Sing for Your Saunter (SFYS)

June 14, 2023 updated by: Gammon M Earhart, Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine Program in Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self cueing
People living with Parkinson disease and controls walking with self-generated rhythmic cues.
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.
All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat.
Active Comparator: External cueing
People living with Parkinson disease and controls walking to external rhythmic cues (i.e., music).
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.
All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping 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
Gait Speed
Time Frame: Baseline
Measured with wearable sensors by APDM Wearable Technology
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Oxygen Level Dependent Signal (BOLD) during movement
Time Frame: Baseline
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.
Baseline
Blood Oxygen Level Dependent Signal (BOLD) when listening to music vs. mentally singing
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gammon Earhart, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Actual)

January 20, 2023

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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