- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06787768
Technology Enriched Rehabilitation Gym (TERG)
User Experience of a Technology Based Rehabilitation Programme
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Glasgow, United Kingdom, G44 3RL
- University of Strathclyde
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Absolute contradictions to physical activity
- Recent (6 weeks) deterioration in health
- Change in medication
- Currently unwell
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Chronic stroke survivors
People well enough to exercise lightly but living with motor impairment following a stroke at least 12 months previously
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Time to walk 10 metres
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Milena Sklachetka, BSc, University of Strathclyde
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UStrathclyde_UEC20/08 Kerr
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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