28/11/2011

1

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

28/11/2011

2

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

28/11/2011

3

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

28/11/2011

4

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

28/11/2011

5

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

28/11/2011

6

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

28/11/2011

7

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