WORK PACKAGE 2Sybil Farmer

Venugopal DurairajAnand Pandyan

September 2010

Where are the Gaps?

A framework for development and evaluation of RCTs for complex interventions to improve health MRC 2000

WP2 Activity

• Completion of van Tulder Scoring

• Meeting re Data Extraction

Data Extraction Form• Ref Works ID• Form number• Treatment Regime

– Duration = of course of tx—number FT and unit drop down

– Session duration– Session frequency

• Joint (listed)—yes /no

• Technology --select from drop down list

•  TX Comparisons– AT/AT, – Routine TX/AT,– NoTx/AT, – Sham/AT, other

• Time from end of Tx to last assessment

• Time after Stroke– Under 1 month– 1-6 months ( inclusive of month 6)– Over 6 months – Other

 • Odds ratio data • Effect size data • Study design

Effect Size'Effect size' is simply a way of quantifying the size of the difference between two groups.

Odds Ratio

Compares the proportion of those who benefitted from treatment with the proportion of those in the control group who improved

WP2 Activity

• Completion of van Tulder Scoring

• Meeting re Data Extraction– Webform designed– Level 4 & 3 papers allocated– Data Extracted

• Meeting re Extracted Data

Study DesignsLevel Type of Study Number of

Studies

3Quasi-controlled studies (independent sample design) 33

4

Randomised controlled study design (not powered or powered below 80% and 0.05 significance level)

78

110

Data from78 papers

Effect size 768 lines

Odds Ratio 40 lines

No data from 22 papers

Level 3 & 4 papers

Data Extraction

Data Lines

Selecting Papers

Van Tulder Questions

– Randomisation

– Similar Prognosis

– Assessor Blinded

Gold

Standard

High Quality Papers

52 papersLevel 3&4

38 papersData extracted 32 papers

No data 6 papers

Not Identified as RCTs14 papers

Data extracted 4 papers

Duplicates 3 papers

No data 1 paper

Rejected after checking 6 papers

Yes to Key Questions

Paper Classification

Data Extraction

Papers with Extractable Data

Bio feed-back

CIMT ES Robotics TMS VR0

2

4

6

8

10

12

14

AT Papers

Series1

Shoul

der

Elbo

wS&

E

Wris

t

Hand

Elbo

w, W

rist an

d Han

d

Wris

t & H

and

Arm

Arm&Han

d

0

1

2

3

4

5

6

7

8

Bio feedbackCIMTESRoboticsTMSVR

Joints Treated and ATs

Outcome Measures

• Fugl Myer• ARAT • WMFT• FIM• BPI• Ashworth• Bartel• 9 Hole Peg Test• MAL • Stroke Impact Score• Jebson Taylor Hand

Function

• Force• Distance• ROM

– Active– Passive

• Movement Time

• Repetition• Drawing• Tracking

Outcome Measure, Maximum Effect Size and

ATs

ARAT

Fugl-M

yer

Peak

For

ceMAL

WMFT FI

M

0

0.5

1

1.5

2

2.5

3

Bio feedbackCIMTESRobotics

Where are the Gaps?

A framework for development and evaluation of RCTs for complex interventions to improve health MRC 2000

Timing of Intervention

Bio feed-back

CIMT ES Robotics TMS0

1

2

3

4

5

Mean Time After Stroke

Under 1 Month1-6 MonthsOver 6 Months

Over 6 months ----- mean range 15 -98 months

WP2 Activity

• Completion of van Tulder Scoring

• Meeting re Data Extraction– Webform designed– Level 4 & 3 papers allocated– Data Extracted

• Meeting re Extracted Data

• Papers Cross-checked with Cochrane Reviews

Cochrane Reviews• Electromechanical and robot-assisted arm training for improving arm function

and activities of daily living after stroke

• Electrostimulation for promoting recovery of movement or functional ability after stroke

• Electrical stimulation for preventing and treating post-stroke shoulder pain

• Supportive devices for preventing and treating subluxation of the shoulder after stroke

• Constraint-induced movement therapy for upper extremities in stroke patients

• EMG biofeedback for the recovery of motor function after stroke

• Interventions for sensory impairment in the upper limb after stroke

• Orthotic devices after stroke and other non-progressive brain lesions -Withdrawn

Cochrane Reviews

Bio fe

edba

ckCIM

T ES

Robot

ics TMS VR

0

5

10

15

20

25

30

35

2

129 9

1

4 8

2

3

10

16

2

Cochrane Status

New RejectedIncluded

Papers

Cochrane Protocols• Virtual reality for stroke rehabilitation

• Botulinum toxin for adult spasticity after stroke or non-progressive brain lesion

• Home-based therapy programmes for upper limb functional recovery following stroke

• Hands-on therapy interventions for upper limb motor dysfunction following stroke

• Mental practice for treating upper extremity deficits in individuals with hemiparesis after stroke

• Mirror therapy for improving motor function after stroke• Interventions for maintaining soft tissue length in the stroke –

affected shoulder

WP2 Activity

• Completion of van Tulder Scoring

• Meeting re Data Extraction– Webform designed– Level 4 & 3 papers allocated– Data Extracted

• Meeting re Extracted Data

• Papers Cross-checked with Cochrane Reviews

• Contact with NIHR re development of website

Next Stage

• Write up– Systematic Review Method

• Refine and Test– Quality Assessment Method

• Update– All searches

• Contact Cochrane Stroke Team• Further data exploration and Analysis

More data explorationFOR DISCUSSION

• Improvement maintained at Follow-up?

• How long after 6 Months?

Further Questions?