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

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Parkinson's Application

Digital Placebo Application

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Brain Diseases, Central Nervous System Diseases

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Meridian Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Parkinson's Application

Digital Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Gait Velocity (m/s)

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

Secondary Outcome Measures

Step Length (m)

Change in Step length on a 10-Meter Walk Test (10MWT) conducted in-clinic.

Step Frequency (steps/min)

Change in Step frequency on a 10-Meter Walk Test (10MWT) conducted in-clinic.

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.

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.

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.

Daily steps

Physical activity will be assessed by the relative change in daily steps recorded by the in-device sensors in the smartphone.

Full Information

NCT ID

NCT05120609

First Posted

November 4, 2021

Last Updated

November 4, 2021

Sponsor

Beats Medical

1. Study Identification

Unique Protocol Identification Number

NCT05120609

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 2021 (Anticipated)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beats Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Parkinson's Application

Arm Type

Experimental

Arm Description

Arm Title

Digital Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Parkinson's Application

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Digital Placebo Application

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Gait Velocity (m/s)

Description

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

Time Frame

Baseline, Week 4, Week 8, Week 12

Secondary Outcome Measure Information:

Title

Step Length (m)

Description

Change in Step length on a 10-Meter Walk Test (10MWT) conducted in-clinic.

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

Step Frequency (steps/min)

Description

Change in Step frequency on a 10-Meter Walk Test (10MWT) conducted in-clinic.

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1

Description

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

MDS-UPDRS Total Score for Part II Item 2.7 + Part III Item 3.4 + Part III 3.5

Description

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

MDS-UPDRS Part II Total Score

Description

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.

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

Daily steps

Description

Physical activity will be assessed by the relative change in daily steps recorded by the in-device sensors in the smartphone.

Time Frame

Week 1,2,3,4,5,6,7,8

Other Pre-specified Outcome Measures:

Title

Average duration (seconds) of sustained vowel phonation

Description

Change in the average duration of sustained vowel phonation on a smartphone-based speech assessment conducted in-clinic.

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

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

Description

Change in time taken to complete a smartphone-based 9-Hole Peg Test conducted in-clinic.

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

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

Description

Change in total distance walked on a smartphone-based at-home 2-minute walk test (2MWT).

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

Gait velocity (m/s) on a smartphone based 2-minute walk test (2MWT)

Description

Chance in gait velocity on a smartphone-based at-home 2-minute walk test (2MWT).

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

Step frequency (steps/min) on a smartphone-based 2-minute walk test (2MWT)

Description

Change in step frequency on a smartphone-based at-home 2-minute walk test (2MWT).

Time Frame

Baseline, Week 4, Week 8, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Armistead Williams, MD

Phone

757-226-0655

awilliams@mcrmed.com

Facility Information:

Facility Name

Meridian Clinical Research

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Armistead Williams, MD

First Name & Middle Initial & Last Name & Degree

Armistead Williams, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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