Viewing Study NCT06787768


Ignite Creation Date: 2025-12-24 @ 5:59 PM
Ignite Modification Date: 2025-12-27 @ 6:41 AM
Study NCT ID: NCT06787768
Status: COMPLETED
Last Update Posted: 2025-01-22
First Post: 2024-08-14
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Technology Enriched Rehabilitation Gym
Sponsor: University of Strathclyde
Organization:

Study Overview

Official Title: User Experience of a Technology Based Rehabilitation Programme
Status: COMPLETED
Status Verified Date: 2025-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TERG
Brief 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 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:

1. Provide stroke survivors with time limited, professionally supervised, access to an integrated suite of rehabilitation technologies.
2. 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
3. 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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: