MEntal practice for the RehabIliTation of the upper-limb in acute Stroke: a feasibility randomised controlled trial with process evaluation
Stroke
Potential research participants will be screened when they attend the stroke wards at the two NHS locations participating in the study. If they are deemed initially eligible, they will be approached and provided with a participant information sheet in both standard text and also an easy-read version. The hospital research team will go through the information with the patient and answer any questions the patient has. If the patient is informed and willing to participate, they will complete a consent form with the research team and go on to complete physical tests to ensure eligibility for the trial. These tests will be the Oxford Cognitive Screening (OCS), COMPASS, KVIQ-10, and Action Research Arm Test (ARAT). Providing the participant is eligible following these tests, they will go on to complete the baseline questionnaire, which will comprise patient demographics, equity, and clinical data. They will then be randomised to either mental practice or the relaxation application. The hospital research team will provide the participant with a tablet device with the application pre-loaded, a charger, and headphones for use with the tablet device. The hospital research team will go through the application with the participant, ensuring they are comfortable with its use before taking the device with the application home. Participants will be asked to use the application on the device for 20 minutes a day, 5 days a week, over 6 weeks. 6 weeks following recruitment into the trial, participants will have a follow-up appointment with the trial therapist/hospital research team. This will be held either at the hospital or in the participant's home/place of residence. The trial therapist/hospital research team will go through and complete a questionnaire with participants and complete the physical tests, ARAT and Fugl-Meyer Upper Extremity Assessment. Participants will return the tablet device and accessories back to the trial therapist/hospital team. The next follow-up will
1. At least 18 years old 2. Diagnosed with an ischaemic or haemorrhagic stroke within the previous 4 weeks (2 weeks where possible) 3. Demonstrate upper-limb deficits (defined as a National Institute of Health Stroke Scale, NIHSS, Motor Arm score of 1-4 on admission) 4. Baseline Action Research Arm Test of less than 50, indicating significant arm and hand dysfunction 5. Are eligible to receive onward physical rehabilitation either in the community or another rehabilitation setting 6. Can comprehend simple verbal instructions assessed by Oxford Cognitive Screen and 4 items from a subset of the COMPASS Assessment to assess ability to complete multiple-step instructions 7. Can provide feedback on experiences (with support from a carer if required) 8. Are likely to be able to undertake mental practice, evidenced by a score indicating more than 50% correctness on hand laterality judgement test (5/10)
1. Patients who do not have capacity to consent despite materials being available in accessible formats and other languages 2. Have significant hearing loss despite corrective aids 3. Are not fluent (listening) in English, Polish, Indian Punjabi or Urdu 4. Receiving end-of-life care 5. Have significant other impairment of the upper limb such as frozen shoulder, complex regional pain syndrome, orthopaedic injury that would prevent completion of movements required for the outcome measurements 6. Have health conditions that limit or prevent engagement with rehabilitation 7. Currently participating in another stroke rehabilitation trial 8. Are likely to be discharged to a location outside a practical working distance from the recruitment location during the intervention or follow-up period