MiGo Tracker Remote Monitoring of Home Exercise After Stroke
Purpose
This project will determine the safety and effectiveness of a MiGo Tracker RTM program in a randomized controlled trial with individuals with subacute stroke (N=50). Participants will be randomly assigned to either the MiGo Tracker RTM program (intervention group) or prescription of home exercises with no monitoring (usual care/control group). All participants will still receive usual post-stroke care, including outpatient rehabilitation. The main question this study aims to answer is: Does a MiGo Tracker RTM program lead to significantly greater motor recovery at three-months post stroke than the usual care group. If successful, MiGo Tracker will lead to increased home exercise adherence and improved health outcomes for thousands of individuals following stroke.
Condition
- Subacute Stroke
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Experienced one or more strokes less than one month (30 days) prior - Upper Extremity Fugl-Meyer Score > 5 and <= 55 out of 66 - Absence of moderate to severe pain (<= 4 on the 10 point visual-analog pain scale)
Exclusion Criteria
- age <18 years old - Unable to follow 2-step commands - Other neurological diagnosis (e.g. Parkinson's Disease) - Other severe concurrent medical conditions that may prevent the participants from completing the 3-month study
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Assessor blinded
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MiGo Tracker enabled RTM Program |
Participants will be provided a MiGo Tracker device which will log all home exercise sessions and uploaded to the MiGo-RTM dashboard. The supervising study therapist will conduct weekly phone calls with each participant where they review exercise metrics and assist with any barriers or issues. |
|
|
Active Comparator Conventional Standard of Care |
Participants will be assigned a home exercise regimen designed by a study therapist based on the individual participant's specific goals and abilities. |
|
Recruiting Locations
Downey, California 90242
More Details
- NCT ID
- NCT06752707
- Status
- Recruiting
- Sponsor
- Flint Rehabilitation Devices, LLC