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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05120609
• Other study ID #: 1001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Beats Medical
• Contact: Armistead Williams, MD
• Phone: 757-226-0655
• Email: awilliams[@]mcrmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	Meridian Clinical Research	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Beats Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	Step Length (m)	Change in Step length on a 10-Meter Walk Test (10MWT) conducted in-clinic.	Baseline, Week 4, Week 8, Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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