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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|ClinicalTrials.gov Identifier: NCT05120609|
Recruitment Status : Not yet recruiting
First Posted : November 15, 2021
Last Update Posted : November 15, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Parkinson's Application Device: Digital Placebo Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
- 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).
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|Ages Eligible for Study:||30 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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,
- Access to an iPhone 7 or higher to use the Beats Medical applications.
- 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,
- Current or previous use of the Beats Medical Parkinson's application.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05120609
|Contact: Armistead Williams, MDfirstname.lastname@example.org|
|United States, Virginia|
|Meridian Clinical Research|
|Norfolk, Virginia, United States, 23502|
|Contact: Armistead Williams, MD|
|Principal Investigator: Armistead Williams, MD|
|Responsible Party:||Beats Medical|
|Other Study ID Numbers:||
|First Posted:||November 15, 2021 Key Record Dates|
|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|
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