title: Wristband Accelerometers to motiVate arm Exercise after Stroke (WAVES): study protocol for a pilot randomized controlled trial.
abstract: Loss of upper limb function affects up to 85 % of acute stroke patients. Recovery of upper limb function requires regular intensive practise of specific upper limb tasks. To enhance intensity of practice interventions are being developed to encourage patients to undertake self-directed exercise practice. Most interventions do not translate well into everyday activities and stroke patients continue to find it difficult remembering integration of upper limb movements into daily activities. A wrist-worn device has been developed that monitors and provides 'live' upper limb activity feedback to remind patients to use their stroke arm in daily activities (The CueS wristband). The aim of this trial is to assess the feasibility of a multi-centre, observer blind, pilot randomised controlled trial of the CueS wristband in clinical stroke services.
  
  
  
  This pilot randomised controlled feasibility trial aims to recruit 60 participants over 15 months from North East England. Participants will be within 3 months of stroke which has caused new reduced upper limb function and will still be receiving therapy. Each participant will be randomised to an intervention or control group. Intervention participants will wear a CueS wristband (between 8 am and 8 pm) providing "live" feedback towards pre-set movement goals through a simple visual display and vibration prompts whilst undertaking a 4-week upper limb therapy programme (reviewed twice weekly by an occupational/physiotherapist). Control participants will also complete the 4-week upper limb therapy programme but will wear a 'sham' CueS wristband that monitors upper limb activity but provides no feedback. Outcomes will determine study feasibility in terms of recruitment, retention, adverse events, adherence and collection of descriptive clinical and accelerometer motor performance data at baseline, 4 weeks and 8 weeks.
  
  
  
  The WAVES study will address an important gap in the evidence base by reporting the feasibility of undertaking an evaluation of emerging and affordable technology to encourage impaired upper limb activity after stroke. The study will establish whether the study protocol can be supported by clinical stroke services, thereby informing the design of a future multi-centre randomised controlled trial of clinical and cost-effectiveness.
  
  
  
  ISRCTN:82306027 . Registered 12 July 2016.
authors: Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK.
authors: Sarah A
authors: SA
authors: Moore
authors: Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK.
authors: Ruth
authors: R
authors: Da Silva
authors: School of Computing Science (Open Lab), Newcastle University, Newcastle upon Tyne, NE1 7RU, England, UK.
authors: Madelaine
authors: M
authors: Balaam
authors: Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK.
authors: Lianne
authors: L
authors: Brkic
authors: School of Computing Science (Open Lab), Newcastle University, Newcastle upon Tyne, NE1 7RU, England, UK.
authors: Dan
authors: D
authors: Jackson
authors: School of Computing Science (Open Lab), Newcastle University, Newcastle upon Tyne, NE1 7RU, England, UK.
authors: Dan
authors: D
authors: Jamieson
authors: School of Computing Science (Open Lab), Newcastle University, Newcastle upon Tyne, NE1 7RU, England, UK.
authors: Thomas
authors: T
authors: Ploetz
authors: Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK.
authors: Helen
authors: H
authors: Rodgers
authors: Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK.
authors: Lisa
authors: L
authors: Shaw
authors: School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, Scotland, UK.
authors: Frederike
authors: F
authors: van Wijck
authors: Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK. c.i.m.price@newcastle.ac.uk.
authors: Christopher
authors: C
authors: Price
mesh_terms: D056044:Actigraphy / Q000295:instrumentation*; D002985:Clinical Protocols; D004739:England; D005081:Exercise Therapy / Q000295:instrumentation* / Q000379:methods; D005240:Feasibility Studies; D030141:Feedback, Psychological; D000072936:Fitness Trackers; D006801:Humans; D009042:Motivation; D010349:Patient Compliance; D010865:Pilot Projects; D020127:Recovery of Function; D017010:Reminder Systems; D012107:Research Design; D020521:Stroke / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D000071939:Stroke Rehabilitation / Q000295:instrumentation* / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D034941:Upper Extremity / Q000294:innervation*
keywords: Accelerometer; Feedback; Randomised controlled trial; Rehabilitation; Self-directed; Self-management; Stroke; Upper limb