Feasibility of Whole-body Drumming Classes for People With Parkinson's Disease

January 26, 2022 updated by: Tara McIsaac, A.T. Still University of Health Sciences

Feasibility and Effects of Whole-body Drumming Classes on Walking in People With Parkinson's Disease: a Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • A.T. Still University Arizona School of Health Sciences

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Group
A single group of subjects with pretest, posttest, and one-month follow-up testing relative to 10-week drumming exercise classes
Other: exercise
10 weekly hour-long classes of drumming to music using large-amplitude, whole-body movements

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Step Cadence Variability
Time Frame: within 7 days before the intervention
Variability (SD) of step cadence
within 7 days before the intervention
Step Cadence Variability
Time Frame: within 7 days after intervention
Variability (SD) of step cadence
within 7 days after intervention
Step Cadence Variability
Time Frame: 1-month following intervention
Variability (SD) of step cadence
1-month following intervention
Stride Length Variability
Time Frame: within 7 days before the intervention
Variability (SD) of stride length
within 7 days before the intervention
Stride Length Variability
Time Frame: within 7 days after intervention
Variability (SD) of stride length
within 7 days after intervention
Stride Length Variability
Time Frame: 1-month following intervention
Variability (SD) of stride length
1-month following intervention
Change in repeated finger-tapping
Time Frame: within 7 days before the intervention and within 7 days after intervention
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
Time Frame: within 7 days before the intervention and 1-month following end of intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Nine-hole peg test (NHP) duration (s)
Time Frame: within 7 days before the intervention and within 7 days after intervention
change in speed of manual dexterity (s on NHP) from pre- to post-intervention
within 7 days before the intervention and within 7 days after intervention
Change in Nine-hole peg test (NHP) duration (s)
Time Frame: within 7 days before the intervention, and 1-month following intervention
change in speed of manual dexterity (s on NHP) from pre- to 1-month following end of intervention
within 7 days before the intervention, and 1-month following intervention
Change in Physical Performance Test (PPT) score
Time Frame: within 7 days before the intervention and within 7 days after intervention
change in whole-body functional mobility (PPT score; 0-36; higher is better) from pre- to post-intervention.
within 7 days before the intervention and within 7 days after intervention
Change in Physical Performance Test (PPT) score
Time Frame: within 7 days before the intervention, and 1-month following intervention
change in whole-body functional mobility (PPT score; 0-36; higher is better) from pre- to 1-month following end of intervention
within 7 days before the intervention, and 1-month following intervention
Change in Parkinson Disease Questionnaire (PDQ-39)
Time Frame: within 7 days before the intervention and within 7 days after intervention
change in disease-related quality of life (PDQ-39 score; 0-100, lower is better with improved quality of life) from pre- to post-intervention
within 7 days before the intervention and within 7 days after intervention
Change in Parkinson Disease Questionnaire (PDQ-39)
Time Frame: within 7 days before the intervention, and 1-month following intervention
change in disease-related quality of life (PDQ-39 score; 0-100, lower is better with improved quality of life) from pre- to 1-month following end of intervention
within 7 days before the intervention, and 1-month following intervention
Geriatric Depression Scale (GDS)
Time Frame: within 7 days before the intervention and within 7 days after intervention
change in depression (GDS score; 0-15, higher is worse with more depression) from pre- to post-intervention
within 7 days before the intervention and within 7 days after intervention
Geriatric Depression Scale (GDS)
Time Frame: within 7 days before the intervention, and 1-month following intervention
change in depression (GDS score; 0-15, higher is worse with more depression) from pre- to 1-month following end of intervention
within 7 days before the intervention, and 1-month following intervention
General Self-Efficacy scale (GSE)
Time Frame: within 7 days before the intervention and within 7 days after intervention
change in self-efficacy (GSE score; 10-40, higher is better with more self-efficacy) from pre- to post-intervention
within 7 days before the intervention and within 7 days after intervention
General Self-Efficacy scale (GSE)
Time Frame: within 7 days before the intervention, and 1-month following intervention
change in self-efficacy (GSE score; 10-40, higher is better with more self-efficacy) from pre- to 1-month following end of intervention
within 7 days before the intervention, and 1-month following intervention
Lille Apathy Rating Scale (LARS)
Time Frame: within 7 days before the intervention and within 7 days after intervention
change in apathy (LARS score; -36 to +36, lower is better with less apathy) from pre- to post-intervention
within 7 days before the intervention and within 7 days after intervention
Lille Apathy Rating Scale (LARS)
Time Frame: within 7 days before the intervention, and 1-month following intervention
change in apathy (LARS score; -36 to +36, lower is better with less apathy) from pre- to 1-month following end of intervention
within 7 days before the intervention, and 1-month following intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
A.T. Still University of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tara L McIsaac, PhD, PT, A.T. Still University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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