NIHR Grant NIHR Grant ProgrammeProgramme

RP-PG-0707-10012 RP-PG-0707-10012

Executive Team Meeting Executive Team Meeting

28/9 September 2009 28/9 September 2009

Glanville Centre, Salisbury Glanville Centre, Salisbury District Hospital District Hospital

Development of an Development of an integrated service integrated service

model incorporating model incorporating innovative technology innovative technology for the rehabilitation for the rehabilitation

of the upper limb of the upper limb following stroke following stroke

DDevelopment of an evelopment of an IIntegrated ntegrated SService ervice

model incorporating model incorporating innovative innovative

TTechnology for the echnology for the RRehabilitation of the ehabilitation of the UUpper limb following pper limb following

STSTroke roke

DISTRUSTDISTRUST

Working TitleWorking Title

AAssistive ssistive TTechnolgies echnolgies in the in the RRehabilitation ehabilitation of the of the AArm following rm following

SStroketroke

The The ATRASATRAS project project

www.atrasproject.owww.atrasproject.orgrg

Agenda Agenda 1.00 – 1.301.00 – 1.30 LunchLunch

1.30 – 2.001.30 – 2.00 Project to date Project to date overviewoverview

Ian SwainIan Swain

2.00 – 2.402.00 – 2.40 WP1 progress to dateWP1 progress to date Damian Damian Jenkinson/Gabrielle Mc Jenkinson/Gabrielle Mc HughHugh

2.40 – 3.302.40 – 3.30 WP1 discussion WP1 discussion

3.30 – 3.503.30 – 3.50 CoffeeCoffee

3.50 – 4.303.50 – 4.30 WP2 progress to dateWP2 progress to date Anand Pandyan/Sybil Anand Pandyan/Sybil Farmer Farmer

4.30 – 5.004.30 – 5.00 WP2 discussion WP2 discussion

9.00 - 9.409.00 - 9.40 WP3 progress to dateWP3 progress to date Jane Burridge, Anne-Jane Burridge, Anne-Marie Hughes, Sara Marie Hughes, Sara DemainDemain

9.40 – 9.40 – 10.3010.30

WP3 discussionWP3 discussion

10.30 -10.30 -10.50 10.50

Coffee Coffee

10.50 – 10.50 – 11.1511.15

WP4 decision makingWP4 decision making Ian Swain Ian Swain

11.15- 11.15- 12.0012.00

DiscussionDiscussion

Project Overview Project Overview

• 3 year extension to 5 year 3 year extension to 5 year • Aim: Evidence based clinical service for Aim: Evidence based clinical service for

upper limb rehabilitation following stroke upper limb rehabilitation following stroke over the course of the first year over the course of the first year

• Three Work Packages Three Work Packages – Work Package 1: Determine current UL Work Package 1: Determine current UL

rehabilitation for stroke & outcome measures rehabilitation for stroke & outcome measures used used

– Work Package 2: Literature surveyWork Package 2: Literature survey– Work Package 3: User acceptabilityWork Package 3: User acceptability

• Plan clinical trial and write report at 24 - 27 Plan clinical trial and write report at 24 - 27 monthsmonths

Project TeamProject Team

Project ManagementProject ManagementSalisburySalisburyIan Swain

Jo Regan

WP1 BournemouthWP1 BournemouthDamian Jenkinson

Gabrielle McHughEmma Wood

WP2 KeeleWP2 KeeleAnand Pandyan

Sybil Farmer

WP3 SouthamptonWP3 SouthamptonJane Burridge

Anne Marie HughesSara Domain

StatisticsStatisticsSalisburySalisbury

Paul Strike

Health EconomicsHealth EconomicsSouthamptonSouthamptonDavid TurnerJames Raftery

Project Team 2Project Team 2• Salisbury Salisbury

– Duncan Wood, Paul Taylor, Geraldine Mann, (Stef Scott R&D Duncan Wood, Paul Taylor, Geraldine Mann, (Stef Scott R&D advice)advice)

• GloucesterGloucester – Frank HarsentFrank Harsent

• NottinghamNottingham– Hywel Williams, Diane WhithamHywel Williams, Diane Whitham

• OswestryOswestry– Neil PostansNeil Postans

• SouthamptonSouthampton– Caroline Ellis-Hill, Paul Chappell, Lucy YardleyCaroline Ellis-Hill, Paul Chappell, Lucy Yardley

• NewcastleNewcastle– Garth Johnson, Paul CharltonGarth Johnson, Paul Charlton

• Stoke Stoke – Tony Ward, Alexandra BallTony Ward, Alexandra Ball

• Birmingham (WP4)Birmingham (WP4)– Christine Singleton Christine Singleton

Overview 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 How do we decide which ATs to incorporate in the clinical trialincorporate in the clinical trial ??

