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

Beats Medical1 site in 1 country40 target enrollmentDecember 2021

ConditionsParkinson Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Beats Medical
Enrollment: 40
Locations: 1
Primary Endpoint: Change in Gait Velocity (m/s)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2021

End Date

December 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Beats Medical

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Gait Velocity (m/s)

Time Frame: Baseline, Week 4, Week 8, Week 12

Gait velocity on a 10-Meter Walk Test (10MWT) conducted in-clinic.

Secondary Outcomes

Step Length (m)(Baseline, Week 4, Week 8, Week 12)
MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1(Baseline, Week 4, Week 8, Week 12)
Step Frequency (steps/min)(Baseline, Week 4, Week 8, Week 12)
MDS-UPDRS Part II Total Score(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(Baseline, Week 4, Week 8, Week 12)
Daily steps(Week 1,2,3,4,5,6,7,8)