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OpenTrials
Completed

NCT Number: NCT05655377

FitMi PD Home Therapy for 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90089, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FitMi PD

Device

Exercise using the motion sensing devices and a tablet computer

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Flint Rehabilitation Devices, LLC

Industry

Collaborators

  • University of Southern California

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2022
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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