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The purpose of this study is to evaluate the impact of a smartphone application that delivers at-home therapy exercises on patients' self-management of gait, speech, and dexterity symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Application | Experimental | Subjects will complete at-home allied health therapy exercises delivered through a smartphone application. Subjects will use the application daily for 4 weeks, each daily session takes up to 30 minutes to complete. |
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| Digital Placebo | Placebo Comparator | Subjects will have access to a digital placebo application and continue usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parkinson's Application | Device | The application delivers at-home, tailored allied health exercises (physiotherapy, speech and language therapy, and occupational therapy) for the gait, speech, and manual dexterity symptoms associated with Parkinson's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Velocity (m/s) | Gait velocity on a 10-Meter Walk Test (10MWT) conducted in-clinic. | Baseline, Week 4, Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Step Length (m) | Change in Step length on a 10-Meter Walk Test (10MWT) conducted in-clinic. | Baseline, Week 4, Week 8, Week 12 |
| Step Frequency (steps/min) | Change in Step frequency on a 10-Meter Walk Test (10MWT) conducted in-clinic. |
| Measure | Description | Time Frame |
|---|---|---|
| Average duration (seconds) of sustained vowel phonation | Change in the average duration of sustained vowel phonation on a smartphone-based speech assessment conducted in-clinic. | Baseline, Week 4, Week 8, Week 12 |
| Time taken to complete a smartphone-based 9-Hole Peg Test (seconds) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armistead Williams, MD | Contact | 757-226-0655 | awilliams@mcrmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meridian Clinical Research | Norfolk | Virginia | 23502 | United States |
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| Digital Placebo Application | Device | The application is designed to provide a method of capturing outcome measures without providing access to the therapy exercises. |
|
| Baseline, Week 4, Week 8, Week 12 |
| MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1 | Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is designed to monitor the burden and extent of Parkinson's disease. The MDS-UPDRS is divided into 4 parts: (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. In each part, all items are rated on a scale from 0-4, with higher scores reflecting greater severity. The sum of items 2.1 (Speech) and Part III 3.1 (Speech) will be used to calculate a total score to assess speech abilities. | Baseline, Week 4, Week 8, Week 12 |
| MDS-UPDRS Total Score for Part II Item 2.7 + Part III Item 3.4 + Part III 3.5 | The sum of items 2.7 (handwriting), 3.4 (finger tapping), and 3.5 (hand movements) will be used to calculate a total score to assess manual dexterity. All items are rated on a scale from 0-4, with higher scores reflecting greater severity. | Baseline, Week 4, Week 8, Week 12 |
| MDS-UPDRS Part II Total Score | For MDS-UPDRS Part II (motor experiences of daily living) scores, the scale range for Part II Total Score is 0-52, with higher scores reflecting greater severity. | Baseline, Week 4, Week 8, Week 12 |
| Daily steps | Physical activity will be assessed by the relative change in daily steps recorded by the in-device sensors in the smartphone. | Week 1,2,3,4,5,6,7,8 |
Change in time taken to complete a smartphone-based 9-Hole Peg Test conducted in-clinic. |
| Baseline, Week 4, Week 8, Week 12 |
| Total Distance (m) walked on a smartphone-based 2-minute walk test (2MWT) | Change in total distance walked on a smartphone-based at-home 2-minute walk test (2MWT). | Baseline, Week 4, Week 8, Week 12 |
| Gait velocity (m/s) on a smartphone based 2-minute walk test (2MWT) | Chance in gait velocity on a smartphone-based at-home 2-minute walk test (2MWT). | Baseline, Week 4, Week 8, Week 12 |
| Step frequency (steps/min) on a smartphone-based 2-minute walk test (2MWT) | Change in step frequency on a smartphone-based at-home 2-minute walk test (2MWT). | Baseline, Week 4, Week 8, Week 12 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D019636 | Neurodegenerative Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D000080874 | Synucleinopathies |
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