StrokeTERGNCT06787768
Technology Enriched Rehabilitation Gym
A study testing Technology Enriched Rehabilitation Gym in people with Stroke and Rehabilitation, run by University of Strathclyde at 1 site in United Kingdom.
Trial summary
The department (Biomedical Engineering, University of Strathclyde) co-creates rehabilitation technology. To improve the quality of the feedback the investigators have set up a programme of rehabilitation supervised by qualified therapists (physical therapists, occupational therapists and speech therapists) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Rehabilitation
- What is being tested?
- Technology Enriched Rehabilitation Gym
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 at least 12 months previously
- Currently well
- Not currently receiving rehabilitation
- 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
1 site in 1 country.
United Kingdom1 site
University of Strathclyde
Glasgow, Glasgow, G44 3RL
About this study
Official title: User Experience of a Technology Based Rehabilitation Programme
The department (Biomedical Engineering, University of Strathclyde) co-creates rehabilitation technology. To improve the quality of the feedback the investigators have set up a programme of rehabilitation supervised by qualified therapists (physical therapists, occupational therapists and speech therapists) and delivered entirely through technology. This tests the feasibility of the overall approach as well as helping develop specific pieces of equipment.
Read the detailed description
A key area of research activity within the Biomedical Engineering Dept. is the development of rehabilitation technologies to support the recovery of function in people with movement disorders such as stroke, cerebral palsy and spinal chord injury. A critical part of the design process for these technologies is the close involvement of users from concept through to prototype testing. Despite significant levels of investment rehabilitation technologies continue to experience barriers to adoption among private users and the health service with issues such as cost, usability, portability and accessibility cited as factors. Adopting a partnership approach towards the development of these technologies would address these issues.
Engagement between technology designers and users is typically ad-hoc and project specific with users invited to attend design concept workshops or "try out" sessions with a technology in the prototype stages of its development. While these experiences are certainly useful they are unable to provide the in-depth information needed to inform the translation of these technologies into practice, neither do they provide the interactions capable of generating new ideas.
The aim of this project is to test the feasibility of a technology enriched rehabilitation programme in people living with stroke and gather user feedback on specific technology. The programme offers professionally supervised (therapists) access to an existing suite of commercially available and prototype rehabilitation technologies for 8 weeks, 2-5 times a week. Such an arrangement provides a critical source of feedback as well as creating considerable opportunity for new ideas to emerge, both for specific technologies and models of delivery. Specifically it would:
- Provide stroke survivors with time limited, professionally supervised, access to an integrated suite of rehabilitation technologies.
- Enable data to be collected from users on their response to the intervention. This would include:
- Demographics (age, gender)
- Stroke detail (number of strokes and time since last stroke).
- Stroke related impairments in mobility, speech and cognition
- Co-morbidities (number and nature).
- Change in impairments as a response to the rehabilitation intervention
- Collect data on their interactions and general experiences with the rehabilitation technologies.
This would include a recorded interview at the end of their participation covering opinions on specific technologies and general views on the use of technology in the rehabilitation process including access. It will also conduct focus groups (n=5 to 8) to explore the use of goal setting and the development of an educational package to help individuals continue their rehabilitation after the programme completes.
- Conditions
- Stroke, Rehabilitation
- Being tested
- Technology Enriched Rehabilitation Gym
- Keywords
- Rehabilitation, Technology
- 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 Rehabilitation GymOther
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 attend a minimum of two times per week and can attend daily for the two hour group based circuit class.
| Study group | Role | What they receive |
|---|---|---|
| Chronic stroke survivors | Experimental | People well enough to exercise lightly but living with motor impairment following a stroke at least 12 months previously Receives: Other: Technology Enriched Rehabilitation Gym |
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: Four time points; 1) Two weeks before intervention starts,2) immediately before the intervention, 3) week 4 (halfway way through intervention) and 4) 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 posted22 Jan 2025
- Study start1 Sep 2022
- Primary completion1 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Two baselines measures of function (mobility) separated by 14 days recorded at least 1 week before the intervention. Intervention is an 8 week rehabilitation programme delivered with technology. Measures of function repeated immediately after intervention
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milena Sklachetka, BSc, Principal investigator, University of Strathclyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787768
- Sponsor's protocol ID
- UStrathclyde_UEC20/08 Kerr
- Acronym
- TERG
- Status last verified
- Jan 2025
- First submitted
- 14 Aug 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kerr A, Grealy M, Slachetka M, Tse D, Rowe P. Intensive, Multi-Technology Rehabilitation Programme for Chronic Stroke Survivors: Outcomes of a Phase I Single-Arm Repeated-Measures Study. Physiother Res Int. 2026 Oct;31(4):e70321. doi: 10.1002/pri.70321.
