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

Beats Medical

Status: Unknown

Conditions: Parkinson Disease

Treatments: Device: Parkinson's Application; Device: Digital Placebo Application

Study type: Interventional

Funder types: Industry

Identifiers

NCT05120609

1001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Parkinson's Application

Experimental group

Description:

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.

Treatment:

Device: Parkinson's Application

Digital Placebo

Placebo Comparator group

Description:

Subjects will have access to a digital placebo application and continue usual care.

Treatment:

Device: Digital Placebo Application