Trial Outcomes & Findings for Sing For Your Saunter Part 2 R33 (NCT NCT06115382)
NCT ID: NCT06115382
Last Updated: 2026-04-02
Results Overview
How quickly someone walks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2026-04-02
Participant Flow
Participants were recruited from our movement disorders clinic and through presentations at local support groups and conferences. The study was also advertised on social media.
Nothing to report
Participant milestones
| Measure |
Self Cueing
Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.
|
External Cueing
External cueing using music, one hour sessions twice weekly for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
36
|
|
Overall Study
COMPLETED
|
28
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sing For Your Saunter Part 2 R33
Baseline characteristics by cohort
| Measure |
Self Cueing
n=38 Participants
Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.
|
External Cueing
n=36 Participants
External cueing using music, one hour sessions twice weekly for 12 weeks.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 7.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
16 Participants
n=5 Participants
|
36 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=5 Participants
|
38 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
33 Participants
n=5 Participants
|
69 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
36 Participants
n=5 Participants
|
74 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Hoehn & Yahr Stage
Hoehn & Yahr Stage 2
|
35 Participants
n=5 Participants
|
32 Participants
n=5 Participants
|
67 Participants
n=10 Participants
|
|
Hoehn & Yahr Stage
Hoehn & Yahr Stage 3
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksHow quickly someone walks
Outcome measures
| Measure |
Self Cueing
n=28 Participants
Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.
|
External Cueing
n=33 Participants
External cueing using music, one hour sessions twice weekly for 12 weeks.
|
|---|---|---|
|
Gait Speed
Baseline gait speed
|
1.09 meters per second
Standard Deviation 0.20
|
1.04 meters per second
Standard Deviation 0.23
|
|
Gait Speed
Gait speed at 12 weeks
|
1.15 meters per second
Standard Deviation 0.21
|
1.08 meters per second
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Self Cueing
n=19 Participants
Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.
|
External Cueing
n=24 Participants
External cueing using music, one hour sessions twice weekly for 12 weeks.
|
|---|---|---|
|
MRI Bold Beta Weights
12 week left putamen activity when tapping to music
|
-.039 Beta weights (arbitrary units)
Standard Deviation .151
|
-.045 Beta weights (arbitrary units)
Standard Deviation .209
|
|
MRI Bold Beta Weights
Baseline bilateral auditory cortex activity when tapping during mental singing
|
-.892 Beta weights (arbitrary units)
Standard Deviation .323
|
-.764 Beta weights (arbitrary units)
Standard Deviation .323
|
|
MRI Bold Beta Weights
12 weeks bilateral auditory cortex activity when tapping during mental singing
|
-.854 Beta weights (arbitrary units)
Standard Deviation .277
|
-.674 Beta weights (arbitrary units)
Standard Deviation .378
|
|
MRI Bold Beta Weights
Baseline left putamen activity when tapping during mental singing
|
-.018 Beta weights (arbitrary units)
Standard Deviation .197
|
-.023 Beta weights (arbitrary units)
Standard Deviation .210
|
|
MRI Bold Beta Weights
12 weeks left putamen activity when tapping to mental singing
|
.060 Beta weights (arbitrary units)
Standard Deviation .186
|
-.093 Beta weights (arbitrary units)
Standard Deviation .156
|
|
MRI Bold Beta Weights
Baseline bilateral anterior cerebellum activity when tapping during mental singing
|
-.023 Beta weights (arbitrary units)
Standard Deviation .293
|
.014 Beta weights (arbitrary units)
Standard Deviation .220
|
|
MRI Bold Beta Weights
12 weeks bilateral anterior cerebellum activity when tapping during mental singing
|
.044 Beta weights (arbitrary units)
Standard Deviation .275
|
-.035 Beta weights (arbitrary units)
Standard Deviation .199
|
|
MRI Bold Beta Weights
Baseline bilateral auditory cortex activity when tapping to music
|
.492 Beta weights (arbitrary units)
Standard Deviation .286
|
.249 Beta weights (arbitrary units)
Standard Deviation .500
|
|
MRI Bold Beta Weights
12 week bilateral auditory cortex activity when tapping to music
|
.324 Beta weights (arbitrary units)
Standard Deviation .236
|
.339 Beta weights (arbitrary units)
Standard Deviation .309
|
|
MRI Bold Beta Weights
Baseline left putamen activity when tapping to music
|
.097 Beta weights (arbitrary units)
Standard Deviation .197
|
-.035 Beta weights (arbitrary units)
Standard Deviation .178
|
|
MRI Bold Beta Weights
Baseline bilateral anterior cerebellum activity when tapping to music
|
.060 Beta weights (arbitrary units)
Standard Deviation .131
|
.047 Beta weights (arbitrary units)
Standard Deviation .230
|
|
MRI Bold Beta Weights
12 week bilateral anterior cerebellum activity when tapping to music
|
-.024 Beta weights (arbitrary units)
Standard Deviation .112
|
-.024 Beta weights (arbitrary units)
Standard Deviation .246
|
Adverse Events
Self Cueing
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
External Cueing
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Self Cueing
n=38 participants at risk
Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.
|
External Cueing
n=36 participants at risk
External cueing using music, one hour sessions twice weekly for 12 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
7.9%
3/38 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
2.8%
1/36 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
4/38 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
2.8%
1/36 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
5.3%
2/38 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
2.8%
1/36 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
|
Skin and subcutaneous tissue disorders
Skin condition
|
2.6%
1/38 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
2.8%
1/36 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
5.3%
2/38 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
2.8%
1/36 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/38 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
5.6%
2/36 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
|
Respiratory, thoracic and mediastinal disorders
Feeling unwell
|
7.9%
3/38 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
0.00%
0/36 • From enrollment to end of follow-up, up to 20 weeks.
Participants were asked about adverse events on a weekly basis during the period of the intervention. Any reported events were then documented on a standardized adverse events form that allowed us to collect information about the nature, severity, and relatedness of the event as well as any treatment received. Any open adverse events were followed up on each week during the period of intervention and each conversation again documented with an adverse event follow up form.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place