Parkinson DiseaseNCT04891107
Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease
A study testing Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System in people with Parkinson Disease, run by MedRhythms, Inc. at 2 sites in United States.
Trial summary
The purpose of this clinical study is to evaluate the effects of music, tailored to the participant's cadence, on adherence, quality of life, gait speed, functional mobility, and walking activity in individuals with Parkinson disease when used in the home and community environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2021to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic, typical Parkinson disease.
- Modified Hoehn and Yahr stages 1-3 per physical exam.
- Able to walk independently without physical assistance or an assistive device.
Who cannot join
- Diagnosis of atypical Parkinsonism.
- Moderately or significantly disturbing freezing episodes during daily walking.
- Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA).
- Significant hearing impairment.
- Currently participating in physical therapy.
- Cardiac problems that interfere with the ability to safely exercise.
- Orthopedic problems in the lower extremities or spine that may limit walking distance.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Boston University College of Health & Rehabilitation: Sargent College
Boston, Massachusetts, 02215
About this study
Official title: Feasibility and Preliminary Effects of Using a Music-based, Rhythm-modulating Wearable Sensor System in the Community in Persons With Parkinson Disease
The purpose of this clinical study is to evaluate the effects of music, tailored to the participant's cadence, on adherence, quality of life, gait speed, functional mobility, and walking activity in individuals with Parkinson disease when used in the home and community environment.
Read the detailed description
Persons with Parkinson disease will be enrolled to determine the effects of a community walking program with a music-based device on adherence, quality of life, walking speed and walking activity. The walking program will be carried out independently by participants in their home/community environment. Noninvasive functional assessments commonly administered in clinical practice will be used to measure the variables of interest.
- Conditions
- Parkinson Disease
- Being tested
- Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking Program with a Music-based, Rhythm-modulating Wearable Sensor SystemDevice
Also called MedRhythms MR-005 Device
Participants will walk using the music-based, rhythm-modulating wearable sensor system (foot sensors, mobile device with mobile app and headphones) for thirty (30) minutes at a time, 5 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System | Experimental | Not described Receives: Device: Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Adherence (Feasibility) to Walking Program Schedule Based on Percentage of Scheduled Sessions Completed
Percentage of scheduled sessions completed (5 times per week for 4 weeks)
Measured: 28 days
Safety (Feasibility) Based on the Number of Adverse Events During Training
Safety as assessed by number of adverse events during training with the music-based device
Measured: 28 days
Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire.
Usability as assessed by participant ratings on Acceptability and Usability Questionnaire. The Questionnaire is comprised of adapted items from the System Usability Scale, Post Study System Usability Questionnaire, Technology Assessment Model Measurement Scales, and Usefulness, Satisfaction, and Ease questionnaire as described in Ben-Zeev D, et al., 2014. Participants were asked to rate their agreement with a series of statements about the intervention (26-items) using three Likert Scale responses (disagree, neutral, or agree) for each item. The number of responses in each category of disagree, neutral, or agree were summed and averaged across the total number of participants who responded to report an overall percentage within each category of disagree, neutral, or agree on the acceptability and usability of the device. A higher overall percentage of 'agree' responses indicate a higher degree of usability as rated by participants.
Measured: 28 days
Change in Mobility Impact Based on the Mobility Dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39) Between Baseline to Last Visit
Mobility impact as assessed by Parkinson's Disease Questionnaire-39 (PDQ-39) mobility dimension (questions #1-10 from the total PDQ-39 questionnaire). Each question is scored on a 0-4 ordinal scoring system then summed to generate the sub-scale score of the mobility dimension. Lower scores represent better quality of life.
Mobility Dimension Subscale Range: 0-100
Measured: 28 days
Secondary outcomes (7)
Change in Disease Severity Based on the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)
Change in disease severity at baseline as compared to end of study participation (or earlier if study participant withdraws) as determined by the MDS-UPDRS III. Scores range between 0-132 with lower scores represent less disease severity.
Measured: 28 days
Change in Walking Endurance (m)
Change in walking endurance (m) at baseline as compared to end of study participation (or earlier if study participant withdraws) as determined by the 6 Minute Walk Test (6MWT)
Measured: 28 days
Change in Fast Walking Gait Speed (m/s)
Change in fast walking gait speed (m/s) at baseline as compared to end of study participation (or earlier if study participant withdraws) as determined by the 10 Meter Walk Test (10MWT)
Measured: 28 days
Overall Quality of Life Impact Based on the Total Parkinson's Disease Questionnaire -39 (PDQ-39)
Overall quality of life impact at baseline as compared to end of study participation (or earlier if study participant withdraws) as assessed by Parkinson's Disease Questionnaire-39 (PDQ-39). The PDQ-39 contains 8 dimensions of function and well-being which are summed to generate the total PDQ-39 score (ranging from 0-100) where lower scores represent better quality of life.
