Clinical trial NCT05120609: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Lead sponsor: Beats Medical
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Gait Velocity (m/s)
timeFrame: Baseline, Week 4, Week 8, Week 12
Secondary outcomes:
measure: Step Length (m)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Step Frequency (steps/min)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: MDS-UPDRS Total Score for Part II Item 2.7 + Part III Item 3.4 + Part III 3.5
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: MDS-UPDRS Part II Total Score
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Daily steps
timeFrame: Week 1,2,3,4,5,6,7,8
Other outcomes:
measure: Average duration (seconds) of sustained vowel phonation
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Time taken to complete a smartphone-based 9-Hole Peg Test (seconds)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Total Distance (m) walked on a smartphone-based 2-minute walk test (2MWT)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Gait velocity (m/s) on a smartphone based 2-minute walk test (2MWT)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Step frequency (steps/min) on a smartphone-based 2-minute walk test (2MWT)
timeFrame: Baseline, Week 4, Week 8, Week 12
Locations:
city: Norfolk
country: United States
facility: Meridian Clinical Research
state: Virginia
Study officials:
References: