SFYS: Sing for Your Saunter

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04246476
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
60
1
2
41.7
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mentally singing
  • Behavioral: Listening to music
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Sing for Your Saunter: Using Self-generated Rhythmic Cues to Enhance Gait in Parkinson's
Actual Study Start Date :
Mar 9, 2020
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Self cueing

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

Behavioral: Mentally singing
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.

Behavioral: Listening to music
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).

Behavioral: Mentally singing
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.

Behavioral: Listening to music
All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat.

Outcome Measures

Primary Outcome Measures

  1. Stride Time Variability [Baseline]

    Measured with wearable sensors by APDM Wearable Technology

  2. Gait Speed [Baseline]

    Measured with wearable sensors by APDM Wearable Technology

Secondary Outcome Measures

  1. Blood Oxygen Level Dependent Signal (BOLD) during movement [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.

  2. Blood Oxygen Level Dependent Signal (BOLD) when listening to music vs. mentally singing [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Program in Physical Therapy Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gammon M Earhart, Director, Program in Physical Therapy, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT04246476
Other Study ID Numbers:
  • 201908117
  • 1R61AT010753-01
First Posted:
Jan 29, 2020
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gammon M Earhart, Director, Program in Physical Therapy, Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022