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Not yet recruiting NCT07661524

Passive Versus Active Music Therapy Parkinson's Disease

No phase Interventional Parkinson Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Passive music therapy, Active music therapy.
Who it may be relevant to
Registry conditions: Parkinson Disease (PD). Basic parameters: 50 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral Passive music therapy
    Listening to self-selected music
  • Behavioral Active music therapy
    Structured music therapy with a licensed music therapist

Primary outcome measures

  • Average time sit to stand [Time frame: Week 1, Week 2]
  • Total walking distance accumulated in 6 minutes [Time frame: Week 1, Week 2]
  • Total motivation level [Time frame: Week 1, Week 2]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

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. PMID 42058676

Identifiers

NCT: NCT07661524 · IRB-300016813 · CEDHARS Pilot Grant

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