MEntal practice for the RehabIliTation of the upper limb in acute Stroke: a feasibility randomised controlled trial with process evaluation (MERITS)

Research question: Is a randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of Mental-Practice for the upper-limb, compared to a Relaxation-Control intervention, feasible and acceptable for people between 1 day to 3 months after stroke? Background In the UK, over 100,000 people experience a stroke every year.1 After stroke, up to 70% of people experience problems using their shoulder, elbow, wrist and hand (upper-limb) to undertake even simple daily tasks, reducing independence and well-being.2 UK stroke clinical guidelines (2023) recommend up to six hours of therapeutic activities should be undertaken each day, more than doubling the current best rehabilitation provision in the NHS. This highlights an urgent need to find effective treatments that people after stroke can use independently to augment their rehabilitation. Mental-Practice is a promising treatment in which participants listen to a script that facilitates them to imagine moving their upper-limb to complete a task (e.g. writing). Because Mental-Practice requires no physical movement, it is practical and safe for people with even severe upper-limb limitations to use independently. Systematic reviews indicate that Mental-Practice improves upper-limb function3,4, but few trials evaluated Mental-Practice in the first weeks after stroke, despite this being when there is the greatest potential for recovery. Whilst an RCT of the effectiveness of Mental-Practice is clearly needed, crucial data on feasibility and acceptability are needed to support its design. Aims and objectives Aim: to determine the feasibility and acceptability of a RCT to evaluate the clinical and cost-effectiveness of Mental-Practice for the upper-limb when delivered in addition to usual rehabilitation, and the acceptability of Mental-Practice and Relaxation-Control interventions for people between 1 day to 3 months after stroke. The study will determine: The feasibility of recruitment and retention The feasibility of completing the Mental-Practice intervention in the early subacute period after stroke The acceptability of the study, Mental-Practice and Relaxation-Control interventions Methods Design: stratified, unblinded feasibility RCT with an embedded process evaluation conducted over 24 months Sample: 80 people with upper-limb deficits, within the first two weeks after stroke, able to undertake imagery Procedure: Participants will be stratified based on dominance/non-dominance of arm affected and baseline Action Research Arm Test (ARAT) scores and individually randomised to either receive a Mental-Practice or a time-matched Relaxation-Control intervention. Interventions: Participants will complete either intervention for 20 minutes each day, five days a week for six weeks whilst receiving usual care. Both interventions will be delivered using a co-designed digital application which, after training, will be used independently by participants. Assessment: Recruitment and retention, adherence and fidelity to the interventions and the appropriateness of outcome tools will be collected from participant data and an embedded process evaluation. These data will be used to determine if an application for a full trial is warranted. Anticipated impact and dissemination If indicated, an application for funding for a multi-centred RCT, a refined Mental-Practice intervention and implementation materials will be produced. Journal publications and conference presentations will disseminate findings to an academic audience. Podcasts and patient-friendly reports will inform the stroke community.