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FitMi PD Home Therapy for Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FitMi PD
Sponsored by
Flint Rehabilitation Devices, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

At home exercise therapy with FitMi PD

Arm Description

Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period.

Outcomes

Primary Outcome Measures

Number of Participants That Successfully Used FitMi PD to Exercise at Home
Number of participants who were successfully able to use the device at home to exercise over 3 week period.

Secondary Outcome Measures

Mini Mental State Examination (MMSE)
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

Full Information

First Posted
December 7, 2022
Last Updated
February 15, 2023
Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT05655377
Brief Title
FitMi PD Home Therapy for Parkinson's Disease
Official Title
FitMi PD: an Affordable Home Therapy Device for Individuals With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
University of Southern California

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
At home exercise therapy with FitMi PD
Arm Type
Experimental
Arm Description
Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period.
Intervention Type
Device
Intervention Name(s)
FitMi PD
Intervention Description
Exercise using the motion sensing devices and a tablet computer
Primary Outcome Measure Information:
Title
Number of Participants That Successfully Used FitMi PD to Exercise at Home
Description
Number of participants who were successfully able to use the device at home to exercise over 3 week period.
Time Frame
Immediately Post-Treatment, an average of 3 weeks
Secondary Outcome Measure Information:
Title
Mini Mental State Examination (MMSE)
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Learn more about this trial

FitMi PD Home Therapy for Parkinson's Disease

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