NIHR Grant Programme RP-PG Executive Team Meeting 28/9 September 2009 Glanville Centre, Salisbury District Hospital

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 project

Agenda 1.00 – 1.30 Lunch 1.30 – 2.00 Project to date overview Ian Swain 2.00 – 2.40 WP1 progress to date Damian Jenkinson/Gabrielle Mc Hugh 2.40 – 3.30 WP1 discussion 3.30 – 3.50 Coffee 3.50 – 4.30 WP2 progress to date Anand Pandyan/Sybil Farmer 4.30 – 5.00 WP2 discussion WP3 progress to date Jane Burridge, Anne-Marie Hughes, Sara Demain 9.40 – WP3 discussion Coffee – WP4 decision making Ian Swain Discussion

Project Overview 3 year extension to 5 year3 year extension to 5 year Aim: Evidence based clinical service for upper limb rehabilitation following stroke over the course of the first yearAim: Evidence based clinical service for upper limb rehabilitation following stroke over the course of the first year Three Work PackagesThree Work Packages –Work Package 1: Determine current UL rehabilitation for stroke & outcome measures used –Work Package 2: Literature survey –Work Package 3: User acceptability Plan clinical trial and write report at monthsPlan clinical trial and write report at months

Project Team StatisticsSalisbury Paul Strike Health Economics Southampton David Turner James Raftery

Project Team 2 SalisburySalisbury – Duncan Wood, Paul Taylor, Geraldine Mann, (Stef Scott R&D advice) GloucesterGloucester –Frank Harsent NottinghamNottingham –Hywel Williams, Diane Whitham OswestryOswestry –Neil Postans SouthamptonSouthampton –Caroline Ellis-Hill, Paul Chappell, Lucy Yardley NewcastleNewcastle –Garth Johnson, Paul Charlton StokeStoke –Tony Ward, Alexandra Ball Birmingham (WP4)Birmingham (WP4) –Christine Singleton

Overview How each package contributes to the end result…How each package contributes to the end result… Key Question 1Key Question 1 –How do we decide which ATs to incorporate in the clinical trial ? Key Question 2Key Question 2 –How soon can we submit the Interim report? Key Question 3Key Question 3 –How quickly do we get an answer from NIHR after submitting the interim report?

NIHR PROGRAMME GRANT v Version 2 if trial not funded Start date 1/3/09 (Q1) Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4 Task WP1 - Review of existing services Identification of centres Qualitative design phase workshop Drafting of questionnaire Piloting of questionnaire Analysis of pilot results Modification of questionnaire Main questionnaire and follow up Analysis of results Producing review for publication Updating existing services review Reports 20/11/ 09 20/11/ 10 01/03/ 11 20/11/ 10

WP2 - Literature review 09 Q1Q2Q3Q4 10 Q1Q2Q3Q4 11 Q1Q2Q3Q4 Planning the review Conducting the searches Selection of articles Review process Peer review by management team Audit of article selection Audit of reviewed articles Updating of reviews Publication of systematic reviews Reports 20/11/ /11/ /03/ /11/ 2010

WP3 - Acceptability of ATs 09 Q1Q2Q3Q4 10 Q1Q2Q3Q4 11 Q1Q2Q3Q4 Ethical application and approval Design, running and evaluating the interactive exhibition Focus groups Focus group analysis Questionnaire design Questionnaire validation Questionnaire data collection Questionnaire analysis Field trials design Dissemination Reports 20/11/ /11/ /03/ /11/ 2010

WP4 - Clinical Trials 09 Q1Q2Q3Q4 10 Q1Q2Q3Q4 11 Q1Q2Q3 Q4/Q WP4 Phase 1 AT selection procedure and consultation Decision on what ATs to include in Phase 2 Trial design WP4 Phase 2 JDs and advert for therapists WP6 - Dissemination Annual/Financial Report 01/03/ /09 / /03/ /03/ 2012 Trial design report (major report) 15/03/2 011 Presenting at key meetings Writing final report Publishing book/special edition International conference

Definition of ATs An AT is a mechanical or electrical device used in a functional task orientated training process which will have a systemic or rehabilitative effect on the person. This specifically excludes devices used to improve a single function such as a modified spoon, dressing aid etc. It is possible that the evidence will be stronger for an AT which his used in conjunction with another treatment such as a drug treatment eg Botulinum or physiotherapy. If so that combined package will be considered as ‘The AT’ to go forward as one arm of the clinical trial. We will not consider treatments that do not include a device.

What can be used Rehabilitation RobotsRehabilitation Robots Functional Electrical StimulationFunctional Electrical Stimulation EMG BiofeedbackEMG Biofeedback Active OrthoticsActive Orthotics Constraint Induced Movement TherapyConstraint Induced Movement Therapy Combinations of the aboveCombinations of the above –Including use of current treatments Physio, passive splinting, botulinum toxinPhysio, passive splinting, botulinum toxin

Key Deadlines 3 months delay by DOH3 months delay by DOH –Start date 1/3/09 12 months: Financial Reporting12 months: Financial Reporting –1/3/10 18 months: Progress Report to NIHR18 months: Progress Report to NIHR –1/9/10 24 months: Interim Project report24 months: Interim Project report –1/3/11 Determines whether clinical trial continuesDetermines whether clinical trial continues Submitted to NIHR at the end of Year 2Submitted to NIHR at the end of Year 2

ATRAS Web site ccf/ATRAS/Pages/Description.aspxhttps://portal.nihr.ac.uk/sites/nihr- ccf/ATRAS/Pages/Description.aspxhttps://portal.nihr.ac.uk/sites/nihr- ccf/ATRAS/Pages/Description.aspxhttps://portal.nihr.ac.uk/sites/nihr- ccf/ATRAS/Pages/Description.aspx

Steering Committee Rhodda Alison – Devon PCTRhodda Alison – Devon PCT Prof Anne Ashburn – Southampton UniversityProf Anne Ashburn – Southampton University Stephen Little/Debbie Wilson – Different StrokesStephen Little/Debbie Wilson – Different Strokes Dr. John Chae – Cleveland OhioDr. John Chae – Cleveland Ohio Prof Herme Hermans – Het Roessingh NEProf Herme Hermans – Het Roessingh NE Stephanie Armstrong - Stroke AssociationStephanie Armstrong - Stroke Association Dr Chris Price – Newcastle NHSDr Chris Price – Newcastle NHS Dr. Paulette van Vliet – Nottingham UniversityDr. Paulette van Vliet – Nottingham University

Suggestions/Comments from the Steering Committee Contact Val Pomeroy to utilise her work on current treatmentsContact Val Pomeroy to utilise her work on current treatments ICF Guidelines should be used for classifying evidence in WP2ICF Guidelines should be used for classifying evidence in WP2 Revise project plan to allow sufficient time for producing the Trial Design Report (1/3/11)Revise project plan to allow sufficient time for producing the Trial Design Report (1/3/11) Employ Prof Maarten Ijzerman as a consultant to help with decision making for WP4Employ Prof Maarten Ijzerman as a consultant to help with decision making for WP4 Is 2 years going to be long enough for the clinical trial?Is 2 years going to be long enough for the clinical trial?

To do in near future WP3 interactive exhibition 7-9 October, Southampton UniversityWP3 interactive exhibition 7-9 October, Southampton University Stroke Forum – workshop and posterStroke Forum – workshop and poster Financial report 1/3/10Financial report 1/3/10 Project progress form 1/9/10Project progress form 1/9/10 DONM end of March 2010DONM end of March 2010