NCT06752707 · Flint Rehabilitation Devices, LLC
MiGo Tracker Remote Monitoring of Home Exercise After Stroke
What this study is about
This project will determine the safety and effectiveness of a MiGo Tracker RTM program in a randomly assigned 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).
View original scientific description
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.
Interventions
DEVICE
MiGo Tracker
Perform home exercise sessions while wearing MiGo Tracker device that logs exercise data.
OTHER
Conventional home exercise program
Exercise following printed sheets or booklet
Primary outcome measures
Change in Upper Extremity Fugl-Meyer from Baseline
Time frame: Baseline and 3 months post stroke
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation, balance, joint range of motion and joint pain in patients with post-stroke hemiplegia. A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks. Minimum value = 0, maximum value = 66, higher scores = better outcome
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Downey, California
Collaborators
National Institute on Aging (NIA), Rancho Research Institute, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2025 · Source of record for eligibility and locations