Sing for Your Saunter - Dementia Supplement

Parkinson Disease Clinical Trial

— SFYS-D  

Official title:

Sing for Your Saunter: Using Self-generated Rhythmic Cues to Enhance Gait in Parkinson's - Dementia Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518917
• Other study ID #: AT010753-02S1
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: June 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

During this observational study, participants will attend one visit in the laboratory. The visit will include participants wearing wearable sensors during the following tasks: walking with no cues (UNCUED), walking while listening to music (MUSIC), walking while singing out loud (SINGING), and walking while mentally singing (MENTAL SINGING). The wearable sensors will measure gait parameters including gait speed, stride length, and stride time variability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Parkinson Disease
• Parkinson Disease Dementia

Intervention

Behavioral:
• Mentally Singing
Participants sing their song in their head and match their footfalls to the beat.
• Listening to music
Participants listen to their song and match their footfalls to the beat.
• Singing
Participants will sing their song out loud and match their footfalls to the beat.

Locations

Country	Name	City	State
United States	Washington University School of Medicine Program in Physical Therapy	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stride Time Variability	Measured with wearable sensors by APDM Wearable Technology	Baseline
Primary	Stride length	Measured with wearable sensors by APDM Wearable Technology	Baseline