Parkinson DiseaseNCT05120609
Pilot Study to Evaluate the Self-Management of Gait, Speech, and Dexterity Symptoms in Parkinson's Disease Using a Smartphone Application
A study testing Parkinson's Application in people with Parkinson Disease, run by Beats Medical at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Parkinson's Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- History of falls in the past 6 months,
- Pregnancy,
- Current or previous use of the Beats Medical Parkinson's application.
Trial locations and contacts
1 site in 1 country.
United States1 site
Meridian Clinical Research
Norfolk, Virginia, 23502
Armistead Williams, MD
Armistead Williams, MD
About this study
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
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.
- Conditions
- Parkinson Disease
- Being tested
- Parkinson's Application, Digital Placebo Application
- Keywords
- Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Brain Diseases, Central Nervous System Diseases
- Medical subject headings
- Parkinson Disease, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parkinson's ApplicationDevice
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 ApplicationDevice
The application is designed to provide a method of capturing outcome measures without providing access to the therapy exercises.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Application | Experimental | 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. Receives: Device: Parkinson's Application |
| Digital Placebo | Placebo comparator | Subjects will have access to a digital placebo application and continue usual care. Receives: Device: Digital Placebo Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Velocity (m/s)
Gait velocity on a 10-Meter Walk Test (10MWT) conducted in-clinic.
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (6)
Step Length (m)
Change in Step length on a 10-Meter Walk Test (10MWT) conducted in-clinic.
Measured: Baseline, Week 4, Week 8, Week 12
Step Frequency (steps/min)
Change in Step frequency on a 10-Meter Walk Test (10MWT) conducted in-clinic.
Measured: Baseline, Week 4, Week 8, Week 12
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.
Measured: Baseline, Week 4, Week 8, Week 12
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.
Measured: Baseline, Week 4, Week 8, Week 12
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.
Measured: Baseline, Week 4, Week 8, Week 12
Daily steps
Physical activity will be assessed by the relative change in daily steps recorded by the in-device sensors in the smartphone.
Measured: Week 1,2,3,4,5,6,7,8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beats Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120609
- Sponsor's protocol ID
- 1001
- Status last verified
- Oct 2021
- First submitted
- 4 Nov 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05120609
- Acronym / sponsor ID
- 1001
- Conditions
- Parkinson Disease
- Keywords
- Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Brain Diseases, Central Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beats MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Application | Experimental | Device: Parkinson's ApplicationSubjects 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. |
| Digital Placebo | Placebo comparator | Device: Digital Placebo ApplicationSubjects will have access to a digital placebo application and continue usual care. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parkinson's ApplicationThe 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. | Device | Parkinson's Application |
| Digital Placebo ApplicationThe application is designed to provide a method of capturing outcome measures without providing access to the therapy exercises. | Device | Digital Placebo |
Primary outcome
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.
6 secondary outcomes
Step Length (m)
Time frame: Baseline, Week 4, Week 8, Week 12
Step Frequency (steps/min)
Time frame: Baseline, Week 4, Week 8, Week 12
MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1
Time frame: Baseline, Week 4, Week 8, Week 12
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
MDS-UPDRS Part II Total Score
Time frame: Baseline, Week 4, Week 8, Week 12
Daily steps
Time frame: Week 1,2,3,4,5,6,7,8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parkinson's Application in people with Parkinson Disease, run by Beats Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Armistead Williams, MD (757-226-0655, awilliams@mcrmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Velocity (m/s) (time frame: Baseline, Week 4, Week 8, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.