Recruiting

MiGo Tracker

Sponsor:

Flint Rehabilitation Devices, LLC

Code:

NCT06752707

Conditions

Subacute Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MiGo Tracker

Conventional home exercise program

Study Details

Brief summary:

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.

Conditions

Subacute Stroke

Study ID

NCT06752707

Start date

Jun 11, 2025

Status verified date

Jul, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

MiGo Tracker

Perform home exercise sessions while wearing MiGo Tracker device that logs exercise data.

Conventional home exercise program

Exercise following printed sheets or booklet

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ian M Russell, PhD

3392232676irussell@flintrehab.com

Daniel Zondervan, PhD

949-313-7322dzondervan@flintrehab.com

Locations

Rancho Research Institute, Inc

Recruiting

Downey, California, United States, 90242

Contacts

Nicole Bayus

562-385-7049NicoleB@ranchoresearch.org

Principal Investigator:

Susan Shaw, MD

More Information

Sponsor

Flint Rehabilitation Devices, LLC

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Keywords

  • Remote Therapeutic Monitoring
  • Stroke
  • Home Exercise Therapy
  • MiGo Tracker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Flint Rehabilitation Devices, LLC on 2025-07-16.