Feasibility of a Physiotherapy Programme, with Integrated TelerehabIlitation to Increase Rehabilitation Time and Improve Motor Function
NCT ID: NCT06871878
Last Updated: 2025-03-19
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-31
2027-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Treatment As Usual
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.
No interventions assigned to this group
PRACTISE Physiotherapy
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 Intervention
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.
Interventions
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PRACTISE Physiotherapy Intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* 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
Exclusion Criteria
* 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.
16 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
University of Aberdeen
OTHER
University of Dundee
OTHER
The Stroke Association, United Kingdom
OTHER
Glasgow Caledonian University
OTHER
Responsible Party
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Principal Investigators
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Lorna Paul, PhD
Role: PRINCIPAL_INVESTIGATOR
Glasgow Caledonian University
Central Contacts
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References
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Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
Yang SY, Lin CY, Lee YC, Chang JH. The Canadian occupational performance measure for patients with stroke: a systematic review. J Phys Ther Sci. 2017 Mar;29(3):548-555. doi: 10.1589/jpts.29.548. Epub 2017 Mar 22.
Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990 Apr;57(2):82-7. doi: 10.1177/000841749005700207.
Brown SE, Scobbie L, Worrall L, Mc Menamin R, Brady MC. Access G-AP: development of an accessible goal setting and action planning resource for stroke survivors with aphasia. Disabil Rehabil. 2023 Jun;45(13):2107-2117. doi: 10.1080/09638288.2022.2085331. Epub 2022 Jun 11.
Bachmair EM, Martin K, Aucott L, Dhaun N, Dures E, Emsley R, Gray SR, Kidd E, Kumar V, Lovell K, MacLennan G, McNamee P, Norrie J, Paul L, Packham J, Ralston SH, Siebert S, Wearden A, Macfarlane G, Basu N; LIFT study group. Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial. Lancet Rheumatol. 2022 Jun 27;4(8):e534-e545. doi: 10.1016/S2665-9913(22)00156-4. eCollection 2022 Aug.
Scobbie L, Duncan EAS, Brady MC, Thomson K, Wyke S. Facilitators and "deal breakers": a mixed methods study investigating implementation of the Goal setting and action planning (G-AP) framework in community rehabilitation teams. BMC Health Serv Res. 2020 Aug 25;20(1):791. doi: 10.1186/s12913-020-05651-2.
Scobbie L, McLean D, Dixon D, Duncan E, Wyke S. Implementing a framework for goal setting in community based stroke rehabilitation: a process evaluation. BMC Health Serv Res. 2013 May 24;13:190. doi: 10.1186/1472-6963-13-190.
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Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
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.
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.
Rintala A, Paivarinne V, Hakala S, Paltamaa J, Heinonen A, Karvanen J, Sjogren T. Effectiveness of Technology-Based Distance Physical Rehabilitation Interventions for Improving Physical Functioning in Stroke: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2019 Jul;100(7):1339-1358. doi: 10.1016/j.apmr.2018.11.007. Epub 2018 Dec 6.
Appleby E, Gill ST, Hayes LK, Walker TL, Walsh M, Kumar S. Effectiveness of telerehabilitation in the management of adults with stroke: A systematic review. PLoS One. 2019 Nov 12;14(11):e0225150. doi: 10.1371/journal.pone.0225150. eCollection 2019.
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Laver KE, Adey-Wakeling Z, Crotty M, Lannin NA, George S, Sherrington C. Telerehabilitation services for stroke. Cochrane Database Syst Rev. 2020 Jan 31;1(1):CD010255. doi: 10.1002/14651858.CD010255.pub3.
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Klassen TD, Dukelow SP, Bayley MT, Benavente O, Hill MD, Krassioukov A, Liu-Ambrose T, Pooyania S, Poulin MJ, Schneeberg A, Yao J, Eng JJ. Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation. Stroke. 2020 Sep;51(9):2639-2648. doi: 10.1161/STROKEAHA.120.029245. Epub 2020 Aug 19.
Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
Lee KB, Lim SH, Kim KH, Kim KJ, Kim YR, Chang WN, Yeom JW, Kim YD, Hwang BY. Six-month functional recovery of stroke patients: a multi-time-point study. Int J Rehabil Res. 2015 Jun;38(2):173-80. doi: 10.1097/MRR.0000000000000108.
Related Links
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Stroke rehabilitation in adults NICE guideline Published: 18 October 2023
Other Identifiers
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SA PG2S21\100006
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PRACTISE
Identifier Type: -
Identifier Source: org_study_id
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