Trial Outcomes & Findings for FitMi PD Home Therapy for Parkinson's Disease (NCT NCT05655377)

Results Overview

Number of participants who were successfully able to use the device at home to exercise over 3 week period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Immediately Post-Treatment, an average of 3 weeks

Results posted on

2023-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	At Home Exercise Therapy With FitMi PD Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period. FitMi PD: Exercise using the motion sensing devices and a tablet computer
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	At Home Exercise Therapy With FitMi PD Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period. FitMi PD: Exercise using the motion sensing devices and a tablet computer
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	At Home Exercise Therapy With FitMi PD n=9 Participants Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period. FitMi PD: Exercise using the motion sensing devices and a tablet computer
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=9 Participants
Age, Categorical >=65 years	3 Participants n=9 Participants
Age, Continuous	57.11 years STANDARD_DEVIATION 10.4 • n=9 Participants
Sex: Female, Male Female	5 Participants n=9 Participants
Sex: Female, Male Male	4 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	At Home Exercise Therapy With FitMi PD n=9 Participants Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period. FitMi PD: Exercise using the motion sensing devices and a tablet computer
Number of Participants That Successfully Used FitMi PD to Exercise at Home	7 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	At Home Exercise Therapy With FitMi PD n=9 Participants Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period. FitMi PD: Exercise using the motion sensing devices and a tablet computer
Mini Mental State Examination (MMSE)	30 score on a scale Standard Deviation 0.44

Adverse Events

At Home Exercise Therapy With FitMi PD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ian Russell

Flint Rehabilitation Devices

Phone: 9496670140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place