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| Name | Class |
|---|---|
| University of Southern California | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FitMi PD | Device | Exercise using the motion sensing devices and a tablet computer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Immediately Post-Treatment, an average of 3 weeks |
|
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Russell | Flint Rehabilitation Devices | 9496670140 | irussell@flintrehab.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2023 | Jan 18, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2023 | Jan 18, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Baseline |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |