Parkinson DiseaseSFYSNCT04246476
Sing for Your Saunter
A study testing Mentally singing and Listening to music in people with Parkinson Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Older adults, and particularly those with Parkinson disease (PD), may experience walking difficulties that negatively impact their daily function and quality of life. This project will examine the impact of music and mentally singing on walking performance, with a goal of understanding what types of rhythmic cues are… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Mentally singing and Listening to music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 20 Jan 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 30 years of age;
- willing and able to provide informed consent;
- right-handed or ambidextrous;
- normal hearing;
- weight less than 250 lbs; and
- able to walk for 10 continuous minutes independently.
Show all 11Show fewer
- diagnosis of idiopathic, typical Parkinson disease according to the United Kingdom Brain Bank Criteria;
- Hoehn \& Yahr stages 2-3 (mild to moderate disease severity);
- stable on all PD medications for at least 2 months prior to study entry;
- a score of 1 or less on item # 7 on the New Freezing of Gait Questionnaire; and
- score of ≥ 1 on the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III Item #10 indicating observable gait impairment.
Who cannot join
- diagnosis of any other neurological condition;
- 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 (i.e., uncontrolled congestive heart failure, myocardial infarction in past 6 months, complex cardiac arrhythmias, significant left ventricular dysfunction, dyspnea on exertion, chest pain or pressure, resting tachycardia (>100 beats/min); uncontrolled BP (resting systolic BP >160 mmHg or diastolic BP >100 mmHg));
- orthopedic problems in the lower extremities or spine that may limit walking (i.e., severe arthritis, spinal stenosis);
- contraindications for magnetic resonance imaging (e.g., metallic implants); or
- uncontrolled tremor or dyskinesia (while on PD medications if applicable).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine Program in Physical Therapy
St Louis, Missouri, 63110
About this study
Official title: Sing for Your Saunter: Using Self-generated Rhythmic Cues to Enhance Gait in Parkinson's
Older adults, and particularly those with Parkinson disease (PD), may experience walking difficulties that negatively impact their daily function and quality of life. This project will examine the impact of music and mentally singing on walking performance, with a goal of understanding what types of rhythmic cues are most helpful. Our pilot work suggests that imagined, mental singing (i.e., singing in your head) while while walking helps people walk faster with greater stability, whereas walking to music also helps people walk faster but with reduced stability.
In Aim 1, the investigators will compare walking while mentally singing to walking while listening to music, using personalized cues tailored to each person's walking performance. The investigators hypothesize stride time variability will be less in the mental singing condition compared to listening to music; and that mental singing and listening to music will improve gait speed similarly as compared to the uncued condition. The investigators will also test whether finger tapping, a rhythmic task similar to walking in many ways, responds similarly while mentally singing and listening to music.
In Aim 2, the investigator will investigate the brain mechanisms underlying the enhancements in movement performance seen with mental signing or listening to music. The investigators will use magnetic resonance imaging (MRI) to measure brain activity during finger tapping with and without various cues to understand which areas of the brain are more or less responsive to the cues. The investigators hypothesize individuals with PD will exhibit lesser activation of putamen and greater activation of cortical motor areas and cerebellum compared to controls in all tapping conditions; and internal, mental singing during tapping will elicit greater activation of the putamen and lesser activation of cortical motor areas in both groups compared to uncued tapping and tapping while listening to music.
Read the detailed description
During this observational study, all participants will attend two visits 4-10 days apart. At the first visit, all participants (participants with PD and age-matched controls) will wear wearable sensors during the following tasks: walking with no cues; walking while listening to music; and walking while mentally singing. The wearable sensors will measure gait parameters including gait speed and stride time variability. All participants will also conduct the following tasks while finger tapping on a keyboard: tapping with no cues; tapping while listening to music; and tapping while mentally singing.
At the second visit, all participants (participants with PD and age-matched controls) will perform the following tasks during imaging: uncued tapping; listening to music (no tapping); mentally singing (no tapping); listening to music and tapping; and mentally singing and tapping.
- Conditions
- Parkinson Disease
- Being tested
- Mentally singing, Listening to music
- Keywords
- parkinson disease, music, imaging, mental singing, gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentally singingBehavioural
All participants (people with PD and age-matched controls) sing their song in their head and match their footfalls or finger tapping to the beat.
Listening to musicBehavioural
All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat.
| Study group | Role | What they receive |
|---|---|---|
| Self cueing | Experimental | People living with Parkinson disease and controls walking with self-generated rhythmic cues. Receives: Behavioral: Mentally singing; Behavioral: Listening to music |
| External cueing | Active comparator | People living with Parkinson disease and controls walking to external rhythmic cues (i.e., music). Receives: Behavioral: Mentally singing; Behavioral: Listening to music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Measured with wearable sensors by APDM Wearable Technology
Measured: Baseline
Stride Length Variability
Measured with wearable sensors by APDM Wearable Technology
Measured: Baseline
Secondary outcomes (1)
Brain Activity (BOLD Signal)
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 no cue (uncued), moving to the beat during self cueing (mental singing) and moving to the best 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start9 Mar 2020
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Gammon M Earhart, Washington University School of Medicine
- Investigators
- Gammon Earhart, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246476
- Sponsor's protocol ID
- 201908117
- Other IDs
- 1R61AT010753-01
- Acronym
- SFYS
- Status last verified
- Jun 2025
- First submitted
- 24 Jan 2020
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harrison EC, Tueth LE, Haussler AM, Rawson KS, Earhart GM. Personalized Auditory Rhythmic Cues to Optimize Gait in Older Adults and People With Parkinson Disease. J Neurol Phys Ther. 2025 Jul 1;49(3):162-170. doi: 10.1097/NPT.0000000000000508. Epub 2025 Feb 27.
