Parkinson Disease (PD)NCT07661524
Passive Versus Active Music Therapy Parkinson's Disease
A study testing Passive music therapy and Active music therapy in people with Parkinson Disease (PD), run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Passive music therapy and Active music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Christopher G Ballmann, PhD, 2059750613, cgb0002@uab.edu
cgb0002@uab.edu
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Passive music therapy, Active music therapy
- Keywords
- Music therapy, Exercise, Motivation, Parkinson's, Neurodegeneration
- Medical subject headings
- Parkinson Disease, Motor Activity, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive music therapyBehavioural
Listening to self-selected music
Active music therapyBehavioural
Structured music therapy with a licensed music therapist
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No music therapy |
| Active music therapy | Experimental | Music therapy with a licensed music therapist Receives: Behavioral: Active music therapy |
| Passive music therapy | Experimental | Listening to self-selected music Receives: Behavioral: Passive music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time sit to stand
Time to complete 5 sit to stand test
Measured: Week 1, Week 2
Total walking distance accumulated in 6 minutes
Total distance in meters accumulated during a six minute walk test
Measured: Week 1, Week 2
Total motivation level
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
Measured: Week 1, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Rooted Music Therapy
- Responsible party
- Principal investigator, Christopher Ballmann, University of Alabama at Birmingham
- Investigators
- Christopher G Ballmann, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661524
- Sponsor's protocol ID
- IRB-300016813
- Other IDs
- CEDHARS Pilot Grant
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Porrill SL, Allendorfer JB, Evancho AM, Ferguson CC, LaChenaye JM, Nguyen HM, Rogers RR, Ballmann CG. Effects of self-selected music on psychophysiological responses to goal-directed exercise in Parkinson's disease. Front Rehabil Sci. 2026 Apr 14;7:1778451. doi: 10.3389/fresc.2026.1778451. eCollection 2026.
PubMed 42058676
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Versus Passive Music Therapy on Functional Ability and Psychophysiological Responses to Goal-Directed Exercise in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07661524
- Acronym / sponsor ID
- IRB-300016813
- Conditions
- Parkinson Disease (PD)
- Keywords
- Music therapy, Exercise, Motivation, Parkinson's, Neurodegeneration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Rooted Music Therapy
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Jun 2026 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No music therapy |
| Active music therapy | Experimental | Behavioral: Active music therapyMusic therapy with a licensed music therapist |
| Passive music therapy | Experimental | Behavioral: Passive music therapyListening to self-selected music |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Passive music therapyListening to self-selected music | Behavioural | Passive music therapy |
| Active music therapyStructured music therapy with a licensed music therapist | Behavioural | Active music therapy |
Primary outcome
Average time sit to stand
Time frame: Week 1, Week 2
Time to complete 5 sit to stand test
Total walking distance accumulated in 6 minutes
Time frame: Week 1, Week 2
Total distance in meters accumulated during a six minute walk test
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 42058676Porrill SL, Allendorfer JB, Evancho AM, Ferguson CC, LaChenaye JM, Nguyen HM, Rogers RR, Ballmann CG. Effects of self-selected music on psychophysiological responses to goal-directed exercise in Parkinson's disease. Front Rehabil Sci. 2026 Apr 14;7:1778451. doi: 10.3389/fresc.2026.1778451. eCollection 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Christopher G Ballmann, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive music therapy and Active music therapy in people with Parkinson Disease (PD), run by University of Alabama at Birmingham 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher G Ballmann, PhD (205-975-0613, cgb0002@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average time sit to stand (time frame: Week 1, Week 2). The study lists 3 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 NCT07661524, 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 8 Oct 2026.