FitMi PD Home Therapy for Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: FitMi PD

• Registration Number: NCT05655377
• Lead Sponsor: Flint Rehabilitation Devices, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-31
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-19
• Results First Submitted: 2023-01-18
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Results First Posted: 2023-02-17
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
At home exercise therapy with FitMi PD	FitMi PD	Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Successfully Used FitMi PD to Exercise at Home	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.

Secondary Outcome Measures

Name	Time	Method
Mini Mental State Examination (MMSE)	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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States