Parkinson Disease
Conditions
Keywords
Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Brain Diseases, Central Nervous System Diseases
Brief summary
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.
Interventions
DEVICEParkinson's Application
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.
DEVICEDigital Placebo Application
The application is designed to provide a method of capturing outcome measures without providing access to the therapy exercises.
Sponsors
Beats Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female subjects at least 30 years of age or older, * History of idiopathic Parkinson's Disease (Hoehn and Yahr stage of II-IV), * Normal joint range of motion in both legs, * Able to walk independently for 10 feet with or without an assistive device, * Parkinson's gait and mild to moderate speech impairment, * No history of vestibular disease, * No evidence of dementia (MMSE ≥24), * Clear benefit from Levodopa, * Agrees to Beats Medical Application Privacy Policy and Terms of Use, * Access to an iPhone 7 or higher to use the Beats Medical applications.
Exclusion criteria
* Medical condition for which exercise is contraindicated, * History or evidence of neurological deficit other than Parkinson's Disease that could interfere, such as previous stroke or muscle disease, * History or evidence of orthopaedic or muscular problems, * Subject is currently enrolled in a study to evaluate an investigational drug or device, * Subject unable or unwilling to provide informed consent, * Vulnerable populations as deemed inappropriate for the study by site Principal Investigator, * History of falls in the past 6 months, * Pregnancy, * Current or previous use of the Beats Medical Parkinson's application.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Velocity (m/s) | Baseline, Week 4, Week 8, Week 12 | Gait velocity on a 10-Meter Walk Test (10MWT) conducted in-clinic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Step Frequency (steps/min) | Baseline, Week 4, Week 8, Week 12 | Change in Step frequency on a 10-Meter Walk Test (10MWT) conducted in-clinic. |
| Step Length (m) | Baseline, Week 4, Week 8, Week 12 | Change in Step length on a 10-Meter Walk Test (10MWT) conducted in-clinic. |
| MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1 | Baseline, Week 4, Week 8, Week 12 | 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. |
| MDS-UPDRS Total Score for Part II Item 2.7 + Part III Item 3.4 + Part III 3.5 | Baseline, Week 4, Week 8, Week 12 | 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. |
| MDS-UPDRS Part II Total Score | Baseline, Week 4, Week 8, Week 12 | 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. |
| Daily steps | Week 1,2,3,4,5,6,7,8 | Physical activity will be assessed by the relative change in daily steps recorded by the in-device sensors in the smartphone. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Distance (m) walked on a smartphone-based 2-minute walk test (2MWT) | Baseline, Week 4, Week 8, Week 12 | Change in total distance walked on a smartphone-based at-home 2-minute walk test (2MWT). |
| Gait velocity (m/s) on a smartphone based 2-minute walk test (2MWT) | Baseline, Week 4, Week 8, Week 12 | Chance in gait velocity on a smartphone-based at-home 2-minute walk test (2MWT). |
| Step frequency (steps/min) on a smartphone-based 2-minute walk test (2MWT) | Baseline, Week 4, Week 8, Week 12 | Change in step frequency on a smartphone-based at-home 2-minute walk test (2MWT). |
| Time taken to complete a smartphone-based 9-Hole Peg Test (seconds) | Baseline, Week 4, Week 8, Week 12 | Change in time taken to complete a smartphone-based 9-Hole Peg Test conducted in-clinic. |
| Average duration (seconds) of sustained vowel phonation | Baseline, Week 4, Week 8, Week 12 | Change in the average duration of sustained vowel phonation on a smartphone-based speech assessment conducted in-clinic. |
Countries
United States
Contacts
Primary ContactArmistead Williams, MD
Outcome results
None listed