Pilot Study to Evaluate the Self-Management of Gait, Speech, and Dexterity Symptoms in Parkinson's Disease Using a Smartphone Application

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Cross-Over, Placebo-Controlled Pilot Study to Evaluate the Self-Management of Gait, Speech and Dexterity in Patients With Parkinson's Disease Using a Novel Digital Therapeutic Approach

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Parkinson's Application
* Device: Digital Placebo Application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson's Application<br>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. | Device: Parkinson's Application<br>* 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.<br>|
| Placebo Comparator: Digital Placebo<br>Subjects will have access to a digital placebo application and continue usual care. | Device: Digital Placebo Application<br>* The application is designed to provide a method of capturing outcome measures without providing access to the therapy exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Brain Diseases, Central Nervous System Diseases