Sing for Your Saunter Part 2 R33

Phase 2

Recruiting

• Conditions: Parkinson Disease
• Interventions: Behavioral: Self Cueing Training; Behavioral: External Cueing Training

• Registration Number: NCT06115382
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-18
• Study Start: 2023-10-05
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self cueing	Self Cueing Training	Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.
External cueing	External Cueing Training	External cueing using music, one hour sessions twice weekly for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Gait speed	Baseline and 12 weeks	How quickly someone walks
MRI Bold Beta Weights	Baseline and 12 weeks	Measure of blood oxygen levels in different brain regions indicative of level of activity within different brain regions

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States