FitMi Plus Home Therapy for Stroke Patients

NCT03935425 | Completed Results FDA Device

• 1 other identifier: 1R44HD097803-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Upper Extremity Fugl-Meyer

  Baseline and One-Month Post-Treatment, at seven weeks

Study Arms (2)

FitMi Plus

EXPERIMENTAL

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

FitMi Basic

ACTIVE COMPARATOR

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

Interventions

FitMi Plus DEVICE

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 Plus

FitMi Basic DEVICE

A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.

FitMi Basic

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Flint Rehabilitation Devices, LLC: lead
• University of California, Irvine: collaborator
• Rancho Research Institute, Inc.: collaborator

Study Sites (2)

Rancho Research Institute, Inc

Downey, California, 90242, United States

Location

Human Neuroperformance Laboratory at University of California Irvine

Irvine, California, 926170000, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Daniel Zondervan
• Organization: Flint Rehab

dzondervan@flintrehab.com

9493137322

Study Officials

• David Reinkensmeyer, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Susan Shaw, MD

  Rancho Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 2, 2019
• Study Start: November 29, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Locations

US (2)