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Sing for Your Saunter

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04246476
Acronym
SFYS
Enrollment
67
Registered
2020-01-29
Start date
2020-03-09
Completion date
2023-01-20
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

parkinson disease, music, imaging, mental singing, gait

Brief 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 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.

Interventions

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.

All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

for all participants: * 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. Inclusion criteria for participants with PD also include: * 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.

Exclusion criteria

for both groups include: * 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).

Design outcomes

Primary

MeasureTime frameDescription
Gait SpeedBaselineMeasured with wearable sensors by APDM Wearable Technology
Stride Length VariabilityBaselineMeasured with wearable sensors by APDM Wearable Technology

Secondary

MeasureTime frameDescription
Brain Activity (BOLD Signal)BaselineWe 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.

Countries

United States

Participant flow

Pre-assignment details

All participants in both groups completed all conditions (i.e., uncued, mental singing and music) at all tempos (i.e., 90, 100, 110 and 120% of baseline uncued cadence).

Participants by arm

ArmCount
Parkinson Group
People living with Parkinson disease walking with and without rhythmic cues. Mentally singing: 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. Music: All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat. Uncued: no music and no singing
29
Healthy Control Group
Healthy controls walking with and without rhythmic cues. Mentally singing: 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. Music: All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat. Uncued: no music and no singing
29
Total58

Baseline characteristics

CharacteristicParkinson GroupHealthy Control GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
17 Participants16 Participants33 Participants
Age, Categorical
Between 18 and 65 years
12 Participants13 Participants25 Participants
Mini Mental Status Exam29 units on a scale29 units on a scale29 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
28 Participants28 Participants56 Participants
Sex: Female, Male
Female
15 Participants15 Participants30 Participants
Sex: Female, Male
Male
14 Participants14 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 29
other
Total, other adverse events
0 / 290 / 29
serious
Total, serious adverse events
0 / 290 / 29

Outcome results

Primary

Gait Speed

Measured with wearable sensors by APDM Wearable Technology

Time frame: Baseline

Population: Results are presented separately for each group and for each cueing condition (uncued, music or mental singing) and tempo (90, 100, 110, 120%).

ArmMeasureGroupValue (MEAN)Dispersion
Parkinson Disease GroupGait SpeedMental singing 120%1.27 meters per secondStandard Deviation 0.17
Parkinson Disease GroupGait SpeedMusic 100%1.13 meters per secondStandard Deviation 0.16
Parkinson Disease GroupGait SpeedMusic 90%1.04 meters per secondStandard Deviation 0.15
Parkinson Disease GroupGait SpeedMental singing 100%1.13 meters per secondStandard Deviation 0.17
Parkinson Disease GroupGait SpeedUncued1.12 meters per secondStandard Deviation 0.16
Parkinson Disease GroupGait SpeedMusic 110%1.22 meters per secondStandard Deviation 0.19
Parkinson Disease GroupGait SpeedMental singing 90%1.16 meters per secondStandard Deviation 0.16
Parkinson Disease GroupGait SpeedMental singing 110%1.21 meters per secondStandard Deviation 0.17
Parkinson Disease GroupGait SpeedMusic 120%1.29 meters per secondStandard Deviation 0.2
Healthy ControlsGait SpeedMental singing 110%1.23 meters per secondStandard Deviation 0.16
Healthy ControlsGait SpeedMusic 120%1.31 meters per secondStandard Deviation 0.17
Healthy ControlsGait SpeedMental singing 120%1.29 meters per secondStandard Deviation 0.15
Healthy ControlsGait SpeedUncued1.17 meters per secondStandard Deviation 0.13
Healthy ControlsGait SpeedMusic 90%1.09 meters per secondStandard Deviation 0.15
Healthy ControlsGait SpeedMental singing 90%1.11 meters per secondStandard Deviation 0.13
Healthy ControlsGait SpeedMusic 100%1.17 meters per secondStandard Deviation 0.15
Healthy ControlsGait SpeedMental singing 100%1.19 meters per secondStandard Deviation 0.15
Healthy ControlsGait SpeedMusic 110%1.24 meters per secondStandard Deviation 0.16
Primary

Stride Length Variability

Measured with wearable sensors by APDM Wearable Technology

Time frame: Baseline

Population: Results are presented separately for each group in each condition (uncued, music, mental singing) at each tempo (90, 100, 110, 120% of uncued).

