FitMi PD Home Therapy for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05655377
• Other study ID #: 1R43AG071253-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: February 2023
• Source: Flint Rehabilitation Devices, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 31, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• FitMi PD
Exercise using the motion sensing devices and a tablet computer

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Flint Rehabilitation Devices, LLC	University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately Post-Treatment, an average of 3 weeks
Secondary	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	Baseline