EICHORCondition: Subacute Stroke · Sponsor: Flint Rehabilitation Devices, LLC
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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.
This description comes directly from the study's public registry record.
Ian M Russell, PhD · 3392232676 · irussell@flintrehab.com
Daniel Zondervan, PhD · 949-313-7322 · dzondervan@flintrehab.com
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Rancho Research Institute, Inc | Downey, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06752707