Trial of Wii TM in Stroke- TWIST

Trial of Wii TM in Stroke- TWIST

NIHR Statement This presentation summarises independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) programme. (Grant reference: PB-PG-0110-20332) The views expressed in this publication are those of the authors and not necessarily those of the NHS, NIHR or Department of Health. Trial registered with ISRCTN 06807619 and UK CRN 11030.

Rationale for TWIST 70% arm weakness post stroke 1 Physical therapy: evidence for high intensity, repetitive and task specific training 2 50% of patients do not get PT needed 31% of patients do not adhere to exercises 4 1.Royal College of Physicians. National Clinical Guideline for Stroke. Royal College of Physicians. 2012. 2.Langhorn P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurology. 2009;8:741-54. 3.Shaugnessy M, Resnick B, Macko R. Testing a model of post-stroke exercise behaviour. Rehabilitation Nursing. 2006;21(1):15-21. 4.Royal College of Physicians. Sentinel Stroke National Audit Programme (SSNAP). Clinical audit first pilot report. 2013.

Virtual Reality (VR) and Arm Function after Stroke Systematic review 2014: 24 RCTs (N = 626) 4 Significant effect for body functions and activity for VR therapy compared to conventional therapy VR rehabilitation moderately improves outcomes in adults post stroke 1 trial using Nintendo Wii TM Sports for upper limb rehab: N=18, no adverse side effects, improvement on WMF mean motor function (7s) 5 4. Lohse KR, Hilderman CGE, Cheung KL, Tatla S, Van der Loos HFM. Virtual Reality Therapy for Adults Post-Stroke: A Systematic Review and Meta-Analysis Exploring Virtual Environments and Commercial Games in Therapy. PLOS ONE 2014; 9 (3): 1-13.

Design of TWIST 1. RCT (single-blinded, 10 centres) Primary objective: Does six weeks of daily Wii TM Sports exercise improve arm function after stroke in comparison arm exercises, both at home? Secondary objectives: Arm function at 6 months, Occupational performance, Quality of Life, Adverse effects 2. Qualitative study Factors that influence use of Wii TM for participants and carers in practice? 3. Cost Effectiveness Analysis

Intervention Wii TM sports games of participants choice for 6 weeks in seated position up to 45 minutes per day at home Control Participant tailored arm exercise for 6 weeks in seated position up to 45 minutes per day Both groups continued usual therapy and were followed up at 6 week and 6 months

Outcome measures RCT Primary Outcome Measure: Action Research Arm Test Secondary Outcome Measures Canadian Occupational Performance Measure Stroke Impact Scale EQ 5D Motor Activity Log (6 month only) Baseline data: stroke severity, impairment, arm strength, demographic data, use of Wii TM

Inclusion Criteria New stroke within last 6 months Aged 18 years or older Living in suitable environment Weakness in affected arm (MRC<5 in any joint plane of movement) due to stroke Exclusion Criteria Co-morbidities which impair ability to participate Symptomatic Shoulder Subluxation Pacemaker or ICD device Consideration of other interventional studies in line with Stroke Research Network guidance Able to manipulate Wii TM control remote Able to understand and follow 2 stage commands and give written or verbal consent

Flow Through study Informed consent Baseline visit by research practitioner Randomisation and Set up visit by research therapist Intervention period - diaries, phone call by administrator 6 week research therapist collection visit 6 week research practitioner assessment visit 6 months research practitioner assessment visit Qualitative study after 6 week visit

Analysis Main RCT, groups stratified by ARAT, previous use of Wii TM and centre allocation Primary outcome ARAT analysis of covariance Minimum of 99 participants per group, 80% power, with 5% type one error and two-sided significance test Health Economics analysis- QALYs, annuitised cost of Wii TM over 3 years, therapy standard costs Qualitative study-thematic analysis

Participant numbers 6027 participants screened 338 met inclusion criteria (5.6%) 98 declined to participate (29%) 235 participants randomised 209 completed all 3 study visits

Baseline Characteristics Characteristics Wii TM Group N=117 Control Group N=118 Age, years 66.9 68.0 Right handed % 87.2 88.1 Female % 43.6 44.9 Non smoker % 33.3 33.9 In employment % 28.2 22.9 Stroke to randomisation, d 57.3 77.0 Previous use of Wii TM % 42.7 42.4 Ischaemic stroke % 88.9 89 TACS % 8.6 11.9 MRS slight disability % 42.7 43.2 ARAT baseline, mean 41.2 41.0 EQ 5D VAS 63.6 61.1

Result Primary Outcome - ARAT ARAT mean Wii TM Group Control Group Mean Difference 95% CI P value Baseline 41.2 41.0 Six weeks 47.6 49.0-1.7-3.9 to 0.5 0.12 Six Months 49.5 49.3-0.4-3.2 to 2.4 0.79