Measured: 28 days
Change in Mobility
Change in mobility as measured by the Five Times Sit to Stand Test
Measured: 28 days
Change in Amount of Walking (Steps/Day)
Change in amount (steps/day) of walking activity (proof-of-concept) at baseline as compared to during training as measured by the StepWatch Activity Monitor (SAM)
Measured: 8 days
Change in Intensity (Moderate Intensity Minutes; >100 Steps/Min)
Change in intensity (moderate intensity minutes; >100 steps/min) of walking activity (proof-of-concept) at baseline as compared to during training as measured by the StepWatch Activity Monitor (SAM)
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start2 Jul 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedRhythms, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, Boston University
- Responsible party
- Sponsor
- Investigators
- Terry Ellis, PT, Ph.D., Principal investigator, College of Health & Rehabilitation Sciences: Sargent CollegeAlex Pantelyat, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891107
- Sponsor's protocol ID
- CM082000501
- Status last verified
- Nov 2023
- First submitted
- 28 Apr 2021
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zajac JA, Porciuncula F, Cavanaugh JT, McGregor C, Harris BA, Smayda KE, Awad LN, Pantelyat A, Ellis TD. Feasibility and Proof-of-Concept of Delivering an Autonomous Music-Based Digital Walking Intervention to Persons with Parkinson's Disease in a Naturalistic Setting. J Parkinsons Dis. 2023;13(7):1253-1265. doi: 10.3233/JPD-230169.
PubMed 37840504
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effects of Using a Music-based, Rhythm-modulating Wearable Sensor System in the Community in Persons With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04891107
- Acronym / sponsor ID
- CM082000501
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- MedRhythms, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, Boston University
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Posted 12 Dec 2023
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 clinical study is to evaluate the effects of music, tailored to the participant's cadence, on adherence, quality of life, gait speed, functional mobility, and walking activity in individuals with Parkinson disease when used in the home and community environment.
Detailed description
Persons with Parkinson disease will be enrolled to determine the effects of a community walking program with a music-based device on adherence, quality of life, walking speed and walking activity. The walking program will be carried out independently by participants in their home/community environment. Noninvasive functional assessments commonly administered in clinical practice will be used to measure the variables of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System | Experimental | Device: Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic, typical Parkinson disease.
- Modified Hoehn and Yahr stages 1-3 per physical exam.
- Able to walk independently without physical assistance or an assistive device.
Key exclusion criteria (7 listed)
- Diagnosis of atypical Parkinsonism.
- Moderately or significantly disturbing freezing episodes during daily walking.
- Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA).
- Significant hearing impairment.
- Currently participating in physical therapy.
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 |
|---|---|---|
| Walking Program with a Music-based, Rhythm-modulating Wearable Sensor SystemAlso: MedRhythms MR-005 DeviceParticipants will walk using the music-based, rhythm-modulating wearable sensor system (foot sensors, mobile device with mobile app and headphones) for thirty (30) minutes at a time, 5 times a week for 4 weeks. | Device | Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System |
Primary outcome
Observed Adherence (Feasibility) to Walking Program Schedule Based on Percentage of Scheduled Sessions Completed
Time frame: 28 days
Percentage of scheduled sessions completed (5 times per week for 4 weeks)
Safety (Feasibility) Based on the Number of Adverse Events During Training
Time frame: 28 days
Safety as assessed by number of adverse events during training with the music-based device
Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire.
Time frame: 28 days
Usability as assessed by participant ratings on Acceptability and Usability Questionnaire. The Questionnaire is comprised of adapted items from the System Usability Scale, Post Study System Usability Questionnaire, Technology Assessment Model Measurement Scales, and Usefulness, Satisfaction, and Ease questionnaire as described in Ben-Zeev D, et al., 2014. Participants were asked to rate their agreement with a series of statements about the intervention (26-items) using three Likert Scale responses (disagree, neutral, or agree) for each item. The number of responses in each category of disagree, neutral, or agree were summed and averaged across the total number of participants who responded to report an overall percentage within each category of disagree, neutral, or agree on the acceptability and usability of the device. A higher overall percentage of 'agree' responses indicate a higher degree of usability as rated by participants.
Change in Mobility Impact Based on the Mobility Dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39) Between Baseline to Last Visit
Time frame: 28 days
Mobility impact as assessed by Parkinson's Disease Questionnaire-39 (PDQ-39) mobility dimension (questions #1-10 from the total PDQ-39 questionnaire). Each question is scored on a 0-4 ordinal scoring system then summed to generate the sub-scale score of the mobility dimension. Lower scores represent better quality of life. Mobility Dimension Subscale Range: 0-100
7 secondary outcomes
Change in Disease Severity Based on the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)
Time frame: 28 days
Change in Walking Endurance (m)
Time frame: 28 days
Change in Fast Walking Gait Speed (m/s)
Time frame: 28 days
Overall Quality of Life Impact Based on the Total Parkinson's Disease Questionnaire -39 (PDQ-39)
Time frame: 28 days
Change in Mobility
Time frame: 28 days
Change in Amount of Walking (Steps/Day)
Time frame: 8 days
Change in Intensity (Moderate Intensity Minutes; >100 Steps/Min)
Time frame: 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37840504Zajac JA, Porciuncula F, Cavanaugh JT, McGregor C, Harris BA, Smayda KE, Awad LN, Pantelyat A, Ellis TD. Feasibility and Proof-of-Concept of Delivering an Autonomous Music-Based Digital Walking Intervention to Persons with Parkinson's Disease in a Naturalistic Setting. J Parkinsons Dis. 2023;13(7):1253-1265. doi: 10.3233/JPD-230169.
- 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.
Terry Ellis, PT, Ph.D. principal investigator
College of Health & Rehabilitation Sciences: Sargent College
Alex Pantelyat, M.D. principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System in people with Parkinson Disease, run by MedRhythms, Inc. at 2 sites 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Yes. Results are posted in the registry (first posted 12 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed Adherence (Feasibility) to Walking Program Schedule Based on Percentage of Scheduled Sessions Completed (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891107, which also lists 1 linked publication.
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 12 Dec 2023.