FitMi Plus Home Therapy for Stroke Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Stroke
• Intervention / Treatment: Device: FitMi Plus; Device: FitMi Basic

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Zondervan, PhD; Phone Number: 949-313-7322; Email: dzondervan@flintrehab.com

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Rancho Research Institute, Inc
    • Irvine, California, United States, 926170000
      • Human Neuroperformance Laboratory at University of California Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Device: FitMi Basic; A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Flint Rehabilitation Devices, LLC
• Collaborators: University of California, Irvine; Rancho Research Institute, Inc.
• Investigators: Principal Investigator: Susan Shaw, MD, Rancho Research Institute, Inc.; Principal Investigator: David Reinkensmeyer, PhD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 1R44HD097803-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No