- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07661524
Passive Versus Active Music Therapy Parkinson's Disease
June 16, 2026 updated by: Christopher Ballmann, University of Alabama at Birmingham
Effects of Active Versus Passive Music Therapy on Functional Ability and Psychophysiological Responses to Goal-Directed Exercise in People With Parkinson's Disease
The purpose of this pilot study is to identify the effects of active versus passive music therapy on functional ability and psychophysiological responses to goal-directed exercise in people with Parkinson's disease.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Using a crossover counterbalanced approach, participants with idiopathic PD (n=28) will be recruited to complete 3 separate experimental visits each with a differing condition: 1) No music (control; CON), 2) PMT, 3) AMT.
For each condition, participants will complete a battery of functional testing (sit-to-stand test; STS) and goal-based exercise (6-minute walk test; 6MWT) separated by 20-minutes of rest.
Functional ability will be determined via biomechanical parameters (i.e.
peak force, braking force, rate of force development) during the 5-time STS test.
Exercise capacity (i.e.
distance, average walking velocity) will be determined for goal-based exercise during the 6MWT.
During each test, a medical grade smartwatch will record psychophysiological (i.e.
heart rate, metabolic equivalents, electrodermal activity) responses.
Furthermore, psychometric testing for motivation, enjoyment, psychological arousal, fatigue, and rating of perceived exertion will be conducted after each test attempt.
Study Type
Interventional
Enrollment (Estimated)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christopher G Ballmann, PhD
- Phone Number: 205-975-0613
- Email: cgb0002@uab.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
Contact:
- Christopher G Ballmann, PhD
- Phone Number: 2059750613
- Email: cgb0002@uab.edu
-
Contact:
- Email: cgb0002@uab.edu
-
Principal Investigator:
- Christopher G Ballmann, PhD
-
Sub-Investigator:
- Jane Allendorfer, PhD
-
Sub-Investigator:
- Alexandra Evancho, DPT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Formal diagnosis of idiopathic PD
- Hoen & Yahr Stage <III
- Middle or old age onset of PD (at least 50 years of age)
- The ability to ambulate without assistive devices
- Stable medication regimen for four weeks prior to participation
- No changes to treatment of PD in the last month.
Exclusion Criteria:
- Primary psychiatric disease (non-PD related)
- Reports of falling in the last six weeks
- Any reason a participant or their healthcare team believed their participation in the study could negatively impact their well-being.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No music therapy
|
|
|
Experimental: Active music therapy
Music therapy with a licensed music therapist
|
Structured music therapy with a licensed music therapist
|
|
Experimental: Passive music therapy
Listening to self-selected music
|
Listening to self-selected music
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average time sit to stand
Time Frame: Week 1, Week 2
|
Time to complete 5 sit to stand test
|
Week 1, Week 2
|
|
Total walking distance accumulated in 6 minutes
Time Frame: Week 1, Week 2
|
Total distance in meters accumulated during a six minute walk test
|
Week 1, Week 2
|
|
Total motivation level
Time Frame: Week 1, Week 2
|
Motivation levels as assessed by a visual analog scale on 0 to 100 where 0 equals the absence of motivation and 100 indicates extremely motivated
|
Week 1, Week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christopher G Ballmann, PhD, University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Study Registration Dates
First Submitted
June 16, 2026
First Submitted That Met QC Criteria
June 16, 2026
First Posted (Actual)
June 22, 2026
Study Record Updates
Last Update Posted (Actual)
June 22, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pathologic Processes
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Pathological Conditions, Signs and Symptoms
- Behavior
- Parkinson Disease
- Nerve Degeneration
- Motor Activity
Other Study ID Numbers
- IRB-300016813
- CEDHARS Pilot Grant (Other Grant/Funding Number: UAB Center for Engagement in Disability Health and Rehabilitation Sciences)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
Beginning 1 year after publication with no end date
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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