StrokeCROFTERSNCT06928285
Community Rollout of Technology Enriched Rehabilitation After Stroke: An Implementation Study
A study testing Technology Enriched Rehabilitation in people with Stroke, run by University of Strathclyde.
Trial summary
The minimum guideline recommendations for rehabilitation after stroke are not being met. This compromises individual recovery and increasing the global burden of disability. A multi-technology solution, co-created with people living with stroke, has been shown to be feasible in both sub-acute and chronic populations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Technology Enriched Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke
- Currently well
- Suitable for rehabilitation (motor/ciommunication and or/cognitive impairment(
- Able to attend the programme for two hours at least twice a week
- Able to follow instructions in English and follow provide verbal and/or written feedback
Who cannot join
- Absolute contradictions to physical activity
- Recent (6 weeks) deterioration in health
- Change in medication
- Currently unwell
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Milena Sklachetka Research Physiotherapist, M.Sc. contact
About this study
The minimum guideline recommendations for rehabilitation after stroke are not being met. This compromises individual recovery and increasing the global burden of disability. A multi-technology solution, co-created with people living with stroke, has been shown to be feasible in both sub-acute and chronic populations but has not been implemented as an integrated rehabilitation service.
The aim of this implementation study is to assess the ability of a technology enriched model of rehabilitation to deliver guideline recommendations in a range of NHS and local authority settings that provide rehabilitation services to stroke survivors at different stages of their recovery. The findings will be used to co-create a scalable, adaptable, and sustainable model that meets rehabilitation guidelines.
Read the detailed description
A recently completed pilot study (NCT05981729) demonstrated the feasibility of our multi-technology circuit based model of rehabilitation in an acute NHS stroke unit (UHW, NHS Lanarkshire). The key findings were that the model delivered an average of 52 minutes of additional rehabilitation every day, without any safety concerns and with supervision provided by rehabilitation assistants. Importantly for future implementation the participating patients and ward staff were all very positive about the novel approach. The challenge now is to translate these positive findings into a sustainable national solution that maintains fidelity to the key parameters of evidence-based rehabilitation (personalised, high intensity, and enriched environment) and can be adopted by diverse service providers (NHS, Local Authority, and medical charities) across various settings, to support people through their whole recovery journey.
Aim To develop an acceptable and sustainable implementation model of technology enriched rehabilitation after stroke that sustainably delivers NICE (National Institute for Clinical Effectiveness) guideline recommendations in a range of rehabilitation settings and phases of recovery after stroke.
Design This is an implementation study using a mixed methods approach to assess technology enriched rehabilitation gyms across a network of NHS, local authority and 3rd sector funded rehabilitation services. Part of the implementation study will involve gathering preliminary evidence of efficacy through comparison with a control group matched for age and stroke through a data linkage project (eDRIS, Data Scotland).
Locations Four locations have agreed to participate, they represent different stages of recovery after stroke, from acute illness (University Hospital Wishaw, Wishaw, UK) to community care (Blantyre Life, Blantyre, UK) and Edinburgh Community Stroke Service, Edinburgh, UK) and long-term maintenance (Olympia leisure centre, Dundee, UK). At one location (Edinburgh) the study will also test whether a higher dose of rehabilitation can be delivered within current resources including participant tolerance and what resources are required to maintain a high dose delivery.
Participants All participants will have a diagnosis of stroke (physician diagnosed) and be suitable for rehabilitation. Specific eligibility criteria, such as time since stroke, will vary across the locations and are detailed later.
Intervention This will be delivered by the local teams of suitably qualified (e.g. physiotherapists) staff following training from the Strathclyde team.
Intervention parameters Frequency: at least twice a week Intensity: Always sub-maximal. Determined by the amount of time spent in each activity and (where possible) the number of movements (e.g. steps on treadmill) performed Time: 2 hours max with activities varied between seated and standing Total duration: 8 weeks
Content
The TERG intervention has been described in general terms in recent publications (Kerr, Grealy et al. 2021, Kerr, Keogh et al. 2023) and is detailed in a comprehensive manual which will be used for training and to improve fidelity. The key elements are described below:
Once consent has been taken and outcome measures have been recorded each participant should be supported in setting three personal goals. Some training will be provided around effective goal setting. These, together with the initial outcome measures, will be used to structure an initial training programme that will be reviewed regularly (every 2 weeks). The programme will only use the technology listed below and individuals should be trained (as much as possible) to use the equipment on their own, with physical assistance and support provided by the supervising staff.
