NCT07661524

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress1%
Aug 2026Aug 2027

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 16, 2026

Last Update Submit

June 16, 2026

Conditions

Parkinson Disease (PD)

Keywords

Music therapyExerciseMotivationParkinson'sNeurodegeneration

Outcome Measures

Primary Outcomes (3)

  • Average time sit to stand

    Time to complete 5 sit to stand test

    Week 1, Week 2

  • Total walking distance accumulated in 6 minutes

    Total distance in meters accumulated during a six minute walk test

    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

    Week 1, Week 2

Study Arms (3)

Control

NO INTERVENTION

No music therapy

Active music therapy

EXPERIMENTAL

Music therapy with a licensed music therapist

Behavioral: Active music therapy

Passive music therapy

EXPERIMENTAL

Listening to self-selected music

Behavioral: Passive music therapy

Interventions

Passive music therapyBEHAVIORAL

Listening to self-selected music

Passive music therapy
Active music therapyBEHAVIORAL

Structured music therapy with a licensed music therapist

Active music therapy

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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: 42058676BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseMotor ActivityNerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher G Ballmann, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher G Ballmann, PhD

CONTACT

205-975-0613cgb0002@uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Beginning 1 year after publication with no end date

Locations

US(1)