Sing for Your Saunter

NCT04246476 | Completed Results DMC

• 2 other identifiers: 2019081171R61AT010753-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

parkinson disease; music; imaging; mental singing; gait

Outcome Measures

Primary Outcomes (2)

• Gait Speed

  Measured with wearable sensors by APDM Wearable Technology

  Baseline

• Stride Length Variability

  Measured with wearable sensors by APDM Wearable Technology

  Baseline

Secondary Outcomes (1)

• Brain Activity (BOLD Signal)

  Baseline

Study Arms (2)

Self cueing

EXPERIMENTAL

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

Behavioral: Mentally singing; Behavioral: Listening to music

External cueing

ACTIVE COMPARATOR

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

Behavioral: Mentally singing; Behavioral: Listening to music

Interventions

Mentally singing BEHAVIORAL

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.

External cueing; Self cueing

Listening to music BEHAVIORAL

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

External cueing; Self cueing

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Washington University School of Medicine Program in Physical Therapy

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Gammon Earhart
• Organization: Washington University in St. LOuis

earhartg@wustl.edu

3142861407

Study Officials

• Gammon Earhart

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Program in Physical Therapy

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 29, 2020
• Study Start: March 9, 2020
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: July 1, 2025
• Results First Posted: May 16, 2024

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)