NCT04518917

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

November 1, 2024

Enrollment Period

2.1 years

First QC Date

August 15, 2020

Results QC Date

March 15, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

Parkinson diseaseMusicMental singingGait

Outcome Measures

Primary Outcomes (2)

  • Velocity

    Measured with wearable sensors by APDM Wearable Technology

    Baseline

  • Stride Length

    Measured with wearable sensors by APDM Wearable Technology

    Baseline

Study Arms (1)

Parkinson disease plus dementia

OTHER

Participants will have a diagnosis of Parkinson disease plus dementia.

Behavioral: Mentally SingingBehavioral: Listening to music

Interventions

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

Parkinson disease plus dementia

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

Parkinson disease plus dementia

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Gammon Earhart
Organization
Washington University in St. LOuis

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
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Program in Physical Therapy

Study Record Dates

First Submitted

August 15, 2020

First Posted

August 19, 2020

Study Start

April 19, 2021

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

January 9, 2025

Results First Posted

January 9, 2025

Record last verified: 2024-11

Locations