PubMed 42615415
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Experience of a Technology Based Rehabilitation Programme
- ClinicalTrials.gov ID
- NCT06787768
- Acronym / sponsor ID
- TERG / UStrathclyde_UEC20/08 Kerr
- Conditions
- Stroke, Rehabilitation
- Keywords
- Rehabilitation, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of StrathclydeUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 22 Jan 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 department (Biomedical Engineering, University of Strathclyde) co-creates rehabilitation technology. To improve the quality of the feedback the investigators have set up a programme of rehabilitation supervised by qualified therapists (physical therapists, occupational therapists and speech therapists) and delivered entirely through technology. This tests the feasibility of the overall approach as well as helping develop specific pieces of equipment.
Detailed description
A key area of research activity within the Biomedical Engineering Dept. is the development of rehabilitation technologies to support the recovery of function in people with movement disorders such as stroke, cerebral palsy and spinal chord injury. A critical part of the design process for these technologies is the close involvement of users from concept through to prototype testing. Despite significant levels of investment rehabilitation technologies continue to experience barriers to adoption among private users and the health service with issues such as cost, usability, portability and accessibility cited as factors. Adopting a partnership approach towards the development of these technologies would address these issues.
Engagement between technology designers and users is typically ad-hoc and project specific with users invited to attend design concept workshops or "try out" sessions with a technology in the prototype stages of its development. While these experiences are certainly useful they are unable to provide the in-depth information needed to inform the translation of these technologies into practice, neither do they provide the interactions capable of generating new ideas.
The aim of this project is to test the feasibility of a technology enriched rehabilitation programme in people living with stroke and gather user feedback on specific technology. The programme offers professionally supervised (therapists) access to an existing suite of commercially available and prototype rehabilitation technologies for 8 weeks, 2-5 times a week. Such an arrangement provides a critical source of feedback as well as creating considerable opportunity for new ideas to emerge, both for specific technologies and models of delivery. Specifically it would:
- Provide stroke survivors with time limited, professionally supervised, access to an integrated suite of rehabilitation technologies.
- Enable data to be collected from users on their response to the intervention. This would include:
- Demographics (age, gender)
- Stroke detail (number of strokes and time since last stroke).
- Stroke related impairments in mobility, speech and cognition
- Co-morbidities (number and nature).
- Change in impairments as a response to the rehabilitation intervention
- Collect data on their interactions and general experiences with the rehabilitation technologies.
This would include a recorded interview at the end of their participation covering opinions on specific technologies and general views on the use of technology in the rehabilitation process including access. It will also conduct focus groups (n=5 to 8) to explore the use of goal setting and the development of an educational package to help individuals continue their rehabilitation after the programme completes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two baselines measures of function (mobility) separated by 14 days recorded at least 1 week before the intervention. Intervention is an 8 week rehabilitation programme delivered with technology. Measures of function repeated immediately after intervention
| Arm | Type | Receives |
|---|---|---|
| Chronic stroke survivors | Experimental | Other: Technology Enriched Rehabilitation GymPeople well enough to exercise lightly but living with motor impairment following a stroke at least 12 months previously |
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 at least 12 months previously
- Currently well
- Not currently receiving rehabilitation
- 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 Rehabilitation GymThe 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 attend a minimum of two times per week and can attend daily for the two hour group based circuit class. | Other | Chronic stroke survivors |
Primary outcome
10-meter walk test (10mWT)
Time frame: Four time points; 1) Two weeks before intervention starts,2) immediately before the intervention, 3) week 4 (halfway way through intervention) and 4) immediately after intervention ends
Time to walk 10 metres
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 42615415Kerr A, Grealy M, Slachetka M, Tse D, Rowe P. Intensive, Multi-Technology Rehabilitation Programme for Chronic Stroke Survivors: Outcomes of a Phase I Single-Arm Repeated-Measures Study. Physiother Res Int. 2026 Oct;31(4):e70321. doi: 10.1002/pri.70321.
Related trials for Stroke
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Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
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A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
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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. This study is not recruiting at the moment.
Milena Sklachetka, BSc principal investigator
University of Strathclyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology Enriched Rehabilitation Gym in people with Stroke and Rehabilitation, run by University of Strathclyde at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-meter walk test (10mWT) (time frame: Four time points; 1) Two weeks before intervention starts,2) immediately before the intervention, 3) week 4 (halfway way through intervention) and 4) immediately after intervention ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787768, which also lists 1 linked publication.
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 22 Jan 2025.