Clinical trial NCT06787768: Technology Enriched Rehabilitation Gym
Official title: User Experience of a Technology Based Rehabilitation Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Keywords: Rehabilitation
Technology
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 10-meter walk test (10mWT)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Strathclyde
Study officials:
affiliation: University of Strathclyde
name: Milena Sklachetka, BSc
role: PRINCIPAL_INVESTIGATOR
References: