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Completed

NCT Number: NCT06115382

Sing For Your Saunter Part 2 R33

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

  • 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

Treatment and study plan

Self Cueing Training

Behavioral

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

Behavioral

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 outcomes

  1. Gait Speed

    Time frame: Baseline and 12 weeks

    How quickly someone walks

  2. MRI Bold Beta Weights

    Time frame: Baseline and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: SFYS2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2023
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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