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NCT05655377

FitMi PD Home Therapy for Parkinson's Disease

Completed NA Results posted Last updated 17 February 2023
What this trial tests

NA trial testing FitMi PD in Parkinson Disease in 9 participants. Completed in 31 October 2022.

Timeline
1 March 2021
Primary endpoint
15 October 2022
31 October 2022

Quick facts

Lead sponsorFlint Rehabilitation Devices, LLC
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment9
Start date1 March 2021
Primary completion15 October 2022
Estimated completion31 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Flint Rehabilitation Devices, LLC — full company profile →

Who can join

18 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants That Successfully Used FitMi PD to Exercise at Home Primary · 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.

GroupValue95% CI
At Home Exercise Therapy With FitMi PD7
Mini Mental State Examination (MMSE) Secondary · 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

GroupValue95% CI
At Home Exercise Therapy With FitMi PD30± 0.44

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Other Flint Rehabilitation Devices, LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05655377.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing