Skip to main content
OpenTrials
Completed

NCT Number: NCT03935425

FitMi Plus Home Therapy for Stroke Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Research Institute, Inc, Downey, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Basic

Device

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

Primary outcomes

  1. Change in Motor Activity Log

    Time frame: 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 outcomes

  1. Change in Upper Extremity Fugl-Meyer

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Flint Rehabilitation Devices, LLC

Industry

Collaborators

  • Rancho Research Institute, Inc.
  • University of California, Irvine

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 2, 2019
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.