NCT04982003

Brief Summary

People with Parkinson's disease (PD) experience difficulty with gait, postural instability, and lack of movement coordination and rhythmic timing. Non-motor functions affected by PD include time perception, feelings of apathy, depression, decreased self-efficacy, and decrease self-reported quality of life. There is currently a lack of information on how a therapeutic drumming class that uses whole-body large-amplitude movements to music would impact these motor and non-motor impairments in individuals with PD. The primary purpose of this study is to assess the feasibility of a 10-week whole-body drumming class to music specifically selected for its rhythmic structure, and effects on movement rhythm and time perception in individuals with PD. The secondary purpose is to assess the effects of the drumming class on apathy, depression, self-efficacy and health-related quality of life. Participants will be included if they have a diagnosis of PD and are able to move for an hour with rests, either standing or seated. Participants are tested before and after the class series and one month following.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2019

Longer than P75 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

Study Start

First participant enrolled

February 22, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

3.4 years

First QC Date

May 18, 2021

Last Update Submit

January 30, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • Step Cadence Variability

    Variability (SD) of step cadence

    within 7 days before the intervention

  • Step Cadence Variability

    Variability (SD) of step cadence

    within 7 days after intervention

  • Step Cadence Variability

    Variability (SD) of step cadence

    1-month following intervention

  • Stride Length Variability

    Variability (SD) of stride length

    within 7 days before the intervention

  • Stride Length Variability

    Variability (SD) of stride length

    within 7 days after intervention

  • Stride Length Variability

    Variability (SD) of stride length

    1-month following intervention

  • Change in repeated finger-tapping

    change in inter-tapping intervals (ms) change from pre- to post-intervention

    within 7 days before the intervention and within 7 days after intervention

  • Change in repeated finger-tapping

    change in inter-tapping intervals (ms) change from pre- to 1-month following end of intervention

    within 7 days before the intervention and 1-month following end of intervention

Secondary Outcomes (12)

  • Change in Nine-hole peg test (NHP) duration (s)

    within 7 days before the intervention and within 7 days after intervention

  • Change in Nine-hole peg test (NHP) duration (s)

    within 7 days before the intervention, and 1-month following intervention

  • Change in Physical Performance Test (PPT) score

    within 7 days before the intervention and within 7 days after intervention

  • Change in Physical Performance Test (PPT) score

    within 7 days before the intervention, and 1-month following intervention

  • Change in Parkinson Disease Questionnaire (PDQ-39)

    within 7 days before the intervention and within 7 days after intervention

  • +7 more secondary outcomes

Study Arms (1)

Single Group

EXPERIMENTAL

A single group of subjects with pretest, posttest, and one-month follow-up testing relative to 10-week drumming exercise classes

Other: exercise

Interventions

10 weekly hour-long classes of drumming to music using large-amplitude, whole-body movements

Single Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with PD
  • independent walking short community and household distances with or without assistive device
  • able to participate in a 1-hour class once a week for ten weeks

You may not qualify if:

  • change of Parkinson's medication or deep brain stimulation parameters within 2 weeks prior to or during the study
  • inability to grasp 2-inch diameter "drum sticks"
  • any conditions with contraindications to lift upper extremities overhead
  • any medical restrictions to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.T. Still University Arizona School of Health Sciences

Mesa, Arizona, 85206, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tara L McIsaac, PhD, PT

    A.T. Still University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single group, pre- post-test design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2021

First Posted

July 29, 2021

Study Start

February 22, 2019

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations