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Not recruiting
Phase 2

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT06115382

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Self Cueing Training

External Cueing Training

Study Details

Brief summary:

The goal of this clinical trial is to compare to rhythm-based walking interventions to enhance gait in people with Parkinson's disease. The main questions it aims to answer are:

  • How does rhythm-based training influence walking performance?
  • How does brain activity change following rhythm-based training? Participants will perform walking to music and walking while singing, and will train on the use of these rhythms for 12 weeks. The investigators will compare the effects of training with music to training with singing.

Conditions

Parkinson Disease

Study ID

NCT06115382

Start date

Oct 5, 2023

Status verified date

Feb, 2025

Completion date

Nov 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. at least 30 years of age
2. diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria
3. Hoehn \& Yahr stages 2-3 (mild to moderate disease severity)
4. evidence of walking impairment (score at least 1 on gait item of MDS_UPDRS)

4) stable on all Parkinson disease medications for at least 2 months prior to study entry 5) willing and able to provide informed consent 6) right-handed

Exclusion Criteria:

1. diagnosis of any other neurological condition
2. a score of 2 or greater on item # 3 on the freezing of gait questionnaire
3. significant cognitive impairment
4. unstable medical or concomitant illnesses or psychiatric conditions which, in the opinion of the investigators, would preclude successful participation
5. cardiac problems that interfere with ability to safely participate
6. orthopedic problems in the lower extremities or spine that may limit walking
7. contraindications for magnetic resonance imaging
8. unable to walk for 10 continuous minutes independently
9. left-handed
10. uncontrolled tremor or dyskinesia

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self cueing

Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.

experimental: External cueing

External cueing using music, one hour sessions twice weekly for 12 weeks.

Interventions

Self Cueing Training

Group classes led by a music therapist and using singing as a self-generated cue, with a focus on rhythm perception, rhythm generation and synchronization of movement to rhythms.

External Cueing Training

Group classes led by a music therapist and using music as an external cue, with a focus on rhythm perception, rhythm generation and synchronization of movement to rhythms.

Primary outcome measure

  • Gait speed [ Time Frame: Baseline and 12 weeks ]
  • MRI Bold Beta Weights [ Time Frame: Baseline and 12 weeks ]

Central Contacts and Locations

Central contacts

Gammon Earhart, PhD, PT

3142861407earhartg@wustl.edu

Martha Hessler

3142841478hesslerm@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St. Louis, Missouri, United States, 63108

Contacts

Gammon M Earhart, PhD,PT

314-286-1425earhartg@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Feb 17, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-02-17.