About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- MiGo Tracker
- Conventional home exercise program
Treatment groups
Sponsors and collaborators
Flint Rehabilitation Devices, LLC
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Rancho Research Institute, Inc.
Collaborator