FitMi PD Home Therapy for Parkinson's Disease

NCT ID: NCT05655377

Last Updated: 2023-02-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FitMi PD

Intervention Type DEVICE

Exercise using the motion sensing devices and a tablet computer

Interventions

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FitMi PD

Exercise using the motion sensing devices and a tablet computer

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role collaborator

Flint Rehabilitation Devices, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R43AG071253-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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