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

NCT05120609 | Unknown

• 1 other identifier: 1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Step Length (m)

  Baseline, Week 4, Week 8, Week 12

• Step Frequency (steps/min)

  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

• 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

• MDS-UPDRS Part II Total Score

  Baseline, Week 4, Week 8, Week 12

Other Outcomes (5)

• Average duration (seconds) of sustained vowel phonation

  Baseline, Week 4, Week 8, Week 12

• Time taken to complete a smartphone-based 9-Hole Peg Test (seconds)

  Baseline, Week 4, Week 8, Week 12

• Total Distance (m) walked on a smartphone-based 2-minute walk test (2MWT)

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

Parkinson's Application

EXPERIMENTAL

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

Digital Placebo

PLACEBO COMPARATOR

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

Device: Digital Placebo Application

Interventions

Parkinson's Application DEVICE

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.

Parkinson's Application

Digital Placebo Application DEVICE

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

Digital Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beats Medical: lead

Study Sites (1)

Meridian Clinical Research

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies

Central Study Contacts

Armistead Williams, MD

CONTACT

757-226-0655; awilliams@mcrmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 15, 2021
• Study Start: December 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)