FitMi Plus Home Therapy for Stroke Patients

Cerebral Stroke Clinical Trial

Official title:

FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935425
• Other study ID #: 1R44HD097803-01
• Status: Completed
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Flint Rehabilitation Devices, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

Device:
• FitMi Plus
A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform.
• FitMi Basic
A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.

Locations

Country	Name	City	State
United States	Rancho Research Institute, Inc	Downey	California
United States	Human Neuroperformance Laboratory at University of California Irvine	Irvine	California

Sponsors (3)

Lead Sponsor	Collaborator
Flint Rehabilitation Devices, LLC	Rancho Research Institute, Inc., University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Motor Activity Log	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	Baseline and One-Month Post-Treatment, at seven weeks
Secondary	Change in Upper Extremity Fugl-Meyer	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	Baseline and One-Month Post-Treatment, at seven weeks