NCT06787768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

August 14, 2024

Last Update Submit

January 20, 2025

Conditions

Keywords

RehabilitationTechnology

Outcome Measures

Primary Outcomes (1)

  • 10-meter walk test (10mWT)

    Time to walk 10 metres

    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

Study Arms (1)

Chronic stroke survivors

EXPERIMENTAL

People well enough to exercise lightly but living with motor impairment following a stroke at least 12 months previously

Other: Technology Enriched Rehabilitation Gym

Interventions

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.

Chronic stroke survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Absolute contradictions to physical activity
  • Recent (6 weeks) deterioration in health
  • Change in medication
  • Currently unwell

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Strathclyde

Glasgow, Glasgow, G44 3RL, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Milena Sklachetka, BSc

    University of Strathclyde

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking is used
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2024

First Posted

January 22, 2025

Study Start

September 1, 2022

Primary Completion

December 1, 2024

Study Completion

January 10, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Locations