Co-designing a Stroke Rehabilitation Trial Toolkit

NCT07484958 | Enrolling By Invitation

• 1 other identifier: Ethics Application 6320
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical trials are a type of research that tests if a treatment works well and is safe, so future care can be improved. In stroke rehabilitation, clinical trials are essential for improving the lives of stroke survivors. Clinical trials follow detailed plans called protocols, that explain what activities should be done, by whom and when. This makes sure everyone in the trial does things the same way, so results are fair and consistent. Sometimes, stroke survivors or staff may not follow the trial protocol exactly. For example, someone might miss a session or do different exercises. This is called low adherence. There are many reasons this can happen; the exercises or schedule may be too hard, the trial or activities do not match what stroke survivors or staff need, prefer, or find helpful in real life. If protocols are not followed properly, the trial results of clinical trials may not be reliable. This can slow down the process of getting better treatments into hospitals and make it harder to improve rehabilitation for future stroke survivors. Previous research has looked at what helps and gets in the way of adhering to protocols during hospital-based stroke rehabilitation trials. The research has identified many factors, including the healthcare system, hospital environment, staff, patients and the rehabilitation activities or schedules. Most of this research focused on the views of staff involved, meaning important perspectives may be missing from others involved in stroke rehabilitation trials. The investigators' study aims to change that. The investigators want to hear from people whose voices are often overlooked: stroke survivors, their family and friends, stroke rehabilitation staff and healthcare leaders working in the NHS, stroke rehabilitation researchers, staff working in Integrated Care Boards (who help plan and coordinate NHS services in local areas) and representatives from organisations who fund stroke rehabilitation research. The investigators will use a process called co-design. This means working together to develop a toolkit to help improve adherence in future stroke rehabilitation trials. Toolkits are already used in healthcare to help people do things better. For example, changing how care is given, supporting patients, or helping health teams work more smoothly. But currently, there is no toolkit designed specifically to help improve adherence to stroke rehabilitation trial protocols. This research aims to design a toolkit together. The toolkit will be shaped by a wide range of voices, especially those from underrepresented groups, and made in a way that's easy to understand and use. By addressing potential barriers early on, the investigators hope the toolkit will make it easier for future stroke rehabilitation trials to succeed, leading to better recovery and quality of live for stroke survivors.

Conditions

Stroke; Rehabilitation; Co-design

Keywords

Stroke rehabilitation; Co-design; Adherence; Clinical trials

Outcome Measures

Primary Outcomes (1)

• Survey, individual interviews, and group discussions This is co-design research the output will be the co-designed toolkit.

  STAGE 1 SURVEYS: Total number of surveys completed which will be categorised by participant groups, e.g., stroke survivors, family/friend of stroke survivor, stroke rehabilitation staff, healthcare leader, stroke rehabilitation researcher, funder. Data will be analysed as follows: * Descriptive statics (frequencies, percentages, and median responses) * Statistical tests (t-tests, ANOVA, correlation) STAGE 2 INTERVIEWS: Data will be analysed using thematic analysis which will inform stages 3 and 4. STAGE 3 JOINT DISCUSSIONS: Approximately 16 participants; a mix of all groups will attend a 2-hour joint event. STAGE 4 CO-DESIGN WORKSHOPS: Three co-design workshops will take place over the course of 8 weeks. Up to 20 participants (a mix of groups).

  Time Frame: From March 2026 to February 2027

Study Arms (6)

Stroke survivors

Stroke survivors aged 18 years and over

Other: Co-designing a stroke rehabilitation toolkit

Stroke rehabilitation staff

Staff with more than 6 months experience of working in inpatient stroke rehabilitation, e.g., nurse, occupational therapist, physiotherapist, rehabilitation physician

Other: Co-designing a stroke rehabilitation toolkit

Healthcare leaders

Individuals who are accountable and responsible for the operational, clinical, and/or strategic delivery of stroke rehabilitation, rehabilitation and/or therapy services within a NHS hospital * Individuals working in an Integrated Care Board with rehabilitation and/or research in their portfolio * Experience in implementing/influencing stroke rehabilitation policy/service delivery

Other: Co-designing a stroke rehabilitation toolkit

Stroke rehabilitation researchers

Active researchers with experience in designing, conducting and evaluating stroke rehabilitation or physical rehabilitation research * Affiliated with academic or research institutions * Willing to participate in co-design activities and share their perspectives.

Other: Co-designing a stroke rehabilitation toolkit

Stroke rehabilitation funders

* Currently employed, contracted to, or formally affiliated with a research funding organisation that reviews, commissions or funds stroke rehabilitation research (e.g., NIHR, Stroke Association, research councils, medical research councils, professional bodies or research charities) * Direct involvement in decision-making, monitoring or governance of stroke rehabilitation research within the past two years * Experience with funding processes related to stroke rehabilitation, rehabilitation or clinical trial oversight

Other: Co-designing a stroke rehabilitation toolkit

Family member or friend of stroke survivor

* Adults (aged 18+) who are a family member, friend, or informal caregiver of a stroke survivor. * Able and willing to provide informed consent. * Willing to participate in co-design activities and share their perspectives.

