Papers Bias Free PapersVan Tulder Questions
– Randomisation
– Similar Prognosis
– Assessor Blinded
Gold
Standard
Less than 25% of studies considered in Cochrane reviews
36.04 35.85 36.1234.53
30.19
36.56
22.5220.75
23.35
0.00
5.00
10.00
15.00
20.00
25.00
30.00
35.00
40.00
Total Before 2005 After 2005
% of P
aper
s
Percentage of Papers with Subjects Randomised and /or with Assessors
Blinded to Treatment
Papers with Subjects Randomised
Papers with Assessor Blinded to Treatment
Papers with Subjects Randomised and Assessors Blinded to Treatment
Experimental Papers – Quality needs improvement
Cochrane Reviews1. Electromechanical and robot-assisted arm training for improving arm
function and activities of daily living after stroke2. Electrostimulation for promoting recovery of movement or functional
ability after stroke3. Electrical stimulation for preventing and treating post-stroke shoulder pain4. Supportive devices for preventing and treating subluxation of the shoulder
after stroke5. Constraint-induced movement therapy for upper extremities in stroke
patients6. EMG biofeedback for the recovery of motor function after stroke7. Virtual reality for stroke rehabilitation
No Assistive Technologies Recommended
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Published Evidence- of the relevant quality
• Biofeedback 4• CIMT 8• ES 14• Robotics 7• TMS 1• VR none• Active orthotics none
Effect size is a function of time post stroke – is this working against AT?
- ES papers
WP3 Methods for accessing user needs
• Exhibition held for professionals, patients and carers – Three days
• Focus groups completed– HCPs, patients, carers, commissioners
• Main questionnaire has been sent out– Includes same questions as AHP collected from
professionals
What patients say:
• We prefer to learn through doing rather than exercises
• We want to do it at home• No more than 2 minutes setting it up• It MUST be reliable and easy to use• It must be designed for specific needs
What the clinicians say:
• It must be cheap and available• Evidence based• Consider training requirements• It must be applicable to a wide range of patients
BUT be able to be personalised• They re-iterate what the patients say
What we have learnt from WP 3- summary
• Self management is key – locus of control: – Motivation – enjoyable, clear benefit and designed to
achieve realistic goals– Adherence– Intensity
• If patients reach a level of ability that allows near normal use then benefits are more likely to be maintained
• Intelligent progression of tasks and activities
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Initial thoughts for the Trial
• FES and CIMT have the greatest evidence.• FES best in acute phase• CIMT usually used when people have 10 degrees
of wrist extension• Therefore have a two stage trial with
randomisation to FES/control in acute phase then see how many reach CIMT criteria
• Randomise both these two groups to CIMT and control separately
Problems with this Trial
• Patients don’t like CIMT• How many people reach CIMT criteria• What proportion of the stroke population does this
represent• At what time in their rehab do they reach the CIMT
criteria• Therefore how many people of do we initially need to
recruit in order to power the complete trial
What was needed
• Of all the technologies only ES is applicable to use in the acute phase
• Evidence for ES indicated that the earlier the use the better
• No history available of the natural recovery of arm function post stroke
• Therefore the proposed trial was to look at – RCT to determine ES in suitable patients– Longitudinal study in a wider cohort to determine natural
recovery and the numbers of patients suitable for other ATs
What now ?
• Looking to HTA to find a Phase III RCT of ES in acute stroke on suggestion of NIHR
• Seeking additional funding to undertake longitudinal study
• Funding also being sought to look in more detail in the patients perspective of the current treatment they receive. (WP1)
www.atrasproject.org
•This presentation 23/11/11 presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (RP-PG-0707-10012). The views expressed in this presentation 23/11/11 are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health
www.atrasproject.org