MiGo Tracker Remote Monitoring of Home Exercise After Stroke

Part of paid clinical trials in Downey, California.

Sponsor
Flint Rehabilitation Devices, LLC
Study ID
NCT06752707
Status
Recruiting

Conditions

  • Subacute Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MiGo Tracker — DEVICE
    Perform home exercise sessions while wearing MiGo Tracker device that logs exercise data.
  • Conventional home exercise program — OTHER
    Exercise following printed sheets or booklet

Study Details

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.

Key Dates

Start date
Jun 11, 2025
Status verified
Jul 2025
Primary completion
Mar 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Upper Extremity Fugl-Meyer from Baseline [ Time Frame: Baseline and 3 months post stroke ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rancho Research Institute, IncDowneyCalifornia90242
Nicole Bayus
562-385-7049
Susan Shaw, MD (PRINCIPAL_INVESTIGATOR)

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