Clinical trial NCT06871878: Feasibility of a Physiotherapy Programme, with Integrated TelerehabIlitation to Increase Rehabilitation Time and Improve Motor Function
Official title: PeRsonAlised Community Based TelerehabIlitation Post StrokE to Increase Rehabilitation Time and Improve Motor Recovery: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke Patients
Stroke
Keywords: Stroke
Physiotherapy
Exercise
TelerehabIlitation
Feasibility
Goal-Setting
Self-managment
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: University of Aberdeen
name: University of Dundee
name: The Stroke Association, United Kingdom
First posted: 2025-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 1. Individuals who have experienced a stroke.

   Inclusion criteria:
   * Over 16 years old
   * Within two months of first stroke
   * Requiring community physiotherapy and discharged home from in-patient care
   * Scores 2-4 on the modified Rankin Score on discharge
   * Able to use a computer/tablet or mobile phone with/without help from carers' (participants who lack digital connectivity skills/ Products will be assisted through AbilityNet)
   * Able to understand/communicate in English
   * Capacity to provide informed consent

   Exclusion criteria:
   * Participating in another physical interventional research study
   * Discharged to a nursing home or other long-term care facility
   * Absolute contra-indication to exercise
2. Carers or family members of individuals who have experienced a stroke.

   Inclusion criteria:
   * Significant other/carer of an individual who is part of the PRACTISE study either as a control participant or as an intervention participant
   * Over the age of 16 years
   * Able to join and contribute to an interview, either in-person or via a video conference platform, in English.
3. Treating physiotherapist who will deliver the PRACTISE intervention.

Inclusion criteria:

* UK-based Physiotherapist who has delivered the PRACTISE intervention
* Able to join and contribute to an interview via video conference platform or in person
* Over the age of 18 years

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
measure: Motricity Index
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
measure: Timed Up and Go test
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
measure: The Barthel Index
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
measure: The Stroke Specific Quality of Life questionnaire
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
measure: EQ-5D-5L
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
measure: Fatigue Severity Scale
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
measure: Stroke Self Efficacy Questionnaire
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
measure: The Patient Experience of Treatment and Self-Management after Stroke
timeFrame: Baseline and week 16 only
measure: Number of falls
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
measure: Caregiver strain index
timeFrame: Base line, week 8, week 16 and week 24 (follow up)
Other outcomes:
measure: Adherence/dose-response measure
timeFrame: Each therapy appointment
measure: Feasibility outcomes measures
timeFrame: Recruitment, screening, baseline, week 8, week 16, week 24 (follow up)
measure: Intervention fidelity
timeFrame: Week 1, week 4, week 6, week 16
measure: Process evaluation
timeFrame: immediately after the intervention
measure: Economic outcome measures
timeFrame: From Baseline to week 16
Locations:
Study officials:
affiliation: Glasgow Caledonian University
name: Lorna Paul, PhD
role: PRINCIPAL_INVESTIGATOR
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