Stroke Circulatory System
Conditions
Interventions
This trial will use a parallel group, non-blinded, randomized, feasibility methodology comparing the OnTrack™ system plus standard care versus standard care alone for the treatment of patients with a
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. All participants in the study will have had a stroke diagnosis with any associated arm weakness in the previous 6 months, and be receiving rehabilitation care from the NHS at the point of recruitment 3. Participants must be able to provide informed consent 4. Participants must be English speakers with a reliable communication method and be able to read short messages on screen
Exclusion criteria
Exclusion criteria: Potential participants who at the time of recruitment (or during participation) present with any of the following will be excluded: 1. Unstable medical condition 2. Self-reported ‘severe’ pain in the arm affected either at rest or during movement 3. Severe oedema in the arm affected by their stroke, judged by the consenting therapist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of trial procedures will be assessed via analysis of: 1. Patient recruitment (at the end of the trial) 2. Patient retention – including treatment-specific retention (at the end of the trial) Intervention feasibility will be assessed via analysis of: 1. System Usability Scale (SUS) - this scale is a reliable tool for measuring usability and consists of a 10-item Likert Scale questionnaire (Strongly Agree to Strongly Disagree). This questionnaire will be completed by patient participants and therapist participants at weeks 6 and 12. 2. Patient and therapist interviews (conducted at the end of the intervention period) Intervention fidelity will be assessed via analysis of: 1. Patient compliance with the prescribed intervention use (number of days that the patient activated/switched on the OnTrack™ system) – this will be assessed at the end of the intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary evidence of clinical effectiveness will be assessed via: 1. Arm function measured using Motor Activity Log-14 at week 0, week 6 and week 12 2. Confidence for functional performance and aspects of self-management relevant for individuals recovering from stroke, measured using the Stroke Self-Efficacy Questionnaire (SSEQ) at week 0, week 6 and week 12 3. Disability and dependence in individuals who have suffered from a stroke or other neurological condition, measured using the Modified Rankin Scale at week 0, week 6 and week 12 4. Health-related quality of life measured using EQ-5D-5L at week 0, week 6 and week 12 | — |
Countries
England, United Kingdom
Outcome results
None listed