Trial Outcomes & Findings for Sing for Your Saunter (NCT NCT04246476)
NCT ID: NCT04246476
Last Updated: 2025-07-01
Results Overview
Measured with wearable sensors by APDM Wearable Technology
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Baseline
Results posted on
2025-07-01
Participant Flow
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).
Participant milestones
| Measure |
Parkinson Disease Group
People living with Parkinson disease
|
Healthy Controls
Healthy controls age-matched to Parkinson disease group
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sing for Your Saunter
Baseline characteristics by cohort
| Measure |
Parkinson Group
n=29 Participants
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
|
Healthy Control Group
n=29 Participants
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
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Mini Mental Status Exam
|
29 units on a scale
n=99 Participants
|
29 units on a scale
n=107 Participants
|
29 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Results are presented separately for each group and for each cueing condition (uncued, music or mental singing) and tempo (90, 100, 110, 120%).
Measured with wearable sensors by APDM Wearable Technology
Outcome measures
| Measure |
Parkinson Disease Group
n=29 Participants
People with Parkinson disease
|
Healthy Controls
n=29 Participants
Healthy controls age-matched to the Parkinson disease group
|
|---|---|---|
|
Gait Speed
Uncued
|
1.12 meters per second
Standard Deviation .16
|
1.17 meters per second
Standard Deviation .13
|
|
Gait Speed
Music 90%
|
1.04 meters per second
Standard Deviation .15
|
1.09 meters per second
Standard Deviation .15
|
|
Gait Speed
Mental singing 90%
|
1.16 meters per second
Standard Deviation .16
|
1.11 meters per second
Standard Deviation .13
|
|
Gait Speed
Music 100%
|
1.13 meters per second
Standard Deviation .16
|
1.17 meters per second
Standard Deviation .15
|
|
Gait Speed
Mental singing 100%
|
1.13 meters per second
Standard Deviation .17
|
1.19 meters per second
Standard Deviation .15
|
|
Gait Speed
Music 110%
|
1.22 meters per second
Standard Deviation .19
|
1.24 meters per second
Standard Deviation .16
|
|
Gait Speed
Mental singing 110%
|
1.21 meters per second
Standard Deviation .17
|
1.23 meters per second
Standard Deviation .16
|
|
Gait Speed
Music 120%
|
1.29 meters per second
Standard Deviation .2
|
1.31 meters per second
Standard Deviation .17
|
|
Gait Speed
Mental singing 120%
|
1.27 meters per second
Standard Deviation .17
|
1.29 meters per second
Standard Deviation .15
|
PRIMARY outcome
Timeframe: BaselinePopulation: Results are presented separately for each group in each condition (uncued, music, mental singing) at each tempo (90, 100, 110, 120% of uncued).
Measured with wearable sensors by APDM Wearable Technology
Outcome measures
| Measure |
Parkinson Disease Group
n=29 Participants
People with Parkinson disease
|
Healthy Controls
n=29 Participants
Healthy controls age-matched to the Parkinson disease group
|
|---|---|---|
|
Stride Length Variability
Music 120%
|
.016 coefficient of variation
Standard Deviation .009
|
.014 coefficient of variation
Standard Deviation .006
|
|
Stride Length Variability
Mental singing 120%
|
.012 coefficient of variation
Standard Deviation .005
|
.011 coefficient of variation
Standard Deviation .005
|
|
Stride Length Variability
Uncued
|
.014 coefficient of variation
Standard Deviation .003
|
.013 coefficient of variation
Standard Deviation .005
|
|
Stride Length Variability
Music 90%
|
.015 coefficient of variation
Standard Deviation .005
|
.014 coefficient of variation
Standard Deviation .003
|
|
Stride Length Variability
Mental singing 90%
|
.013 coefficient of variation
Standard Deviation .006
|
.012 coefficient of variation
Standard Deviation .003
|
|
Stride Length Variability
Music 100%
|
.013 coefficient of variation
Standard Deviation .005
|
.014 coefficient of variation
Standard Deviation .004
|
|
Stride Length Variability
Mental singing 100%
|
.013 coefficient of variation
Standard Deviation .005
|
.011 coefficient of variation
Standard Deviation .002
|
|
Stride Length Variability
Music 110%
|
.014 coefficient of variation
Standard Deviation .009
|
.014 coefficient of variation
Standard Deviation .004
|
|
Stride Length Variability
Mental singing 110%
|
.012 coefficient of variation
Standard Deviation .007
|
.012 coefficient of variation
Standard Deviation .003
|
SECONDARY outcome
Timeframe: BaselinePopulation: Results are presented separately for each group in each condition (uncued, music, mental singing).
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.
Outcome measures
| Measure |
Parkinson Disease Group
n=27 Participants
People with Parkinson disease
|
Healthy Controls
n=28 Participants
Healthy controls age-matched to the Parkinson disease group
|
|---|---|---|
|
Brain Activity (BOLD Signal)
Music Left Putamen
|
-.027 Beta weights (arbitrary units)
Standard Deviation .268
|
.091 Beta weights (arbitrary units)
Standard Deviation .293
|
|
Brain Activity (BOLD Signal)
Music Right Putamen
|
-.069 Beta weights (arbitrary units)
Standard Deviation .199
|
.035 Beta weights (arbitrary units)
Standard Deviation .233
|
|
Brain Activity (BOLD Signal)
Music Bilateral Primary Somatosensory Cortex
|
.096 Beta weights (arbitrary units)
Standard Deviation .183
|
.218 Beta weights (arbitrary units)
Standard Deviation .279
|
|
Brain Activity (BOLD Signal)
Mental singing Bilateral Primary Somatosensory Cortex
|
.177 Beta weights (arbitrary units)
Standard Deviation .291
|
.258 Beta weights (arbitrary units)
Standard Deviation .394
|
|
Brain Activity (BOLD Signal)
Uncued Left Putamen
|
-.054 Beta weights (arbitrary units)
Standard Deviation .217
|
-.017 Beta weights (arbitrary units)
Standard Deviation .189
|
|
Brain Activity (BOLD Signal)
Uncued Right Putamen
|
-.053 Beta weights (arbitrary units)
Standard Deviation .181
|
-.053 Beta weights (arbitrary units)
Standard Deviation .143
|
|
Brain Activity (BOLD Signal)
Uncued Bilateral Primary Somatosensory Cortex
|
.069 Beta weights (arbitrary units)
Standard Deviation .260
|
.139 Beta weights (arbitrary units)
Standard Deviation .221
|
|
Brain Activity (BOLD Signal)
Music Bilateral Auditory Cortex
|
.102 Beta weights (arbitrary units)
Standard Deviation .240
|
.246 Beta weights (arbitrary units)
Standard Deviation .357
|
|
Brain Activity (BOLD Signal)
Mental singing Left Putamen
|
-.0001 Beta weights (arbitrary units)
Standard Deviation .272
|
.114 Beta weights (arbitrary units)
Standard Deviation .296
|
|
Brain Activity (BOLD Signal)
Mental Singing Right Putamen
|
-.063 Beta weights (arbitrary units)
Standard Deviation .250
|
.024 Beta weights (arbitrary units)
Standard Deviation .279
|
Adverse Events
Parkinson Disease Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place