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

• ClinicalTrials.gov Identifier: NCT05120609
• Recruitment Status: Not yet recruiting
• First Posted: November 15, 2021
• Last Update Posted: November 15, 2021
• Sponsor: Beats Medical
• Information provided by (Responsible Party): Beats Medical

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Device: Parkinson's Application; Device: Digital Placebo Application	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Estimated Study Start Date: December 2021
• Estimated Primary Completion Date: July 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Step Length (m) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
   Change in Step length on a 10-Meter Walk Test (10MWT) conducted in-clinic.
2. Step Frequency (steps/min) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
   Change in Step frequency on a 10-Meter Walk Test (10MWT) conducted in-clinic.
3. MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1 [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

   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.

4. MDS-UPDRS Total Score for Part II Item 2.7 + Part III Item 3.4 + Part III 3.5 [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
   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.
5. MDS-UPDRS Part II Total Score [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
   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.
6. Daily steps [ Time Frame: Week 1,2,3,4,5,6,7,8 ]
   Physical activity will be assessed by the relative change in daily steps recorded by the in-device sensors in the smartphone.

Other Outcome Measures:

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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Armistead Williams, MD; 757-226-0655; awilliams@mcrmed.com

Locations

United States, Virginia

Meridian Clinical Research

Norfolk, Virginia, United States, 23502

Contact: Armistead Williams, MD

Principal Investigator: Armistead Williams, MD

Sponsors and Collaborators

Beats Medical

More Information

• Responsible Party: Beats Medical
• ClinicalTrials.gov Identifier: NCT05120609
• Other Study ID Numbers: 1001
• First Posted: November 15, 2021
• Last Update Posted: November 15, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beats Medical:

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

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases