Wristband accelerometers to motivate arm exercise after stroke (WAVES): study protocol for a pilot randomized controlled trial

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ISRCTN:82306027. Registered 12 July 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1628-2) contains supplementary material, which is available to authorized users

Motivating Mobility - An exploration of developing upper limb rehabilitation technology tailored to individual stroke patients needs

Introduction Half of all patients commencing stroke rehabilitation have marked impairment of the hemiplegic arm, with only 5% of those with severe paralysis regaining useful function. Current opinion in motor learning, reinforced by clinical evidence supports the use of repetitive movement practice, feedback and goal orientation to improve rehabilitation. This study aims to motivate people to practise their rehabilitation by extending their activities using a combination of technology and interactive personal games. The multi-disciplinary team comprises physiotherapists, design engineers and computer scientists. Method Two chronic hemiplegic stroke participants were selected via an interview and screening criteria. Ethical approval and written informed consent were obtained. Participative user centred design techniques were used over three months to assess patients’ rehabilitation aims, movement abilities and interests. Notes, photos and video were recorded. Results Two prototype technologies were designed: i) A device enabling a severely impaired patient to play with her toddler using her hemiplegic arm to guide balls down a shute. ii) A chess game in which the participant uses his hemiplegic hand to select a piece using a pressure sensitive sensor, whilst the unaffected hand keys in the move. Conclusion A user centred approach enabled technologies to be designed with stroke patients which addressed their rehabilitation aims as well as their real life interests. These technologies will now be deployed in the home for one month with physiotherapy outcome measures being taken before and after the deployment along with a semi structured interview to assess users’ perceptions of comfort, usability and acceptability