Parkinson DiseasePhase 2SFYS2NCT06115382

Sing For Your Saunter Part 2 R33

A Phase 2 study testing Self Cueing Training and External Cueing Training in people with Parkinson Disease, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Self Cueing Training and External Cueing Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 5 Oct 2023to 21 Dec 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)
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

Who cannot join

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

Show all 10Show fewer

contraindications for magnetic resonance imaging
unable to walk for 10 continuous minutes independently
left-handed
uncontrolled tremor or dyskinesia

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: 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.

Conditions: Parkinson Disease
Being tested: Self Cueing Training, External Cueing Training
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self Cueing TrainingBehavioural
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 TrainingBehavioural
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.

Study groups in NCT06115382
Study group	Role	What they receive
Self cueing	Experimental	Self-cueing training using singing, one hour sessions twice weekly for 12 weeks. Receives: Behavioral: Self Cueing Training
External cueing	Experimental	External cueing using music, one hour sessions twice weekly for 12 weeks. Receives: Behavioral: External Cueing Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Gait Speed
How quickly someone walks
Measured: 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.
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202321 Dec 2025

First posted3 Nov 2023
Study start5 Oct 2023
Primary completion14 Oct 2025
Study completion21 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06115382
Sponsor's protocol ID: 202309088
Acronym: SFYS2
Status last verified: Mar 2026
First submitted: 18 Sep 2023
Last updated: 2 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sing for Your Saunter: Using Self-Generated Rhythmic Cues to Enhance Gait in Parkinson's
ClinicalTrials.gov ID: NCT06115382
Acronym / sponsor ID: SFYS2 / 202309088
Conditions: Parkinson Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 5 Oct 2023 (actual)
Primary completion: 14 Oct 2025 (actual)
Study completion: 21 Dec 2025 (actual)
First posted: 3 Nov 2023 (actual)
Results: Posted 2 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Self cueing	Experimental	Behavioral: Self Cueing TrainingSelf-cueing training using singing, one hour sessions twice weekly for 12 weeks.
External cueing	Experimental	Behavioral: External Cueing TrainingExternal cueing using music, one hour sessions twice weekly for 12 weeks.

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)
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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Self Cueing TrainingGroup 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.	Behavioural	Self cueing
External Cueing TrainingGroup 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.	Behavioural	External cueing

Primary outcome

Gait Speed
Time frame: Baseline and 12 weeks
How quickly someone walks
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.

Results and safety

Results posted to the registry on 2 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Self Cueing	38	28
External Cueing	36	33

Primary outcome: Gait Speed

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: meters per second

Measure	Self Cueing n = 28	External Cueing n = 33
Baseline gait speed	1.09 (0.20)	1.04 (0.23)
Gait speed at 12 weeks	1.15 (0.21)	1.08 (0.22)

Primary outcome: MRI Bold Beta Weights

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: Beta weights (arbitrary units)

Measure	Self Cueing n = 19	External Cueing n = 24
Baseline bilateral auditory cortex activity when tapping during mental singing	-.892 (.323)	-.764 (.323)
12 weeks bilateral auditory cortex activity when tapping during mental singing	-.854 (.277)	-.674 (.378)
Baseline left putamen activity when tapping during mental singing	-.018 (.197)	-.023 (.210)
12 weeks left putamen activity when tapping to mental singing	.060 (.186)	-.093 (.156)
Baseline bilateral anterior cerebellum activity when tapping during mental singing	-.023 (.293)	.014 (.220)
12 weeks bilateral anterior cerebellum activity when tapping during mental singing	.044 (.275)	-.035 (.199)
Baseline bilateral auditory cortex activity when tapping to music	.492 (.286)	.249 (.500)
12 week bilateral auditory cortex activity when tapping to music	.324 (.236)	.339 (.309)

Population analysed: Results are presented for each group during finger tapping during mental singing and finger tapping when listening to music at baseline and after 12 weeks of training in either the self cueing intervention or the external cueing interevention.

Adverse events

Time frame: From enrollment to end of follow-up, up to 20 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Self Cueing	0 of 38 (0%)	15 of 38 (39.5%)	0 of 38
External Cueing	0 of 36 (0%)	7 of 36 (19.4%)	0 of 36

Limitations and caveats (from the sponsor): Nothing to report

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. 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.

Related trials for Parkinson Disease

RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Enrolling by invitation
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
Parkinson's Disease, Depression
RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Self Cueing Training and External Cueing Training in people with Parkinson Disease, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Speed (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06115382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.