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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self cueing | Experimental | Self-cueing training using singing, one hour sessions twice weekly for 12 weeks. |
|
| External cueing | Experimental | External cueing using music, one hour sessions twice weekly for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self Cueing Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Speed | How quickly someone walks | Baseline and 12 weeks |
| MRI Bold Beta Weights | 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. | Baseline and 12 weeks |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
Data for individual participants available by request. Only de-identified data will be shared and only for individuals who consent to have their data shared with people who are not part of the original research team.
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Nothing to report
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Self Cueing | Self-cueing training using singing, one hour sessions twice weekly for 12 weeks. |
| FG001 | External Cueing | External cueing using music, one hour sessions twice weekly for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Self Cueing | Self-cueing training using singing, one hour sessions twice weekly for 12 weeks. |
| BG001 | External Cueing | External cueing using music, one hour sessions twice weekly for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at start of study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gait Speed | How quickly someone walks | Posted | Mean | Standard Deviation | meters per second | Baseline and 12 weeks |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self Cueing | Self-cueing training using singing, one hour sessions twice weekly for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | All falls were at home or in the community and were unrelated to receiving the intervention. |
Nothing to report
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gammon Earhart | Washington University in St. Louis | 314-286-1407 | earhartg@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2023 | Jan 16, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| External Cueing Training | Behavioral | 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. |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex as self-reported by participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race as self-reported by participants | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity as self-reported by participants | Count of Participants | Participants |
|
| Hoehn & Yahr Stage | The Hoehn & Yahr Stage is a measure of Parkinson disease severity that ranges from 1 to 5 with 1 being the most mild and 5 the most severe. | Count of Participants | Participants |
|
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| Primary | MRI Bold Beta Weights | 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. | 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. | Posted | Dec 2026 | Mean | Standard Deviation | Beta weights (arbitrary units) | Baseline and 12 weeks |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 15 |
| 38 |
| EG001 | External Cueing | External cueing using music, one hour sessions twice weekly for 12 weeks. | 0 | 36 | 0 | 36 | 7 | 36 |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Skin condition | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Fractures were unrelated to intervention and included a car accident, fall while shoveling driveway and kicking an object while working on home repairs. |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Feeling unwell | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Variously attributed to a cold, difficulty sleeping, not eating well. |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Baseline left putamen activity when tapping during mental singing |
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| 12 weeks left putamen activity when tapping to mental singing |
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| Baseline bilateral anterior cerebellum activity when tapping during mental singing |
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| 12 weeks bilateral anterior cerebellum activity when tapping during mental singing |
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| Baseline bilateral auditory cortex activity when tapping to music |
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| 12 week bilateral auditory cortex activity when tapping to music |
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| Baseline left putamen activity when tapping to music |
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| 12 week left putamen activity when tapping to music |
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| Baseline bilateral anterior cerebellum activity when tapping to music |
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| 12 week bilateral anterior cerebellum activity when tapping to music |
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