Parkinson Disease
Conditions
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.
Interventions
DEVICEFitMi PD
Exercise using the motion sensing devices and a tablet computer
Sponsors
University of Southern California
Flint Rehabilitation Devices, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Successfully Used FitMi PD to Exercise at Home | 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
| Measure | Time frame | Description |
|---|---|---|
| Mini Mental State Examination (MMSE) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | At Home Exercise Therapy With FitMi PD | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 57.11 years STANDARD_DEVIATION 10.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 9 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: Immediately Post-Treatment, an average of 3 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| At Home Exercise Therapy With FitMi PD | Number of Participants That Successfully Used FitMi PD to Exercise at Home | 7 Participants |
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| At Home Exercise Therapy With FitMi PD | Mini Mental State Examination (MMSE) | 30 score on a scale | Standard Deviation 0.44 |