Pilot Study to Evaluate the Self-Management of Gait, Speech, and Dexterity Symptoms in Parkinson's Disease Using a Smartphone Application
NCT ID: NCT05120609
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-12-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Parkinson's Application
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.
Parkinson'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.
Digital Placebo
Subjects will have access to a digital placebo application and continue usual care.
Digital Placebo Application
The application is designed to provide a method of capturing outcome measures without providing access to the therapy exercises.
Interventions
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Parkinson'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.
Digital Placebo Application
The application is designed to provide a method of capturing outcome measures without providing access to the therapy exercises.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
ALL
No
Sponsors
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Beats Medical
INDUSTRY
Responsible Party
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Locations
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Meridian Clinical Research
Norfolk, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Armistead Williams, MD
Role: primary
Other Identifiers
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1001
Identifier Type: -
Identifier Source: org_study_id