ArmMeasureGroupValue (MEAN)Dispersion
Parkinson Disease GroupStride Length VariabilityUncued.014 coefficient of variationStandard Deviation 0.003
Parkinson Disease GroupStride Length VariabilityMusic 110%.014 coefficient of variationStandard Deviation 0.009
Parkinson Disease GroupStride Length VariabilityMusic 100%.013 coefficient of variationStandard Deviation 0.005
Parkinson Disease GroupStride Length VariabilityMental singing 110%.012 coefficient of variationStandard Deviation 0.007
Parkinson Disease GroupStride Length VariabilityMental singing 90%.013 coefficient of variationStandard Deviation 0.006
Parkinson Disease GroupStride Length VariabilityMusic 120%.016 coefficient of variationStandard Deviation 0.009
Parkinson Disease GroupStride Length VariabilityMental singing 100%.013 coefficient of variationStandard Deviation 0.005
Parkinson Disease GroupStride Length VariabilityMental singing 120%.012 coefficient of variationStandard Deviation 0.005
Parkinson Disease GroupStride Length VariabilityMusic 90%.015 coefficient of variationStandard Deviation 0.005
Healthy ControlsStride Length VariabilityMental singing 120%.011 coefficient of variationStandard Deviation 0.005
Healthy ControlsStride Length VariabilityUncued.013 coefficient of variationStandard Deviation 0.005
Healthy ControlsStride Length VariabilityMusic 90%.014 coefficient of variationStandard Deviation 0.003
Healthy ControlsStride Length VariabilityMental singing 90%.012 coefficient of variationStandard Deviation 0.003
Healthy ControlsStride Length VariabilityMusic 100%.014 coefficient of variationStandard Deviation 0.004
Healthy ControlsStride Length VariabilityMental singing 100%.011 coefficient of variationStandard Deviation 0.002
Healthy ControlsStride Length VariabilityMusic 110%.014 coefficient of variationStandard Deviation 0.004
Healthy ControlsStride Length VariabilityMental singing 110%.012 coefficient of variationStandard Deviation 0.003
Healthy ControlsStride Length VariabilityMusic 120%.014 coefficient of variationStandard Deviation 0.006
Secondary

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.

Time frame: Baseline

Population: Results are presented separately for each group in each condition (uncued, music, mental singing).

ArmMeasureGroupValue (MEAN)Dispersion
Parkinson Disease GroupBrain Activity (BOLD Signal)Uncued Left Putamen-.054 Beta weights (arbitrary units)Standard Deviation 0.217
Parkinson Disease GroupBrain Activity (BOLD Signal)Uncued Right Putamen-.053 Beta weights (arbitrary units)Standard Deviation 0.181
Parkinson Disease GroupBrain Activity (BOLD Signal)Uncued Bilateral Primary Somatosensory Cortex.069 Beta weights (arbitrary units)Standard Deviation 0.26
Parkinson Disease GroupBrain Activity (BOLD Signal)Music Left Putamen-.027 Beta weights (arbitrary units)Standard Deviation 0.268
Parkinson Disease GroupBrain Activity (BOLD Signal)Music Right Putamen-.069 Beta weights (arbitrary units)Standard Deviation 0.199
Parkinson Disease GroupBrain Activity (BOLD Signal)Music Bilateral Auditory Cortex.102 Beta weights (arbitrary units)Standard Deviation 0.24
Parkinson Disease GroupBrain Activity (BOLD Signal)Music Bilateral Primary Somatosensory Cortex.096 Beta weights (arbitrary units)Standard Deviation 0.183
Parkinson Disease GroupBrain Activity (BOLD Signal)Mental singing Left Putamen-.0001 Beta weights (arbitrary units)Standard Deviation 0.272
Parkinson Disease GroupBrain Activity (BOLD Signal)Mental Singing Right Putamen-.063 Beta weights (arbitrary units)Standard Deviation 0.25
Parkinson Disease GroupBrain Activity (BOLD Signal)Mental singing Bilateral Primary Somatosensory Cortex.177 Beta weights (arbitrary units)Standard Deviation 0.291
Healthy ControlsBrain Activity (BOLD Signal)Mental singing Left Putamen.114 Beta weights (arbitrary units)Standard Deviation 0.296
Healthy ControlsBrain Activity (BOLD Signal)Uncued Left Putamen-.017 Beta weights (arbitrary units)Standard Deviation 0.189
Healthy ControlsBrain Activity (BOLD Signal)Music Bilateral Auditory Cortex.246 Beta weights (arbitrary units)Standard Deviation 0.357
Healthy ControlsBrain Activity (BOLD Signal)Uncued Right Putamen-.053 Beta weights (arbitrary units)Standard Deviation 0.143
Healthy ControlsBrain Activity (BOLD Signal)Mental singing Bilateral Primary Somatosensory Cortex.258 Beta weights (arbitrary units)Standard Deviation 0.394
Healthy ControlsBrain Activity (BOLD Signal)Uncued Bilateral Primary Somatosensory Cortex.139 Beta weights (arbitrary units)Standard Deviation 0.221
Healthy ControlsBrain Activity (BOLD Signal)Music Bilateral Primary Somatosensory Cortex.218 Beta weights (arbitrary units)Standard Deviation 0.279
Healthy ControlsBrain Activity (BOLD Signal)Music Left Putamen.091 Beta weights (arbitrary units)Standard Deviation 0.293
Healthy ControlsBrain Activity (BOLD Signal)Mental Singing Right Putamen.024 Beta weights (arbitrary units)Standard Deviation 0.279
Healthy ControlsBrain Activity (BOLD Signal)Music Right Putamen.035 Beta weights (arbitrary units)Standard Deviation 0.233

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026