Rehabilitation equipment and purpose:
- Treadmill with adjustable walking harness system. Purpose: Gait and balance training
- Large, height adjustable, computer tablet with digital health apps. Purpose: Communication and cognitive training performed in standing or sitting
- GripAble hand trainer. Purpose: Upper limb training and cognitive training
- Mirror Therapy. Purpose: Motor priming \& upper limb training
- Power assisted Seated rower. Purpose: General exercise, aerobic, strength, flexibility
- Power assisted Cross cycle trainer. Purpose: General exercise, aerobic, strength, flexibility
- Power assisted Seated climber. Purpose: General exercise, aerobic, strength, flexibility
- Power assisted bike: Purpose: General exercise, aerobic, strength, flexibility
- VR headset; Purpose: Upper limb and balance upper limb co-ordination and balance
On completion of the 8 week programme outcome measures will be repeated and participants will be interviewed by a researcher not involved in the programme delivery to understand the user experience.
Data collected
- Participant attendance (number sessions attended) and engagement (movements performed) with activities.
- Incidence of safety events (adverse events)
- Interviews with staff and participants
- Delivery costs (staff and equipment)
- Standard measures of mobility (10 mwt, five times sit to stand), communication and patient reported outcomes on function (Rivermead Mobility Index) and quality of life (Stroke Impact Scale). These will be recorded before the programme begins and immediately after completion.
- Health and Care costs for 6 months after intervention through a data linkage project
- Conditions
- Stroke
- Being tested
- Technology Enriched Rehabilitation
- Keywords
- rehabilitation, technology, implementation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology Enriched RehabilitationOther
The intervention is an 8-week long rehabilitation programme delivered entirely through technology, including virtual reality (immersed and non-immersed), treadmills, weight suspension and movement resistance, and power assistance equipment located in a gym-like space on a university campus. Individual programs are designed, supervised, and reviewed by a physiotherapist using principles of intensity, feedback, cognitive engagement, and aerobic activity to address the goals identified by the participant and scores from outcome measures at baseline. Participants should attend a minimum of two times per week and can more frequently for the two hour group based circuit class.
| Study group | Role | What they receive |
|---|---|---|
| Technology enriched rehabilitation: Intervention | Experimental | People well enough to exercise lightly but living with motor impairment following a stroke will attend a personalised circuit based programme in a technology enriched rehabilitation gym with exercise and activities structured around their motor, communication and cognitive impairments. Receives: Other: Technology Enriched Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-meter walk test (10mWT)
Time to walk 10 metres
Measured: Three time points; 1) Two weeks before intervention starts at the initial induction meeting,2) immediately before the intervention, and 4) immediately after intervention ends
Five times sit to stand movement
Time to complete five sit to stand movements safely.
Measured: Three time points; 1) Two weeks before intervention starts, at the induction meeting,2) immediately before the intervention and 3) immediately after intervention ends
Secondary outcomes (2)
Stroke Impact Scale
Quality of life index for people after stroke
Measured: Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends
Action Research Arm Test (ARAT)
19 item observational measure to assess upper extremity performance (coordination, dexterity and functioning) after stroke
Measured: Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Implementation study assessing; 1. ability to sustainably deliver NICE (National Institute for Clinical Effectiveness, UK) recommendations for rehabilitation after stroke (intensity and dose) 2. Response from participants including changes to mobility, communication and impact on life. This will include a data linkage control group with dat aopn health and care use
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, NHS Lanarkshire, Dundee Leisure and Culture
- Responsible party
- Sponsor
- Investigators
- Andrew B Kerr, PhD, Study director, University of Strathclyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928285
- Sponsor's protocol ID
- UoS_CROFTERS_Kerr2025
- Acronym
- CROFTERS
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the outcomes of the implementation study including interview transcipts and outcome measures
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Rollout of Technology Enriched Rehabilitation After Stroke: An Implementation Study
- ClinicalTrials.gov ID
- NCT06928285
- Acronym / sponsor ID
- CROFTERS / UoS_CROFTERS_Kerr2025
- Conditions
- Stroke
- Keywords
- rehabilitation, technology, implementation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of StrathclydeUniversity, hospital or other
- Collaborators
- NHS Lothian, NHS Lanarkshire, Dundee Leisure and Culture
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The minimum guideline recommendations for rehabilitation after stroke are not being met. This compromises individual recovery and increasing the global burden of disability. A multi-technology solution, co-created with people living with stroke, has been shown to be feasible in both sub-acute and chronic populations but has not been implemented as an integrated rehabilitation service.
