- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04982003
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
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Single Group
A single group of subjects with pretest, posttest, and one-month follow-up testing relative to 10-week drumming exercise classes
|
10 weekly hour-long classes of drumming to music using large-amplitude, whole-body movements
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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)
February 22, 2019
Primary Completion (Anticipated)
July 30, 2022
Study Completion (Anticipated)
July 30, 2022
Study Registration Dates
First Submitted
May 18, 2021
First Submitted That Met QC Criteria
July 19, 2021
First Posted (Actual)
July 29, 2021
Study Record Updates
Last Update Posted (Actual)
January 27, 2022
Last Update Submitted That Met QC Criteria
January 26, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Parkinson Disease
-
Bezmialem Vakif UniversityRecruitingParkinson Disease | Parkinson | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseTurkey (Türkiye)
-
CND Life SciencesDigestive Disease Associates of CTRecruitingParkinson Disease | Parkinson | PARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Neuron23 Inc.Roche Diagnostic Ltd.; Qiagen Manchester LimitedRecruitingParkinson Disease | Parkinson | Idiopathic Parkinson Disease | Parkinson Disease, Idiopathic | Early Parkinson Disease (Early PD)United States, Spain, Israel, Poland, Italy, United Kingdom
-
San Francisco Neurology and Sleep CenterNot yet recruitingPARKINSON DISEASE (Disorder) | Parkinson s DiseaseUnited States
-
Haukeland University HospitalUniversity of Bergen; SPARK NSRecruitingParkinson Disease (PD) | Parkinson s DiseaseNorway
-
Bezmialem Vakif UniversityIstanbul University - CerrahpasaNot yet recruitingParkinson Disease | PARKINSON DISEASE (Disorder) | Parkinson Disease (PD), Postural Balance
-
CND Life SciencesOregon Health and Science UniversityRecruitingParkinson Disease | Parkinson | Parkinson's Disease and Parkinsonism | PARKINSON DISEASE (Disorder)United States
-
Università degli Studi dell'InsubriaUniversidade Nova de Lisboa; Associazione Parkinson Insubria (AsPI), Section... and other collaboratorsRecruitingParkinson Disease | Parkinson | Parkinson Disease, Idiopathic | PARKINSON DISEASE (Disorder)Italy
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
Duke UniversityMedical University of South Carolina; Massachusetts General Hospital; Mayo Clinic and other collaboratorsNot yet recruitingGut Microbiota | Gut Microbiome | Parkinson Disease (PD) | PARKINSON DISEASE (Disorder) | Prodromal Parkinsons DiseaseUnited States
Clinical Trials on exercise
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Aksaray University Training and Research HospitalCompletedExercise Training | Lactate Blood Increase | Cognitive Functions | BDNFTurkey (Türkiye)
-
Bayero University Kano, NigeriaCompletedChronic Low Back PainNigeria
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of Alabama at BirminghamCompletedCystic FibrosisUnited States
-
Center for Health, Exercise and Sport Sciences,...CompletedSedentary LifestyleSerbia
-
Heitor Moreno JuniorUnknown
-
Middle East Technical UniversityCompletedOsteoarthritis | Degenerative Lesion of Articular Cartilage of Knee | Articular Cartilage Disorder of KneeTurkey
-
University of LisbonFundação para a Ciência e a TecnologiaActive, not recruiting