FitMi PD Home Therapy for Parkinson's Disease

February 15, 2023 updated by: Flint Rehabilitation Devices, LLC

FitMi PD: an Affordable Home Therapy Device for Individuals With Parkinson's Disease

The investigators will run an at-home usability study of a newly developed home exercise device (FitMi PD) for individuals with Parkinson's disease. FitMi PD uses embedded sensors that can track and record the user's direction and degree of movement while performing exercises described on a computer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild to moderate PD (Hoehn and Yahr stage I to III)
  • Mini-Mental State Examination greater than 28

Exclusion Criteria:

  • Age less than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: At home exercise therapy with FitMi PD
Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period.
Device: FitMi PD
Exercise using the motion sensing devices and a tablet computer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants That Successfully Used FitMi PD to Exercise at Home
Time Frame: Immediately Post-Treatment, an average of 3 weeks
Number of participants who were successfully able to use the device at home to exercise over 3 week period.
Immediately Post-Treatment, an average of 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State Examination (MMSE)
Time Frame: Baseline

A screening tool for assessing cognitive impairment. A maximum possible score of 30 is used to provide a picture of an individuals' present cognitive performance. A score of < 24 is the generally accepted cutoff indicating the presence of cognitive impairment.

Levels of impairment have been classified as:

None: score = 24-30 Mild: score = 18-24 Severe: score = 0-17
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Flint Rehabilitation Devices, LLC

Collaborators

University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R43AG071253-01 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on FitMi PD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe