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Sing for Your Saunter (SFYS)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mentally singing
Listening to music
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring parkinson disease, music, imaging, mental singing, gait

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for all participants:

  • at least 30 years of age;
  • willing and able to provide informed consent;
  • right-handed or ambidextrous;
  • normal hearing;
  • weight less than 250 lbs; and
  • able to walk for 10 continuous minutes independently.

Inclusion criteria for participants with PD also include:

  • diagnosis of idiopathic, typical Parkinson disease according to the United Kingdom Brain Bank Criteria;
  • Hoehn & Yahr stages 2-3 (mild to moderate disease severity);
  • stable on all PD medications for at least 2 months prior to study entry;
  • a score of 1 or less on item # 7 on the New Freezing of Gait Questionnaire; and
  • score of ≥ 1 on the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III Item #10 indicating observable gait impairment.

Exclusion Criteria for both groups include:

  • diagnosis of any other neurological condition;
  • significant cognitive impairment;
  • 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);
  • contraindications for magnetic resonance imaging (e.g., metallic implants); or
  • uncontrolled tremor or dyskinesia (while on PD medications if applicable).

Sites / Locations

  • Washington University School of Medicine Program in Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self cueing

External cueing

Arm Description

People living with Parkinson disease and controls walking with self-generated rhythmic cues.

People living with Parkinson disease and controls walking to external rhythmic cues (i.e., music).

Outcomes

Primary Outcome Measures

Stride Time Variability
Measured with wearable sensors by APDM Wearable Technology
Gait Speed
Measured with wearable sensors by APDM Wearable Technology

Secondary Outcome Measures

Blood Oxygen Level Dependent Signal (BOLD) during movement
Measure of the ratio of oxygenated to deoxygenated blood in the putamen, cortical motor areas, and cerebellum between individuals with PD and age-matched controls. Higher values indicate more brain activity in the brain areas.
Blood Oxygen Level Dependent Signal (BOLD) when listening to music vs. mentally singing
Measure of the ratio of oxygenated to deoxygenated blood in the putamen and cortical motor areas for both groups. Higher values indicate more brain activity in the brain areas during listening to music vs mentally singing.

Full Information

First Posted
January 24, 2020
Last Updated
June 14, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04246476
Brief Title
Sing for Your Saunter
Acronym
SFYS
Official Title
Sing for Your Saunter: Using Self-generated Rhythmic Cues to Enhance Gait in Parkinson's
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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. 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. Our pilot work suggests that imagined, mental singing (i.e., singing in your 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 Aim 1, the investigators will compare walking while mentally singing to walking while listening to music, using personalized cues tailored to each person's walking performance. The investigators hypothesize stride time variability will be less in the mental singing condition compared to listening to music; and that mental singing and listening to music will improve gait speed similarly as compared to the uncued condition. The investigators will also test whether finger tapping, a rhythmic task similar to walking in many ways, responds similarly while mentally singing and listening to music. In Aim 2, the investigator will investigate the brain mechanisms underlying the enhancements in movement performance seen with mental signing or listening to music. The investigators will use magnetic resonance imaging (MRI) to measure brain activity during finger tapping with and without various cues to understand which areas of the brain are more or less responsive to the cues. The investigators hypothesize individuals with PD will exhibit lesser activation of putamen and greater activation of cortical motor areas and cerebellum compared to controls in all tapping conditions; and internal, mental singing during tapping will elicit greater activation of the putamen and lesser activation of cortical motor areas in both groups compared to uncued tapping and tapping while listening to music.
Detailed Description
During this observational study, all participants will attend two visits 4-10 days apart. At the first visit, all participants (participants with PD and age-matched controls) will wear wearable sensors during the following tasks: walking with no cues; walking while listening to music; and walking while mentally singing. The wearable sensors will measure gait parameters including gait speed and stride time variability. All participants will also conduct the following tasks while finger tapping on a keyboard: tapping with no cues; tapping while listening to music; and tapping while mentally singing. At the second visit, all participants (participants with PD and age-matched controls) will perform the following tasks during imaging: uncued tapping; listening to music (no tapping); mentally singing (no tapping); listening to music and tapping; and mentally singing and tapping.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson disease, music, imaging, mental singing, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self cueing
Arm Type
Experimental
Arm Description
People living with Parkinson disease and controls walking with self-generated rhythmic cues.
Arm Title
External cueing
Arm Type
Active Comparator
Arm Description
People living with Parkinson disease and controls walking to external rhythmic cues (i.e., music).
Intervention Type
Behavioral
Intervention Name(s)
Mentally singing
Intervention Description
All participants (people with PD and age-matched controls) sing their song in their head and match their footfalls or finger tapping to the beat.
Intervention Type
Behavioral
Intervention Name(s)
Listening to music
Intervention Description
All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat.
Primary Outcome Measure Information:
Title
Stride Time Variability
Description
Measured with wearable sensors by APDM Wearable Technology
Time Frame
Baseline
Title
Gait Speed
Description
Measured with wearable sensors by APDM Wearable Technology
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Blood Oxygen Level Dependent Signal (BOLD) during movement
Description
Measure of the ratio of oxygenated to deoxygenated blood in the putamen, cortical motor areas, and cerebellum between individuals with PD and age-matched controls. Higher values indicate more brain activity in the brain areas.
Time Frame
Baseline
Title
Blood Oxygen Level Dependent Signal (BOLD) when listening to music vs. mentally singing
Description
Measure of the ratio of oxygenated to deoxygenated blood in the putamen and cortical motor areas for both groups. Higher values indicate more brain activity in the brain areas during listening to music vs mentally singing.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for all participants: at least 30 years of age; willing and able to provide informed consent; right-handed or ambidextrous; normal hearing; weight less than 250 lbs; and able to walk for 10 continuous minutes independently. Inclusion criteria for participants with PD also include: diagnosis of idiopathic, typical Parkinson disease according to the United Kingdom Brain Bank Criteria; Hoehn & Yahr stages 2-3 (mild to moderate disease severity); stable on all PD medications for at least 2 months prior to study entry; a score of 1 or less on item # 7 on the New Freezing of Gait Questionnaire; and score of ≥ 1 on the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III Item #10 indicating observable gait impairment. Exclusion Criteria for both groups include: diagnosis of any other neurological condition; significant cognitive impairment; 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); contraindications for magnetic resonance imaging (e.g., metallic implants); or uncontrolled tremor or dyskinesia (while on PD medications if applicable).
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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