Other: Co-designing a stroke rehabilitation toolkit

Interventions

Co-designing a stroke rehabilitation toolkit OTHER

STAGE 1 NATIONAL ONLINE SURVEY: to capture a broad range of views from those involved in stroke rehabilitation trials, e.g. all groups. This will help identify key themes for deeper exploration in STAGE 2. STAGE 2 INTERVIEWS: with up to 14 participants, a mix of research partners. Interviews will be online via Zoom or Microsoft Teams. Interviews will be audio recorded. A short film, called a catalyst film, will be created from the survey and interviews. STAGE 3 JOINT DISCUSSIONS: Approximately 16 participants; a mix of all groups will attend a 2-hour joint event. The catalyst film created from STAGES 1 and 2 will be shown. STAGE 4 CO-DESIGN WORKSHOPS: Three co-design workshops will take place over the course of 8 weeks. Up to 20 participants (a mix of groups). STAGE 5: CELEBRATION EVENT: showcase the co-designed outcomes, celebrate participant contributions, and share learning with wider stakeholders.

Family member or friend of stroke survivor; Healthcare leaders; Stroke rehabilitation funders; Stroke rehabilitation researchers; Stroke rehabilitation staff; Stroke survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke survivors, family member or friend of stroke survivor, stroke rehabilitation staff, healthcare leaders, stroke rehabilitation researchers, funders of stroke rehabilitation research.

You may qualify if:

• Adults (aged 18+) who have experienced a stroke. No time limit since stroke
• Able to provide informed consent
• Sufficient communication abilities (verbal or non-verbal, with or without support) to participate in co-design activities
• Received inpatient stroke rehabilitation after their stroke
• Has or has not previously participated in a stroke rehabilitation clinical trial during their hospital-based stroke rehabilitation
• Willing to participate in co-design activities and share their perspectives.
• Adults (aged 18+) who are a family member, friend, or informal caregiver of a stroke survivor.
• Able and willing to provide informed consent.
• Willing to participate in co-design activities and share their perspectives.
• Registered staff currently working in stroke rehabilitation who routinely prescribe and/or supporting stroke rehabilitation activities (e.g., physiotherapist, occupational therapist, rehabilitation nurses, rehabilitation physician)
• ≥6 months of experience in hospital-based stroke rehabilitation settings
• Employed in an organisation that provides NHS hospital-based stroke rehabilitation services
• Willing to participate in co-design activities and share their perspectives.
• Individuals who are accountable and responsible for the operational, clinical, and/or strategic delivery of stroke rehabilitation, rehabilitation and/or therapy services within a NHS hospital
• Individuals working in an Integrated Care Board with rehabilitation and/or research in their portfolio

You may not qualify if:

• Participants will not be eligible if they meet any the following criteria:
• Significant cognitive and/or communication impairment that preclude meaningful participation, even with support
• Exhibiting aggression or other behaviour issues that put themselves and others at risk
• Medical instability that would make participation unsafe or overly burdensome
• Currently enrolled in another research study that could confound participation or data collection
• Non-English speaking (research study does not offer language support).
• Not family member or friend of a stroke survivor
• Significant emotional distress or trauma that would be exacerbated by participation.
• Non-English speaking (research study does not offer language support).
• Currently under disciplinary review or leave of absence.
• ≤6 experience in NHS inpatient stroke rehabilitation
• Inability to commit time to the study activities.
• Not in a leadership or decision-making role within an organisation that provides NHS inpatient stroke rehabilitation or rehabilitation/therapy services
• Not working in an Integrated Care Board/System
• No experience in implementing or influencing stroke rehabilitation policy or service delivery

Sponsors & Collaborators

• University of Plymouth: lead
• Royal Devon and Exeter NHS Foundation Trust: collaborator

Study Sites (1)

University of Plymouth, Faculty of Health

Plymouth, Devon, PL4 6AB, United Kingdom

Location

Related Publications (5)

• Barac R, Stein S, Bruce B, Barwick M. Scoping review of toolkits as a knowledge translation strategy in health. BMC Med Inform Decis Mak. 2014 Dec 24;14:121. doi: 10.1186/s12911-014-0121-7.

  PMID: 25539950 RESULT

• Hempel S, O'Hanlon C, Lim YW, Danz M, Larkin J, Rubenstein L. Spread tools: a systematic review of components, uptake, and effectiveness of quality improvement toolkits. Implement Sci. 2019 Aug 19;14(1):83. doi: 10.1186/s13012-019-0929-8.

  PMID: 31426825 RESULT

• Logan A, Marsden J, Freeman J, Cork E, Kent B. Optimising adherence to inpatient rehabilitation trial protocols: A mixed-methods systematic review. Clin Trials. 2025 Dec;22(6):728-744. doi: 10.1177/17407745251358262. Epub 2025 Nov 6.

  PMID: 41195536 RESULT

• Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x.

  PMID: 22486599 RESULT

• Stinear CM, Lang CE, Zeiler S, Byblow WD. Advances and challenges in stroke rehabilitation. Lancet Neurol. 2020 Apr;19(4):348-360. doi: 10.1016/S1474-4422(19)30415-6. Epub 2020 Jan 28.

  PMID: 32004440 RESULT

Related Links

• Study website

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan Marsden, PhD

  University of Plymouth

  PRINCIPAL INVESTIGATOR

• Angie Logan, PhD

  University of Plymouth

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rehabilitation

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 20, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

GB (1)