FitMi Plus Home Therapy for Stroke Patients

• ClinicalTrials.gov Identifier: NCT03935425
• Recruitment Status: Completed
• First Posted: May 2, 2019
• Last Update Posted: February 24, 2023
• Sponsor: Flint Rehabilitation Devices, LLC
• Collaborators: University of California, Irvine; Rancho Research Institute, Inc.
• Information provided by (Responsible Party): Flint Rehabilitation Devices, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Stroke	Device: FitMi Plus; Device: FitMi Basic	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke
• Actual Study Start Date: November 29, 2021
• Actual Primary Completion Date: October 31, 2022
• Actual Study Completion Date: December 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Motor Activity Log [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment. ]
   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.

Secondary Outcome Measures :

1. Change in Upper Extremity Fugl-Meyer [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment. ]
   A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks.
2. Action Research Arm Test [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment. ]

   A 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).

   Performance on each item is rated on a 4-point ordinal scale ranging from:

   3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty

   1) Performs test partially 0) Can perform no part of test

3. Modified Ashworth Spasticity Scale [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment ]
   Tests resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 6 choices.
4. Visual Analog Pain Scale [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment. ]
   The Visual Analog Pain Scale is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The scale ranges from 0) "no pain" to 10) "worst possible, unbearable pain"
5. Wearable Activity Tracking [ Time Frame: Baseline, One-Month Post-Treatment. ]
   Participants wear a custom-designed wrist-mounted actigrapher (the MiGo, which uses wrist-worn accelerometers to monitor functional use of the upper extremity activity) for a 24 hour period to assess changes in functional activity levels.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

Rancho Research Institute, Inc

Downey, California, United States, 90242

Human Neuroperformance Laboratory at University of California Irvine

Irvine, California, United States, 926170000

Sponsors and Collaborators

Flint Rehabilitation Devices, LLC

University of California, Irvine

Rancho Research Institute, Inc.

Investigators

• Principal Investigator: David Reinkensmeyer, PhD; University of California, Irvine
• Principal Investigator: Susan Shaw, MD; Rancho Research Institute, Inc.

More Information

• Responsible Party: Flint Rehabilitation Devices, LLC, Vice President
• ClinicalTrials.gov Identifier: NCT03935425
• Other Study ID Numbers: 1R44HD097803-01 ( U.S. NIH Grant/Contract )
• First Posted: May 2, 2019
• Last Update Posted: February 24, 2023
• Last Verified: February 2023

• 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

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases