NCT04891107

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 12, 2023

Completed
Last Updated

December 12, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

April 28, 2021

Results QC Date

August 2, 2023

Last Update Submit

November 19, 2023

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

  • 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)

    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

    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.

    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

    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)

    28 days

  • Change in Walking Endurance (m)

    28 days

  • Change in Fast Walking Gait Speed (m/s)

    28 days

  • Overall Quality of Life Impact Based on the Total Parkinson's Disease Questionnaire -39 (PDQ-39)

    28 days

  • Change in Mobility

    28 days

  • +2 more secondary outcomes

Study Arms (1)

Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System

EXPERIMENTAL
Device: Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System

Interventions

Walking Program with a Music-based, Rhythm-modulating Wearable Sensor SystemDEVICE

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.

Also known as: MedRhythms MR-005 Device
Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Boston University College of Health & Rehabilitation: Sargent College

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 37840504DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Limitations and Caveats

Sample size was small and consisted of highly educated, relatively active person with mild to moderate disease severity, potentially limiting generalizability to a less active PD population with greater disease severity. The study duration of 4 weeks was relatively short and lacked a control group.

Results Point of Contact

Title
Terry Ellis PT, PhD, FAPTA
Organization
Boston University Department of Physical Therapy & Athletic Training
tellis@bu.edu
617-353-7571

Study Officials

  • Terry Ellis, PT, Ph.D.

    College of Health & Rehabilitation Sciences: Sargent College

    PRINCIPAL INVESTIGATOR

  • Alex Pantelyat, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 18, 2021

Study Start

July 2, 2021

Primary Completion

June 8, 2022

Study Completion

June 8, 2022

Last Updated

December 12, 2023

Results First Posted

December 12, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)