Loss of upper limb function affects up to 85 % of acutestroke patients. Recovery of upper limb function requires regular intensivepractise of specific upper limb tasks. To enhance intensity of practiceinterventions are being developed to encourage patients to undertakeself-directed exercise practice. Most interventions do not translate well intoeveryday activities and stroke patients continue to find it difficultremembering integration of upper limb movements into daily activities. Awrist-worn device has been developed that monitors and provides ‘live’ upperlimb activity feedback to remind patients to use their stroke arm in dailyactivities (The CueS wristband). The aim of this trial is to assess thefeasibility of a multi-centre, observer blind, pilot randomised controlledtrial of the CueS wristband in clinical stroke services.
This pilot randomised controlled feasibility trial aims torecruit 60 participants over 15 months from North East England.Participants will be within 3 months of stroke which has caused newreduced upper limb function and will still be receiving therapy. Eachparticipant will be randomised to an intervention or control group.Intervention participants will wear a CueS wristband (between 8 am and8 pm) providing “live” feedback towards pre-set movement goals through asimple visual display and vibration prompts whilst undertaking a 4-week upperlimb therapy programme (reviewed twice weekly by an occupational/physiotherapist).Control participants will also complete the 4-week upper limb therapy programmebut will wear a ‘sham’ CueS wristband that monitors upper limb activity butprovides no feedback. Outcomes will determine study feasibility in terms ofrecruitment, retention, adverse events, adherence and collection of descriptiveclinical and accelerometer motor performance data at baseline, 4 weeks and8 weeks.
The WAVES study will address an important gap in theevidence base by reporting the feasibility of undertaking an evaluation ofemerging and affordable technology to encourage impaired upper limb activityafter stroke. The study will establish whether the study protocol can besupported by clinical stroke services, thereby informing the design of a futuremulti-centre randomised controlled trial of clinical and cost-effectiveness.
ISRCTN:82306027.Registered 12 July 2016.
- stroke, upper limb, accelerometer, feedback, self-management, self-directed, rehabilitation, randomised controlled trial