• Key Question 2Key Question 2

– How soon can we submit the Interim How soon can we submit the Interim report?report?

• Key Question 3Key Question 3

– How quickly do we get an answer from How quickly do we get an answer from NIHR after submitting the interim NIHR after submitting the interim report?report?

NIHR PROGRAMME GRANT v3 09       10       11      

Version 2 if trial not funded                  

Start date 1/3/09 (Q1) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

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/

1001/03/

11    20/11/

10

WP2 - Literature review09Q1 Q2 Q3 Q4

10Q1 Q2 Q3 Q4

11Q1 Q2 Q3 Q4

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      20/11/2009      

20/11/2010

01/03/2011    

20/11/2010

WP3 - Acceptability of ATs09Q1 Q2 Q3 Q4

10Q1 Q2 Q3 Q4

11Q1 Q2 Q3 Q4

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      20/11/2009      

20/11/2010

01/03/2011    

20/11/2010

WP4 - Clinical Trials09Q1 Q2 Q3 Q4

10Q1 Q2 Q3 Q4

11Q1 Q2 Q3

Q4/Q1 2012

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      01/03/2010  

01/09/2010

01/03/2011    

01/03/2012

Trial design report (major report)                15/03/2

011      

Presenting at key meetings                        

Writing final report                        

Publishing book/special edition                        

International conference                        

Definition of ATsDefinition of ATsAn AT is a mechanical or electrical device An AT is a mechanical or electrical device

used in a functional task orientated used in a functional task orientated training process which will have a training process which will have a

systemic or rehabilitative effect on the systemic or rehabilitative effect on the person. This specifically excludes devices person. This specifically excludes devices used to improve a single function such as a used to improve a single function such as a

modified spoon, dressing aid etc.modified spoon, dressing aid etc.It is possible that the evidence will be It is possible that the evidence will be stronger for an AT which his used in stronger for an AT which his used in

conjunction with another treatment such conjunction with another treatment such as a drug treatment eg Botulinum or as a drug treatment eg Botulinum or physiotherapy. If so that combined physiotherapy. If so that combined

package will be considered as ‘The AT’ to package will be considered as ‘The AT’ to go forward as one arm of the clinical trial. go forward as one arm of the clinical trial.

We will not consider treatments that do We will not consider treatments that do not include a device. not include a device.

What can be usedWhat can be used

• Rehabilitation RobotsRehabilitation Robots• Functional Electrical StimulationFunctional Electrical Stimulation• EMG BiofeedbackEMG Biofeedback• Active OrthoticsActive Orthotics• Constraint Induced Movement Constraint Induced Movement

TherapyTherapy• Combinations of the above Combinations of the above

– Including use of current treatments Including use of current treatments • Physio, passive splinting, botulinum toxinPhysio, passive splinting, botulinum toxin

Key Deadlines Key Deadlines

• 3 months delay by DOH 3 months delay by DOH – Start date 1/3/09Start date 1/3/09

• 12 months: Financial Reporting 12 months: Financial Reporting – 1/3/101/3/10

• 18 months: Progress Report to NIHR18 months: Progress Report to NIHR– 1/9/101/9/10

• 24 months: Interim Project report24 months: Interim Project report– 1/3/111/3/11

• Determines whether clinical trial continues Determines whether clinical trial continues • Submitted to NIHR at the end of Year 2 Submitted to NIHR at the end of Year 2

ATRAS Web siteATRAS Web site

• https://portal.nihr.ac.uk/sites/nihr-ccf/ATRAS/Pages/Description.aspx

Steering CommitteeSteering Committee

• Rhodda Alison – Devon PCTRhodda Alison – Devon PCT• Prof Anne Ashburn – Southampton UniversityProf Anne Ashburn – Southampton University• Stephen Little/Debbie Wilson – Different Stephen Little/Debbie Wilson – Different

StrokesStrokes• 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 Dr. Paulette van Vliet – Nottingham

University University

Suggestions/Comments Suggestions/Comments from the Steering from the Steering

CommitteeCommittee• Contact Val Pomeroy to utilise her work on Contact Val Pomeroy to utilise her work on

current treatmentscurrent treatments• ICF Guidelines should be used for classifying ICF Guidelines should be used for classifying

evidence in WP2evidence in WP2• Revise project plan to allow sufficient time for Revise project plan to allow sufficient time for

producing the Trial Design Report (1/3/11)producing the Trial Design Report (1/3/11)• Employ Prof Maarten Ijzerman as a consultant Employ Prof Maarten Ijzerman as a consultant

to help with decision making for WP4to help with decision making for WP4• Is 2 years going to be long enough for the Is 2 years going to be long enough for the

clinical trial?clinical trial?

To do in near futureTo do in near future

• WP3 interactive exhibition 7-9 WP3 interactive exhibition 7-9 October, Southampton University 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

www.atrasprojewww.atrasproject.orgct.org