PubMed 39913311
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. 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
- NCT04246476
- Acronym / sponsor ID
- SFYS / 201908117
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, music, imaging, mental singing, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older adults, and particularly those with Parkinson disease (PD), may experience walking difficulties that negatively impact their daily function and quality of life. This project will examine the impact of music and mentally singing on walking performance, with a goal of understanding what types of rhythmic cues are most helpful. Our pilot work suggests that imagined, mental singing (i.e., singing in your head) while while walking helps people walk faster with greater stability, whereas walking to music also helps people walk faster but with reduced stability.
In Aim 1, the investigators will compare walking while mentally singing to walking while listening to music, using personalized cues tailored to each person's walking performance. The investigators hypothesize stride time variability will be less in the mental singing condition compared to listening to music; and that mental singing and listening to music will improve gait speed similarly as compared to the uncued condition. The investigators will also test whether finger tapping, a rhythmic task similar to walking in many ways, responds similarly while mentally singing and listening to music.
In Aim 2, the investigator will investigate the brain mechanisms underlying the enhancements in movement performance seen with mental signing or listening to music. The investigators will use magnetic resonance imaging (MRI) to measure brain activity during finger tapping with and without various cues to understand which areas of the brain are more or less responsive to the cues. The investigators hypothesize individuals with PD will exhibit lesser activation of putamen and greater activation of cortical motor areas and cerebellum compared to controls in all tapping conditions; and internal, mental singing during tapping will elicit greater activation of the putamen and lesser activation of cortical motor areas in both groups compared to uncued tapping and tapping while listening to music.
Detailed description
During this observational study, all participants will attend two visits 4-10 days apart. At the first visit, all participants (participants with PD and age-matched controls) will wear wearable sensors during the following tasks: walking with no cues; walking while listening to music; and walking while mentally singing. The wearable sensors will measure gait parameters including gait speed and stride time variability. All participants will also conduct the following tasks while finger tapping on a keyboard: tapping with no cues; tapping while listening to music; and tapping while mentally singing.
At the second visit, all participants (participants with PD and age-matched controls) will perform the following tasks during imaging: uncued tapping; listening to music (no tapping); mentally singing (no tapping); listening to music and tapping; and mentally singing and tapping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self cueing | Experimental | Behavioral: Mentally singing, Behavioral: Listening to musicPeople living with Parkinson disease and controls walking with self-generated rhythmic cues. |
| External cueing | Active comparator | Behavioral: Mentally singing, Behavioral: Listening to musicPeople living with Parkinson disease and controls walking to external rhythmic cues (i.e., music). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- at least 30 years of age;
- willing and able to provide informed consent;
- right-handed or ambidextrous;
- normal hearing;
- weight less than 250 lbs; and
Key exclusion criteria (7 listed)
- diagnosis of any other neurological condition;
- 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 (i.e., uncontrolled congestive heart failure, myocardial infarction in past 6 months, complex cardiac arrhythmias, significant left ventricular dysfunction, dyspnea on exertion, chest pain or pressure, resting tachycardia (>100 beats/min); uncontrolled BP (resting systolic BP >160 mmHg or diastolic BP >100 mmHg));
- orthopedic problems in the lower extremities or spine that may limit walking (i.e., severe arthritis, spinal stenosis);
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 |
|---|---|---|
| Mentally singingAll participants (people with PD and age-matched controls) sing their song in their head and match their footfalls or finger tapping to the beat. | Behavioural | External cueing, Self cueing |
| Listening to musicAll participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat. | Behavioural | External cueing, Self cueing |
Primary outcome
Gait Speed
Time frame: Baseline
Measured with wearable sensors by APDM Wearable Technology
Stride Length Variability
Time frame: Baseline
Measured with wearable sensors by APDM Wearable Technology
1 secondary outcome
Brain Activity (BOLD Signal)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39913311Harrison EC, Tueth LE, Haussler AM, Rawson KS, Earhart GM. Personalized Auditory Rhythmic Cues to Optimize Gait in Older Adults and People With Parkinson Disease. J Neurol Phys Ther. 2025 Jul 1;49(3):162-170. doi: 10.1097/NPT.0000000000000508. Epub 2025 Feb 27.
- Individual participant dataSharing planned: No
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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.
Gammon Earhart principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentally singing and Listening to music 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 11 inclusion and 7 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 1 Jul 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). 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). 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 NCT04246476, which also lists 1 linked publication.
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 1 Jul 2025.