Secondary Outcome MAL - 6 month Outcome Mean MAL Amount of use MAL Quality of Movement Wii TM Control Mean Diff 95% CI P value 2.9 3.2-0.34-0.76 to 0.07 0.099 2.8 3.0-0.35 0.74 to 0.076 0.076

Secondary Outcomes 6 months Outcome Mean Wii TM Control Mean Diff 95% CI P value SIS 670 684-21 -52 to 11 0.19 COPM Performance COPM Satisfaction EQ 5D VAS 28.8 29.4-0.2-3.3 to 3.0 0.91 30.3 31.5-0.2-3.4 to 3.0 0.90 70.8 70.9-1.2-6.0 to 3.7 0.63

Safety 46 serious adverse events (SAEs) None were treatment related 13 were readmission with recurrent stroke event 22 admissions to hospital for other reasons (myocardial infarction, fast atrial fibrillation, urosepsis, cellulitis, fall, pacemaker insertion and fractures) 11 other significant medical events

Exercise Time Outcome Mean N of days completed 0 0-20 21-42 Wii TM Control P value 14 40 63 16 13 89 0.001 Minutes of exercise per day 37.3 (14.3) 31.7 (16.1) 0.009 Total amount of exercise 1020 (721) 998 (554) 0.805

Cost effectiveness analysis Outcome in Mean (SD) Wii TM Control NIHS costs 660 (848) 495 (377) Social Care Package Cost 317 (1218) 207 (641) Aids and appliances 18 (87) 28 (105) Wii TM cost 112 - Total 1106 (1656) 730 (829) QALY in years 0.327 (0.115) 0.333 (0.101)

Conclusions: Wii Sports TM Improved arm function at 6 weeks but not superior to arm exercises in our study group No serious adverse events Well tolerated by participants More costly than arm exercises Limitations of study: Blinding of researchers and participants Relatively young study group ARAT ceiling effect Duration of exercise

Acknowledgments Participating centres National Institute for Health Research Ethics Committee Royal Cornwall Hospitals NHS Trust (Sponsor) PenCTU (Plymouth University) Statistician Janet Freeman South West Stroke Research Network Research and Design Service South West Centre North Devon 15 2012 Trial Steering Committee: Prof Jane Burridge, Prof Helen Rodgers, Dr Martin James, Dr Rhoda Allison, Colin Pritchard, Dr Obioha Ukoumunne, Chris Cannaby, Jacqueline Briggs, Anne Shirley, John Humfryes Recruited Cornwall 101 Plymouth 38 Torbay 18 Exeter 17 Taunton 11 Yeovil 17 Dorchester 8 Sheffield 7 Portsmouth 8

Literature 1. Royal College of Physicians. National Clinical Guideline for Stroke. Royal College of Physicians. 2012. 2. Langhorn P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurology. 2009;8:741-54. 3. Shaugnessy M, Resnick B, Macko R. Testing a model of post-stroke exercise behaviour. Rehabilitation Nursing. 2006;21(1):15-21. 4. Royal College of Physicians. Sentinel Stroke National Audit Programme (SSNAP). Clinical audit first pilot report. 2013 5. Lohse KR, Hilderman CGE, Cheung KL, Tatla S, Van der Loos HFM. Virtual Reality Therapy for Adults Post-Stroke: A Systematic Review and Meta-Analysis Exploring Virtual Environments and Commercial Games in Therapy. PLOS ONE 2014; 9 (3): 1-13. 6. Saposnik G, Teasell R, Mamdani M, Hall J, McIlry W, Cheung D, Thorpe KE, Cohen LG, Bayley M.. Effectiveness of Virtual Reality Using Wii Gaming Technology in Stroke Rehabilitation: A Pilot Randomised Clinical Trial and Proof of Principle. Stroke. 2010;41:1477-1484.

Qualitative study Factors that influenced the use Wii Purposive sample 18 participants and 10 caregivers Age range 35-84, mean age 62, 11 male MRS: 8 mild (1-2) and 10 (3) moderate disability 14 had no experience of using the Wii TM prior to study Use of Wii Sports TM for most participants acceptable form of arm rehabilitation Factors that influence use of Wii TM Flexibility of rehabilitation at home Time frame for rehabilitation Fun, engagement and feedback from game Administration and set up

Secondary Outcomes 6 weeks Outcome Mean Wii TM Control Mean Diff 95% CI P value SIS 670 684-21 -52 to 11 0.19 COPM Performance COPM Satisfaction EQ 5D VAS 28.8 29.4-0.2-3.3 to 3.0 0.91 30.3 31.5-0.2-3.4 to 3.0 0.90 70.8 70.9-1.2-6.0 to 3.7 0.63