Feasibility of a Physiotherapy Programme, with Integrated TelerehabIlitation to Increase Rehabilitation Time and Improve Motor Function

Not Applicable

Not yet recruiting

• Conditions: Stroke Patients; Stroke

• Registration Number: NCT06871878
• Lead Sponsor: Glasgow Caledonian University

Brief Summary

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.

Detailed Description

Stroke affects around 100,000 people in the UK each year, is the leading cause of disability and the fourth leading cause of death in the UK. The first six months after stroke is the optimum time for neuroplasticity and recovery and therefore a critical period for rehabilitation. Exercise post-stroke needs to be repetitive, task-specific and high-dose to optimise motor and functional recovery. The recent National Clinical Guideline for Stroke recommends patients should receive at least three hours a day of multidisciplinary therapy at least five days week. Delivering this dose of therapy in community settings is challenging (e.g., waiting lists, therapist availability) and around 40% of stroke survivors are discharged home without any further rehabilitation and thus receive sub-optimal levels of therapeutic rehabilitation. Subsequently, alternative models of rehabilitation are required and there is a

One approach is to empower stroke survivors to take control of their own personal rehabilitation needs outside of NHS appointments. Progressing individuals towards the volume of therapy recommended by National Clinical Guideline for Stroke for optimal recovery benefits. Therefore, the investigators are seeking to combine previous stroke based research, from distinct areas, notably, Tele-rehabilitation, goal setting and self-management.

The PRACTISE intervention is based upon the use of tele-rehabilitation (Giraffe platform) incorporating evidence-based behavioural change techniques, with the addition of an evidence-based approach to support patients to set and pursue their personal goals (the Goal setting and Action Planning framework) and support for therapists to build trusted and supportive relationships for self-management (IMPETUS study).

Tele-rehabilitation, recommended by the new Stroke Guidelines, has the potential to address the issues of sub-optimal levels of therapeutic care by offering access to specialist services, reducing transport requirements/costs (therapist and patient), whilst allowing for personalisation services, increased dose of therapy and enhanced monitoring. The Telerehabilitation platform, Giraffe allows therapists to provide personalised, video-based exercise programmes and with an inbuilt exercise diary. Previous research has shown the feasibility of the Giraffe platform to augment upper-limb physiotherapy at the in-patient stage of stroke rehabilitation (30mins of additional therapy, up to five times/week) and found the intervention to be feasible, safe and acceptable to patients, carers and Physiotherapists.

Goal setting is a central and recommended component of stroke rehabilitation practice. The Goal setting and Action Planning (G-AP) framework is a theory- and evidence-based method, developed by one of our team, to support stroke survivors to consider, plan, and work towards their goals collaboratively with rehabilitation staff. Evaluations of G-AP in community stroke rehabilitation settings found it was acceptable to staff and people in their care, feasible to implement in practice and helpful in the setting and pursuit of person-centred goals.

Supported self-management is advocated for within national clinical guidelines and current stroke policies. It's an approach designed to help stroke survivors to regain their confidence to manage the impact of their stroke and live their lives well after a stroke. The IMPETUS study showed that supported self-management helps to improve stroke survivor's quality of life, confidence, independence and helps people to adopt lifestyle changes that reduce their risk of secondary stroke. Within PRACTISE, supported self-management is a collaborative discussion and mutual understanding between physiotherapist and participant to help people to develop the skills and confidence to self-manage well. Conversations with therapists will be supplemented with educational awareness components via a participant workbook that will support the participant 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.

The ultimate aim of this research is to determine if a personalised, goal-based, physiotherapy programme, with integrated tele-rehabilitation, to improve motor and functional outcomes in the first six months after stroke (PRACTISE), is clinically and cost effective compared to usual care. Prior to undertaking a definitive randomised controlled trial (RCT) this feasibility study will explore uncertainties about the intervention and trial.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-12
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Study Start: 2025-05
• Primary Completion: 2026-12
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	Base line, week 8, week 16 and week 24 (follow up)	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.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	Base line, week 8, week 16 and week 24 (follow up)	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	Base line, week 8, week 16 and week 24 (follow up)	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	Base line, week 8, week 16 and week 24 (follow up)	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	Base line, week 8, week 16 and week 24 (follow up)	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.
The Stroke Specific Quality of Life questionnaire	Base line, week 8, week 16 and week 24 (follow up)	The Stroke Specific Quality of Life questionnaire consists of 49 items each assessed on a 5-point scale. The domains covered include mobility, energy, work and productivity, mood, self-care, language, thinking and personality. Scores range from 49 to 245 with higher scores associated with higher quality of life.
EQ-5D-5L	Base line, week 8, week 16 and week 24 (follow up)	EQ-5D-5L evaluates health-related quality of life with one question for each of the five dimensions mobility, self- care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The Eq-5D-5L also comprises a visual analogues scale that records the participants self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Fatigue Severity Scale	Base line, week 8, week 16 and week 24 (follow up)	Fatigue Severity Scale is 9-item scale, that is self reported by participants. The scale measures the severity of fatigue and its effect on a person's life against 9 statements. Each item is scored on a scale of 1 (strongly disagree) -7 (strongly agree). Scores range from 9 to 63 with higher scores indicating more severe fatigue.
Stroke Self Efficacy Questionnaire	Base line, week 8, week 16 and week 24 (follow up)	Stroke Self Efficacy Questionnaire is a self-report scale of self-efficacy post stroke that demonstrates good internal consistency and criterion validity. It is a 13-item patient reported outcome where participants rate their confidence with stated tasks from 0 not at all confident to 10 very confident. The SSEQ total score can potentially range from 0 to 130 with higher scores indicating higher levels of self-efficacy.
The Patient Experience of Treatment and Self-Management after Stroke	Baseline and week 16 only	The Patient Experience of Treatment and Self-Management was developed to measure treatment burden in people with multi-morbidity and/or complex self-management regimens. However, it omits stroke-specific burdens. Therefore, the Patient Experience of Treatment and Self-Management after Stroke (PETS-STROKE) PETS-STROKE is a 34-item patient reported measure that captures the workload of healthcare and impact on wellbeing experienced by the stroke survivor.
Number of falls	Base line, week 8, week 16 and week 24 (follow up)	The number of falls since the previous assessment will be self-reported, with a fall defined as 'an unexpected event in which the participant comes to rest on the ground, floor or lower'. As the intended outcome of the intervention is to increase functional activity this may increase risk of falls.
Caregiver strain index	Base line, week 8, week 16 and week 24 (follow up)	Caregiver strain index This is a self report written questionnaire across 13-items which assesses the level of stress experienced by informal caregivers, answered with - Yes (2), Sometimes (1) or No (0). The maximum score is 26.