Sing For Your Saunter Part 2 R33 (SFYS2)

Sing for Your Saunter: Using Self-Generated Rhythmic Cues to Enhance Gait in Parkinson's

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Self Cueing Training; Behavioral: External Cueing Training

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self cueing; Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.	Behavioral: 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.
Experimental: External cueing; External cueing using music, one hour sessions twice weekly for 12 weeks.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Speed	How quickly someone walks	Baseline and 12 weeks
MRI Bold Beta Weights	Measure of blood oxygen levels in different brain regions indicative of level of activity within different brain regions. We analyzed the Blood Oxygen Level Dependent (BOLD) signal in the brain to determine where there were areas of significant changes in brain activity, relative to rest, when participants were moving with to the beat during self cueing (mental singing) and move to the beat during external cueing (music). BOLD values are reported are Beta weights. Positive values indicate an increase in activity relative to rest and negative values indicate a decrease in activity relative to rest.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Actual): October 14, 2025
• Study Completion (Actual): December 21, 2025

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 202309088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data for individual participants available by request. Only de-identified data will be shared and only for individuals who consent to have their data shared with people who are not part of the original research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No