N/A
Completed N=50
FitMi Plus Home Therapy for Stroke Patients
Cerebral Stroke
Source: ClinicalTrials.gov NCT03935425 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Change in Motor Activity Log — 0.60; 0.40; 0.64; 0.44 score on a scale — p=0.11
Summary
The investigators will investigate the efficacy of a newly developed functional exercise device (FitMi Plus) for people in the chronic stage after a stroke compared to the FitMi Basic (i.e. without functional exercises). FitMi Plus combines objects commonly used during activities of daily living with sensors that can track and record the patient's direction and degree of movement as they perform specific functional tasks described on a computer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Motor Activity Log |
0.60; 0.40; 0.64; 0.44 | 0.11 |
| SECONDARY Change in Upper Extremity Fugl-Meyer |
2.0; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Experienced 1 or more strokes >6 months prior to enrollment
- Upper Extremity Fugl-Meyer Score >=15 and <=55 out of 66
- Absence of moderate to severe upper extremity pain (<= 4 out of 10 on the visual-analog pain scale)
- Ability to understand the instructions to operate FitMi products
Exclusion Criteria
- Lack of concurrent severe medical problems
- Lack of visual deficits
- Lack of severe neglect or apraxia
- No concurrent enrollment in another therapy study
Data sourced from ClinicalTrials.gov (NCT03935425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.