NCT05655377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
2 months until next milestone

Results Posted

Study results publicly available

February 17, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

December 7, 2022

Results QC Date

January 18, 2023

Last Update Submit

February 15, 2023

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mini Mental State Examination (MMSE)

    Baseline

Study Arms (1)

At home exercise therapy with FitMi PD

EXPERIMENTAL

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

Device: FitMi PD

Interventions

FitMi PDDEVICE

Exercise using the motion sensing devices and a tablet computer

At home exercise therapy with FitMi PD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild to moderate PD (Hoehn and Yahr stage I to III)
  • Mini-Mental State Examination greater than 28

You may not qualify if:

  • Age less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Ian Russell
Organization
Flint Rehabilitation Devices
irussell@flintrehab.com
9496670140

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 19, 2022

Study Start

March 1, 2021

Primary Completion

October 15, 2022

Study Completion

October 31, 2022

Last Updated

February 17, 2023

Results First Posted

February 17, 2023

Record last verified: 2023-02

Locations

US(1)