FitMi Plus Home Therapy for Stroke Patients

Not Applicable

Completed

• Conditions: Cerebral Stroke
• Interventions: Device: FitMi Plus; Device: FitMi Basic

• Registration Number: NCT03935425
• Lead Sponsor: Flint Rehabilitation Devices, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-02
• Study Start: 2021-11-29
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31
• Results First Submitted: 2023-12-31
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Results First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FitMi Plus	FitMi Plus	Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.
FitMi Basic	FitMi Basic	Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Change in Motor Activity Log	Baseline and One-Month Post-Treatment, at seven weeks	A self-reported measure of the quality of movement and amount of use of the impaired upper extremity across a set of activities of daily living. Minimum value = 0, maximum value = 5, higher scores = better outcome

Secondary Outcome Measures

Name	Time	Method
Change in Upper Extremity Fugl-Meyer	Baseline and One-Month Post-Treatment, at seven weeks	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

Trial Locations

Locations (2)

Rancho Research Institute, Inc; 🇺🇸 Downey, California, United States

Human Neuroperformance Laboratory at University of California Irvine; 🇺🇸 Irvine, California, United States