The aim of this implementation study is to assess the ability of a technology enriched model of rehabilitation to deliver guideline recommendations in a range of NHS and local authority settings that provide rehabilitation services to stroke survivors at different stages of their recovery. The findings will be used to co-create a scalable, adaptable, and sustainable model that meets rehabilitation guidelines.
Detailed description
A recently completed pilot study (NCT05981729) demonstrated the feasibility of our multi-technology circuit based model of rehabilitation in an acute NHS stroke unit (UHW, NHS Lanarkshire). The key findings were that the model delivered an average of 52 minutes of additional rehabilitation every day, without any safety concerns and with supervision provided by rehabilitation assistants. Importantly for future implementation the participating patients and ward staff were all very positive about the novel approach. The challenge now is to translate these positive findings into a sustainable national solution that maintains fidelity to the key parameters of evidence-based rehabilitation (personalised, high intensity, and enriched environment) and can be adopted by diverse service providers (NHS, Local Authority, and medical charities) across various settings, to support people through their whole recovery journey.
Aim To develop an acceptable and sustainable implementation model of technology enriched rehabilitation after stroke that sustainably delivers NICE (National Institute for Clinical Effectiveness) guideline recommendations in a range of rehabilitation settings and phases of recovery after stroke.
Design This is an implementation study using a mixed methods approach to assess technology enriched rehabilitation gyms across a network of NHS, local authority and 3rd sector funded rehabilitation services. Part of the implementation study will involve gathering preliminary evidence of efficacy through comparison with a control group matched for age and stroke through a data linkage project (eDRIS, Data Scotland).
Locations Four locations have agreed to participate, they represent different stages of recovery after stroke, from acute illness (University Hospital Wishaw, Wishaw, UK) to community care (Blantyre Life, Blantyre, UK) and Edinburgh Community Stroke Service, Edinburgh, UK) and long-term maintenance (Olympia leisure centre, Dundee, UK). At one location (Edinburgh) the study will also test whether a higher dose of rehabilitation can be delivered within current resources including participant tolerance and what resources are required to maintain a high dose delivery.
Participants All participants will have a diagnosis of stroke (physician diagnosed) and be suitable for rehabilitation. Specific eligibility criteria, such as time since stroke, will vary across the locations and are detailed later.
Intervention This will be delivered by the local teams of suitably qualified (e.g. physiotherapists) staff following training from the Strathclyde team.
Intervention parameters Frequency: at least twice a week Intensity: Always sub-maximal. Determined by the amount of time spent in each activity and (where possible) the number of movements (e.g. steps on treadmill) performed Time: 2 hours max with activities varied between seated and standing Total duration: 8 weeks
Content
The TERG intervention has been described in general terms in recent publications (Kerr, Grealy et al. 2021, Kerr, Keogh et al. 2023) and is detailed in a comprehensive manual which will be used for training and to improve fidelity. The key elements are described below:
Once consent has been taken and outcome measures have been recorded each participant should be supported in setting three personal goals. Some training will be provided around effective goal setting. These, together with the initial outcome measures, will be used to structure an initial training programme that will be reviewed regularly (every 2 weeks). The programme will only use the technology listed below and individuals should be trained (as much as possible) to use the equipment on their own, with physical assistance and support provided by the supervising staff.
