About two thirds of people after stroke have some level of disability. Rehabilitation helps to reduce disability and supports people to return to a meaningful life. We know that the more rehabilitation you do especially, within the first six months after stroke, the better the outcome. However, rehabilitation services, especially in the community, are often lacking, non-specialist or provide only a limited number of therapy sessions. Recently national guidelines for care of people after stroke recommend that people receive up to three hours/day of therapy on at least five days/week. NHS services cannot provide this level of therapy so new ways to support people to increase the amount of therapy they do on their own is needed.
The aim of the research is to test a 16 week community, home-based physiotherapy programme to improve the amount of therapy exercise a stroke survivor does, therefore improving the outcome and reducing the level of disability.
Participants will be recruited as they transition from inpatient services to community physiotherapy. Participants will be randomised to either the control or intervention arm. Participants in the intervention arm will take part in a 16-week community, home-based physiotherapy programme. Within the 16-week intervention, participants will receive 5 home based and 4 remote appointments which will comprise of usual physiotherapy assessment and exercise prescription that incorporates 1) Personalised online exercise programme delivered through the Giraffe platform; 2) Goal setting and Action Planning (G-AP); and 3) Supported self-management approaches. Participants will receive an intervention workbook to support them with strategies to achieve their goals and build their self-management skills e.g. how to integrate therapy into their daily life, dealing with barriers, identifying social support networks.
Participants randomised to the control group will receive usual multi-disciplinary rehabilitation from their care team (e.g., physiotherapist, Occupational Therapists, Speech and Language Therapists) as per their NHS Health boards care plan.
The study will measure both feasibility outcomes associated with the implementing the study alongside clinical and wellbeing measures.
To test the feasibility of the study we will assess how many people agree to take part, complete the exercise sessions and complete the outcome measurements. We will also interview people affected by stroke, their significant others if appropriate, and therapists to get their views on the programme. We will do clinical assessments too at four time points across the study looking at walking ability, arm function, level of disability, confidence level, fatigue and quality of life.
Individuals who have experienced a stroke.
Over 16 years old
Within two months of first stroke
Requiring community physiotherapy and discharged home from in-patient care
Participating in another physical interventional research study
Discharged to a nursing home or other long-term care facility
Absolute contra-indication to exercise
Carers or family members of individuals who have experienced a stroke.
Parallel
PRACTISE Physiotherapy Intervention
Other interventionThe PRACTISE programme is a 16-week personalised physiotherapy programme, incorporating tele-rehabilitation, which aims to support individuals to achieve optimal dose of exercise to improve motor and functional outcomes after stroke. There are three core components to the intervention: goal setting, exercise and a supported self-management approach. PRACTISE comprises of nine therapist supported sessions: five in person, home-based rehabilitation sessions (weeks 1-4, two visits in week 1) and four telephone or video consultations (Near Me) (weeks 6, 8, 12 and 16), a simple self-management workbook (with space to record personal goals, action plans and progress) to develop skills for self-management, and a personalised online exercise programme delivered through the Giraffe platform five times per week.
Canadian Occupational Performance Measure (COPM)
The main aim of the Canadian Occupational Performance Measure is to identify occupational performance problems, concerns and issues of participants (wants to do, needs to do or is expected to do, but can't do, doesn't do or isn't satisfied with the way they do it). Through a discussion, participant identifies up to five problems they face in self-care, productivity and leisure. They then prioritise the activities and rate their current level of performance and satisfaction with each. The COPM is generally a reliable, valid, and acceptable tool for researchers with satisfactory test-retest reliability specifically in stroke. COPM results will be given to physiotherapist of intervention participant. This will allow discussion between the participant and physiotherapist to agree specific, and meaningful goals using the G-AP framework.
Action Research Arm Test (ARAT)
The Action Research Arm Test is a 19-item physical measure to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery. It comprises 4 sub-tests (grasp, grip, pinch, and gross arm movement). Within each sub-test, assessments are arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Item scored on a four-point scale from 0 (can do no part of the test) to 3 (performs the test normally).
Motricity Index
Motricity Index assesses motor impairment and muscle strength of the upper and lower limbs and involves three upper limb activities; shoulder abduction, elbow flexion and pinch grip and three lower limbs; hip extension, knee extension and ankle dorsiflexion.
Timed Up and Go test
Timed up and go test assesses mobility, balance, walking ability, and fall risk. The participant stands from a chair, walks 3 metres at a comfortable pace, turns around, walks back to the chair and sits down. The time to complete the test is recorded and walking aids are used as required. The test will be conducted three times with the average score being calculated and used as the final measure.
The Barthel Index
The Barthel Index is a patient reported outcome and measures the extent to which somebody can function independently and has mobility in their activities of daily living. Activities of daily living measured include feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Each activity is scored out of 10, with a maximum of score 100.
Adherence/dose-response measure
Care delivered by physiotherapists, occupational therapists and speech and language therapists, for both CONTROL and INTERVENTION groups will be recorded by the therapist using a short checklist. This will include, date of appointment, duration of appointment, who the appointment was with (e.g., physiotherapist, speech and Language), and content via a checklist of usual care interventions. This will be completed for each therapy appointment Exercise diaries will be completed by participants either in the Giraffe platform (intervention) or paper (control). This information will be used to determine the weekly dose of exercise from which dose/response will be calculated for the clinical outcomes.
Feasibility outcomes measures
Data from screening, recruitment and follow-up logs will be used to generate realistic estimates of eligibility, recruitment, consent and follow-up rates, reasons for drop-out and adverse events. Outcome measure completion and missing data will also be recorded.
Intervention fidelity
To understand fidelity of PRACTISE, 20 audio recordings of PRACTISE sessions between a physiotherapist and a participant will be made. This will include 5 on session-1 (week 1), 5 on session-5 (week 4), 5 on session-6 (week 6) and 5 on session-9 (week 16). Physiotherapists will record these sessions via a Dictaphone. Equal representation will be sought across site locations.
Process evaluation
Interviews will be conducted to assess fidelity, acceptability and adherence of the study. Interviews will be conducted with: 1. individuals who have had experienced a stroke, 2. carer or significant others and 3. treating physiotherapist. Interviews will be conducted after the 16-week intervention period for individuals who have experienced a stroke and for carers or significant others. Therapist interviews will be conducted when their involvement in the study is complete.
Click on the lead sponsor to view all of their trials.
Glasgow Caledonian University
Lead sponsor
University of Glasgow
Collaborator
University of Aberdeen
Collaborator
University of Dundee
Collaborator
The Stroke Association, United Kingdom
Collaborator
