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

N/AUnknownNCT05120609

Beats Medical40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Parkinson's ApplicationDEVICE

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 ApplicationDEVICE

The application is designed to provide a method of capturing outcome measures without providing access to the therapy exercises.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (1)

Meridian Clinical Research

Norfolk, Virginia, United States