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

NCT06871878 | Not Yet Recruiting DMC

• 2 other identifiers: PRACTISESA PG2S21\100006
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke Patients; Stroke

Keywords

Stroke; Physiotherapy; Exercise; TelerehabIlitation; Feasibility; Goal-Setting; Self-managment

Outcome Measures

Primary Outcomes (1)

• 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.

  Base line, week 8, week 16 and week 24 (follow up)

Secondary Outcomes (11)

• Action Research Arm Test (ARAT)

  Base line, week 8, week 16 and week 24 (follow up)

• Motricity Index

  Base line, week 8, week 16 and week 24 (follow up)

• Timed Up and Go test

  Base line, week 8, week 16 and week 24 (follow up)

• The Barthel Index

  Base line, week 8, week 16 and week 24 (follow up)

• The Stroke Specific Quality of Life questionnaire

  Base line, week 8, week 16 and week 24 (follow up)

Other Outcomes (5)

• Adherence/dose-response measure

  Each therapy appointment

• Feasibility outcomes measures

  Recruitment, screening, baseline, week 8, week 16, week 24 (follow up)

• Intervention fidelity

  Week 1, week 4, week 6, week 16

Study Arms (2)

Treatment As Usual

NO INTERVENTION

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.

PRACTISE Physiotherapy

EXPERIMENTAL

The 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.

Other: PRACTISE Physiotherapy Intervention

Interventions

PRACTISE Physiotherapy Intervention OTHER

The 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.

PRACTISE Physiotherapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• Treating physiotherapist who will deliver the PRACTISE intervention.
• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• University of Glasgow: collaborator
• University of Aberdeen: collaborator
• University of Dundee: collaborator
• The Stroke Association, United Kingdom: collaborator

Related Publications (19)

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  PMID: 32843039 BACKGROUND

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  PMID: 23705824 BACKGROUND

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  PMID: 21131335 BACKGROUND

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  PMID: 23512568 BACKGROUND

• Alhusayni AI, Cowey ES, Coulter E, Barber M, Paul L. Personalised Online Upper-Limb Physiotherapy for Stroke Survivors during the Inpatient Phase: A Feasibility Study. Healthcare (Basel). 2023 Sep 19;11(18):2582. doi: 10.3390/healthcare11182582.

  PMID: 37761779 BACKGROUND

• Paul L, Renfrew L, Freeman J, Murray H, Weller B, Mattison P, McConnachie A, Heggie R, Wu O, Coulter EH. Web-based physiotherapy for people affected by multiple sclerosis: a single blind, randomized controlled feasibility study. Clin Rehabil. 2019 Mar;33(3):473-484. doi: 10.1177/0269215518817080. Epub 2018 Dec 4.

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Related Links

• Stroke rehabilitation in adults NICE guideline Published: 18 October 2023

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Lorna Paul, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin B Shore, PhD

CONTACT

+44 141 331 3807; colin.shore@gcu.ac.uk

Lorna Paul, PhD

CONTACT

PRACTISE@gcu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An assessor who will collect outcome measures will be blinded to the groups. This study has an intervention and a usual care arm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 12, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be stored on One Drive for 10 years, after which it will be deleted and CRFs will be shredded as confidential waste.
• Access Criteria: All IPD that underlie results in a publication will be available at request and stored on a Glasgow Caledonian University OneDrive account.