Parkinson Disease
Conditions
Brief 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 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.
Interventions
BEHAVIORALSelf Cueing Training
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.
BEHAVIORALExternal Cueing Training
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.
Sponsors
Washington University School of Medicine
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. at least 30 years of age 2. diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria 3. Hoehn \& Yahr stages 2-3 (mild to moderate disease severity) 4. 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
Exclusion criteria
1. diagnosis of any other neurological condition 2. a score of 2 or greater on item # 3 on the freezing of gait questionnaire 3. significant cognitive impairment 4. unstable medical or concomitant illnesses or psychiatric conditions which, in the opinion of the investigators, would preclude successful participation 5. cardiac problems that interfere with ability to safely participate 6. orthopedic problems in the lower extremities or spine that may limit walking 7. contraindications for magnetic resonance imaging 8. unable to walk for 10 continuous minutes independently 9. left-handed 10. uncontrolled tremor or dyskinesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed | Baseline and 12 weeks | How quickly someone walks |
| MRI Bold Beta Weights | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Nothing to report
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hoehn & Yahr Stage Hoehn & Yahr Stage 2 | 32 Participants |
| Hoehn & Yahr Stage Hoehn & Yahr Stage 3 | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 36 |
| other Total, other adverse events | 15 / 38 | 7 / 36 |
| serious Total, serious adverse events | 0 / 38 | 0 / 36 |
Outcome results
None listed