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Sing for Your Saunter - Dementia Supplement (SFYS-D)

Primary Purpose

Parkinson Disease, Parkinson Disease Dementia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mentally Singing

Listening to music

Singing

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Parkinson disease, Music, Mental singing, Gait

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Washington University School of Medicine Program in Physical Therapy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Parkinson disease plus dementia

Arm Description

Participants will have a diagnosis of Parkinson disease plus dementia.

Outcomes

Primary Outcome Measures

Stride Time Variability

Measured with wearable sensors by APDM Wearable Technology

Stride length

Measured with wearable sensors by APDM Wearable Technology

Secondary Outcome Measures

Full Information

NCT ID

NCT04518917

First Posted

August 15, 2020

Last Updated

June 14, 2023

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04518917

Brief Title

Sing for Your Saunter - Dementia Supplement

Acronym

SFYS-D

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

April 19, 2021 (Actual)

Primary Completion Date

May 15, 2023 (Actual)

Study Completion Date

May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Parkinson Disease Dementia

Keywords

Parkinson disease, Music, Mental singing, Gait

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Parkinson disease plus dementia

Arm Type

Other

Arm Description

Participants will have a diagnosis of Parkinson disease plus dementia.

Intervention Type

Behavioral

Intervention Name(s)

Mentally Singing

Intervention Description

Participants sing their song in their head and match their footfalls to the beat.

Intervention Type

Behavioral

Intervention Name(s)

Listening to music

Intervention Description

Participants listen to their song and match their footfalls to the beat.

Intervention Type

Behavioral

Intervention Name(s)

Singing

Intervention Description

Participants will sing their song out loud and match their footfalls to the beat.

Primary Outcome Measure Information:

Title

Stride Time Variability

Description

Measured with wearable sensors by APDM Wearable Technology

Time Frame

Baseline

Title

Stride length

Description

Measured with wearable sensors by APDM Wearable Technology

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gammon Earhart

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine Program in Physical Therapy

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Sing for Your Saunter - Dementia Supplement

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