Rehabilitation equipment and purpose:
- Treadmill with adjustable walking harness system. Purpose: Gait and balance training
- Large, height adjustable, computer tablet with digital health apps. Purpose: Communication and cognitive training performed in standing or sitting
- GripAble hand trainer. Purpose: Upper limb training and cognitive training
- Mirror Therapy. Purpose: Motor priming \& upper limb training
- Power assisted Seated rower. Purpose: General exercise, aerobic, strength, flexibility
- Power assisted Cross cycle trainer. Purpose: General exercise, aerobic, strength, flexibility
- Power assisted Seated climber. Purpose: General exercise, aerobic, strength, flexibility
- Power assisted bike: Purpose: General exercise, aerobic, strength, flexibility
- VR headset; Purpose: Upper limb and balance upper limb co-ordination and balance
On completion of the 8 week programme outcome measures will be repeated and participants will be interviewed by a researcher not involved in the programme delivery to understand the user experience.
Data collected
- Participant attendance (number sessions attended) and engagement (movements performed) with activities.
- Incidence of safety events (adverse events)
- Interviews with staff and participants
- Delivery costs (staff and equipment)
- Standard measures of mobility (10 mwt, five times sit to stand), communication and patient reported outcomes on function (Rivermead Mobility Index) and quality of life (Stroke Impact Scale). These will be recorded before the programme begins and immediately after completion.
- Health and Care costs for 6 months after intervention through a data linkage project
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Implementation study assessing; 1. ability to sustainably deliver NICE (National Institute for Clinical Effectiveness, UK) recommendations for rehabilitation after stroke (intensity and dose) 2. Response from participants including changes to mobility, communication and impact on life. This will include a data linkage control group with dat aopn health and care use
| Arm | Type | Receives |
|---|---|---|
| Technology enriched rehabilitation: Intervention | Experimental | Other: Technology Enriched RehabilitationPeople well enough to exercise lightly but living with motor impairment following a stroke will attend a personalised circuit based programme in a technology enriched rehabilitation gym with exercise and activities structured around their motor, communication and cognitive impairments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of stroke
- Currently well
- Suitable for rehabilitation (motor/ciommunication and or/cognitive impairment(
- Able to attend the programme for two hours at least twice a week
- Able to follow instructions in English and follow provide verbal and/or written feedback
Key exclusion criteria (4 listed)
- Absolute contradictions to physical activity
- Recent (6 weeks) deterioration in health
- Change in medication
- Currently unwell
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology Enriched RehabilitationThe intervention is an 8-week long rehabilitation programme delivered entirely through technology, including virtual reality (immersed and non-immersed), treadmills, weight suspension and movement resistance, and power assistance equipment located in a gym-like space on a university campus. Individual programs are designed, supervised, and reviewed by a physiotherapist using principles of intensity, feedback, cognitive engagement, and aerobic activity to address the goals identified by the participant and scores from outcome measures at baseline. Participants should attend a minimum of two times per week and can more frequently for the two hour group based circuit class. | Other | Technology enriched rehabilitation: Intervention |
Primary outcome
10-meter walk test (10mWT)
Time frame: Three time points; 1) Two weeks before intervention starts at the initial induction meeting,2) immediately before the intervention, and 4) immediately after intervention ends
Time to walk 10 metres
Five times sit to stand movement
Time frame: Three time points; 1) Two weeks before intervention starts, at the induction meeting,2) immediately before the intervention and 3) immediately after intervention ends
Time to complete five sit to stand movements safely.
2 secondary outcomes
Stroke Impact Scale
Time frame: Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends
Action Research Arm Test (ARAT)
Time frame: Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Yes. We will share the outcomes of the implementation study including interview transcipts and outcome measures
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Milena Sklachetka Research Physiotherapist, M.Sc. contact
Andrew B Kerr, PhD study director
University of Strathclyde
Questions about this trial
What is this clinical trial studying?
A study testing Technology Enriched Rehabilitation in people with Stroke, run by University of Strathclyde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew B Kerr, PhD (+441415482855 ext. 2855, a.kerr@strath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-meter walk test (10mWT) (time frame: Three time points; 1) Two weeks before intervention starts at the initial induction meeting,2) immediately before the intervention, and 4) immediately after intervention ends). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.