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Parkinson DiseaseNCT04982003

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

A study testing exercise in people with Parkinson Disease, run by A.T. Still University of Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
22 Feb 2019to 30 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • A.T. Still University Arizona School of Health Sciences

    Mesa, Arizona, 85206

Other trials in United States

About this study

Official title: 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.

Being tested
exercise
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exerciseOther

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

Study groups in NCT04982003
Study groupRoleWhat they receive
Single GroupExperimentalA single group of subjects with pretest, posttest, and one-month follow-up testing relative to 10-week drumming exercise classes
Receives: Other: exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Step Cadence Variability

    Variability (SD) of step cadence

    Measured: within 7 days before the intervention

  2. Step Cadence Variability

    Variability (SD) of step cadence

    Measured: within 7 days after intervention

  3. Step Cadence Variability

    Variability (SD) of step cadence

    Measured: 1-month following intervention

  4. Stride Length Variability

    Variability (SD) of stride length

    Measured: within 7 days before the intervention

  5. Stride Length Variability

    Variability (SD) of stride length

    Measured: within 7 days after intervention

  6. Stride Length Variability

    Variability (SD) of stride length

    Measured: 1-month following intervention

  7. Change in repeated finger-tapping

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

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

  8. Change in repeated finger-tapping

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

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

Secondary outcomes (12)

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

    change in speed of manual dexterity (s on NHP) from pre- to post-intervention

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

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

    change in speed of manual dexterity (s on NHP) from pre- to 1-month following end of intervention

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

  3. Change in Physical Performance Test (PPT) score

    change in whole-body functional mobility (PPT score; 0-36; higher is better) from pre- to post-intervention.

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

  4. Change in Physical Performance Test (PPT) score

    change in whole-body functional mobility (PPT score; 0-36; higher is better) from pre- to 1-month following end of intervention

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

  5. Change in Parkinson Disease Questionnaire (PDQ-39)

    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

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

  6. Change in Parkinson Disease Questionnaire (PDQ-39)

    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

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

  7. Geriatric Depression Scale (GDS)

    change in depression (GDS score; 0-15, higher is worse with more depression) from pre- to post-intervention

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

  8. Geriatric Depression Scale (GDS)

    change in depression (GDS score; 0-15, higher is worse with more depression) from pre- to 1-month following end of intervention

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

  9. General Self-Efficacy scale (GSE)

    change in self-efficacy (GSE score; 10-40, higher is better with more self-efficacy) from pre- to post-intervention

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

  10. General Self-Efficacy scale (GSE)

    change in self-efficacy (GSE score; 10-40, higher is better with more self-efficacy) from pre- to 1-month following end of intervention

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

  11. Lille Apathy Rating Scale (LARS)

    change in apathy (LARS score; -36 to +36, lower is better with less apathy) from pre- to post-intervention

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

  12. Lille Apathy Rating Scale (LARS)

    change in apathy (LARS score; -36 to +36, lower is better with less apathy) from pre- to 1-month following end of intervention

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start22 Feb 2019
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
single group, pre- post-test design
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04982003
Sponsor's protocol ID
2019-004
Status last verified
Jan 2023
First submitted
18 May 2021
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing exercise in people with Parkinson Disease, run by A.T. Still University of Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step Cadence Variability (time frame: within 7 days before the intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04982003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.

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