WAVES
Research type
Research Study
Full title
Wristband Accelerometers to motiVate arm Exercise after Stroke, a pilot randomised controlled trial(WAVES). \n
IRAS ID
197650
Contact name
Christopher Price
Contact email
Sponsor organisation
Northumbria Healthcare NHS Foundation Trust
ISRCTN Number
ISRCTN82306027
Duration of Study in the UK
1 years, 8 months, 28 days
Research summary
Study aim: To assess the feasibility of a multi-centre, observer blind, randomised controlled trial of wrist worn accelerometers with vibrating-alert and visual feedback to prompt functional exercise of the upper limb during rehabilitation after stroke.\nStudy design: Observer blind, parallel group, pragmatic pilot randomised controlled trial. \nStudy setting: NHS stroke services in the North East of England who provide in-patient and community therapy follow up services.\nStudy participants: 60 patients who have had a stroke more than 48 hours, but less than 3 months previously, resulting in new reduced upper limb function and are still within an NHS stroke rehabilitation service. \nStudy intervention treatment: An NHS therapist will review participants twice weekly and agree a programme of upper limb activities for the participant to practice in addition to usual care. Intervention participants will be provided with a wrist worn movement detector (accelerometer) with an integrated vibrating-alert function and visual display feedback (the CueS device) to: a) constantly sense impaired limb movement; b) gently vibrate to prompt more limb use if activity falls below a personalised threshold; c) provide visual feedback on achievement towards the threshold and d) provide patients and therapists with a twice weekly objective report of movement and prompts. Participants will wear the CueS device for four weeks. \nStudy control treatment: An NHS therapist will review participants twice weekly and agree a programme of upper limb activities for the participant to practice whenever they choose in addition to usual care. Control participants will wear a ‘sham’ CueS device for four weeks which will monitor impaired limb activity but will not provide prompts, feedback or reports to guide therapy. \nStudy outcomes: Feasibility of the study protocol (recruitment, retention, adverse events) and data to inform the design of a future multi-centre randomised controlled trial (adherence).\nStudy duration: 24 months.\n
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0063
Date of REC Opinion
29 Mar 2016
REC opinion
Further Information Favourable Opinion