Sing For Your Saunter Part 2 R33

Parkinson Disease Clinical Trial

— SFYS2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115382
• Other study ID #: 202309088
• Status: Recruiting
• Phase: Phase 2
• Start date: October 5, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: Gammon Earhart, PhD, PT
• Phone: 3142861407
• Email: earhartg[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: November 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed	How quickly someone walks	Baseline and 12 weeks
Primary	MRI Bold Beta Weights	Measure of blood oxygen levels in different brain regions indicative of level of activity within different brain regions	Baseline and 12 weeks