- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518917
Sing for Your Saunter - Dementia Supplement (SFYS-D)
Sing for Your Saunter: Using Self-generated Rhythmic Cues to Enhance Gait in Parkinson's - Dementia Supplement
Older adults, and particularly those with Parkinson disease (PD), may experience walking difficulties that negatively impact their daily function and quality of life. People that have PD plus dementia are also likely to experience walking difficulties. 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. Pilot work from the investigators suggests that imagined, mental singing (i.e., singing in 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 this study, the investigators will recruit people who have PD plus dementia. The investigators will compare walking while mentally singing, walking while singing out loud, and walking while listening to music, using personalized cues tailored to each person's walking performance. The investigators hypothesize temporal variability of gait will be lower in the mental singing and singing conditions compared to listening to music; and that mental singing, singing, and listening to music will elicit similar improvements in stride length.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Martha Hessler
- Phone Number: 3142861478
- Email: mjhessler@wustl.edu
Study Contact Backup
- Name: Kerri Rawson
- Phone Number: 3142731053
- Email: rawson@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine Program in Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- at least 30 years of age
- diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria
- Hoehn & Yahr stages 2-3 (mild to moderate disease severity)
- normal or corrected hearing
- stable on all PD medications for at least 2 months prior to study entry
- dementia as defined by a Clinical Dementia Rating (CDR) score of 0.5-1.0 (very mild to mild dementia)
- score of ≥ 1 on the MDS-UPDRS-III Item #10 indicating observable gait impairment
- a score of 1 or less on item #7 on the freezing of gait questionnaire
- able to walk for 10 continuous minutes independently
Exclusion Criteria:
- diagnosis of any other neurological condition
- 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)
- uncontrolled tremor or dyskinesia while on PD medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Parkinson disease plus dementia
Participants will have a diagnosis of Parkinson disease plus dementia.
|
Participants sing their song in their head and match their footfalls to the beat.
Participants listen to their song and match their footfalls to the beat.
Participants will sing their song out loud and match their footfalls to the beat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stride Time Variability
Time Frame: Baseline
|
Measured with wearable sensors by APDM Wearable Technology
|
Baseline
|
Stride length
Time Frame: Baseline
|
Measured with wearable sensors by APDM Wearable Technology
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gammon Earhart, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AT010753-02S1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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