FitMi Plus Home Therapy for Stroke Patients

Completed · Not applicable

Conditions studied: Cerebral Stroke

In brief

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.

Key facts

Study ID

NCT03935425

Run by

Flint Rehabilitation Devices, LLC

People needed

50

Starts

2021-11-29

Expected to finish

2022-12-31

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Lack of concurrent severe medical problems
• Lack of visual deficits
• Lack of severe neglect or apraxia
• No concurrent enrollment in another therapy study

Where it is running

• Rancho Research Institute, Inc — Downey, California, United States
• Human Neuroperformance Laboratory at University of California Irvine — Irvine, California, United States

Full record on ClinicalTrials.gov

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