SFYS2: Sing For Your Saunter Part 2 R33

Sponsor

Washington University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT06115382

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Locations

Arms

25.9

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Behavioral: Self Cueing Training Behavioral: External Cueing Training	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 5, 2023

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63108
2	Washington University School of Medicine	Saint Louis	Missouri	United States	63108

Sponsors and Collaborators

Washington University School of Medicine
National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gammon M Earhart, Professor, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT06115382

Other Study ID Numbers:

202309088

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Nov 3, 2023