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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Parkinson's Application; Device: Digital Placebo Application

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armistead Williams, MD; Phone Number: 757-226-0655; Email: awilliams@mcrmed.com

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Meridian Clinical Research
      • Contact: Armistead Williams, MD
      • Principal Investigator: Armistead Williams, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Placebo Comparator: Digital Placebo; Subjects will have access to a digital placebo application and continue usual care.	Device: Digital Placebo Application; The application is designed to provide a method of capturing outcome measures without providing access to the therapy exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Length (m)	Change in Step length on a 10-Meter Walk Test (10MWT) conducted in-clinic.	Baseline, Week 4, Week 8, Week 12
Step Frequency (steps/min)	Change in Step frequency on a 10-Meter Walk Test (10MWT) conducted in-clinic.	Baseline, Week 4, Week 8, Week 12
MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1	Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is designed to monitor the burden and extent of Parkinson's disease. The MDS-UPDRS is divided into 4 parts: (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. In each part, all items are rated on a scale from 0-4, with higher scores reflecting greater severity. The sum of items 2.1 (Speech) and Part III 3.1 (Speech) will be used to calculate a total score to assess speech abilities.	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	The sum of items 2.7 (handwriting), 3.4 (finger tapping), and 3.5 (hand movements) will be used to calculate a total score to assess manual dexterity. All items are rated on a scale from 0-4, with higher scores reflecting greater severity.	Baseline, Week 4, Week 8, Week 12
MDS-UPDRS Part II Total Score	For MDS-UPDRS Part II (motor experiences of daily living) scores, the scale range for Part II Total Score is 0-52, with higher scores reflecting greater severity.	Baseline, Week 4, Week 8, Week 12
Daily steps	Physical activity will be assessed by the relative change in daily steps recorded by the in-device sensors in the smartphone.	Week 1,2,3,4,5,6,7,8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average duration (seconds) of sustained vowel phonation	Change in the average duration of sustained vowel phonation on a smartphone-based speech assessment conducted in-clinic.	Baseline, Week 4, Week 8, Week 12
Time taken to complete a smartphone-based 9-Hole Peg Test (seconds)	Change in time taken to complete a smartphone-based 9-Hole Peg Test conducted in-clinic.	Baseline, Week 4, Week 8, Week 12
Total Distance (m) walked on a smartphone-based 2-minute walk test (2MWT)	Change in total distance walked on a smartphone-based at-home 2-minute walk test (2MWT).	Baseline, Week 4, Week 8, Week 12
Gait velocity (m/s) on a smartphone based 2-minute walk test (2MWT)	Chance in gait velocity on a smartphone-based at-home 2-minute walk test (2MWT).	Baseline, Week 4, Week 8, Week 12
Step frequency (steps/min) on a smartphone-based 2-minute walk test (2MWT)	Change in step frequency on a smartphone-based at-home 2-minute walk test (2MWT).	Baseline, Week 4, Week 8, Week 12

Collaborators and Investigators

• Sponsor: Beats Medical

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Movement Disorders; Central Nervous System Diseases; Neurodegenerative Diseases; Brain Diseases
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No