Feasibility of Whole-body Drumming Classes for People With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- A.T. Still University Arizona School of Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Group
Arm Description
A single group of subjects with pretest, posttest, and one-month follow-up testing relative to 10-week drumming exercise classes
Outcomes
Primary Outcome Measures
Step Cadence Variability
Variability (SD) of step cadence
Step Cadence Variability
Variability (SD) of step cadence
Step Cadence Variability
Variability (SD) of step cadence
Stride Length Variability
Variability (SD) of stride length
Stride Length Variability
Variability (SD) of stride length
Stride Length Variability
Variability (SD) of stride length
Change in repeated finger-tapping
change in inter-tapping intervals (ms) change from pre- to post-intervention
Change in repeated finger-tapping
change in inter-tapping intervals (ms) change from pre- to 1-month following end of intervention
Secondary Outcome Measures
Change in Nine-hole peg test (NHP) duration (s)
change in speed of manual dexterity (s on NHP) from pre- to post-intervention
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
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.
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
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
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
Geriatric Depression Scale (GDS)
change in depression (GDS score; 0-15, higher is worse with more depression) from pre- to post-intervention
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
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
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
Lille Apathy Rating Scale (LARS)
change in apathy (LARS score; -36 to +36, lower is better with less apathy) from pre- to post-intervention
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
Full Information
NCT ID
NCT04982003
First Posted
May 18, 2021
Last Updated
January 30, 2023
Sponsor
A.T. Still University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04982003
Brief Title
Feasibility of Whole-body Drumming Classes for People With Parkinson's Disease
Official Title
Feasibility and Effects of Whole-body Drumming Classes on Walking in People With Parkinson's Disease: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
A.T. Still University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group, pre- post-test design
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Group
Arm Type
Experimental
Arm Description
A single group of subjects with pretest, posttest, and one-month follow-up testing relative to 10-week drumming exercise classes
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
10 weekly hour-long classes of drumming to music using large-amplitude, whole-body movements
Primary Outcome Measure Information:
Title
Step Cadence Variability
Description
Variability (SD) of step cadence
Time Frame
within 7 days before the intervention
Title
Step Cadence Variability
Description
Variability (SD) of step cadence
Time Frame
within 7 days after intervention
Title
Step Cadence Variability
Description
Variability (SD) of step cadence
Time Frame
1-month following intervention
Title
Stride Length Variability
Description
Variability (SD) of stride length
Time Frame
within 7 days before the intervention
Title
Stride Length Variability
Description
Variability (SD) of stride length
Time Frame
within 7 days after intervention
Title
Stride Length Variability
Description
Variability (SD) of stride length
Time Frame
1-month following intervention
Title
Change in repeated finger-tapping
Description
change in inter-tapping intervals (ms) change from pre- to post-intervention
Time Frame
within 7 days before the intervention and within 7 days after intervention
Title
Change in repeated finger-tapping
Description
change in inter-tapping intervals (ms) change from pre- to 1-month following end of intervention
Time Frame
within 7 days before the intervention and 1-month following end of intervention
Secondary Outcome Measure Information:
Title
Change in Nine-hole peg test (NHP) duration (s)
Description
change in speed of manual dexterity (s on NHP) from pre- to post-intervention
Time Frame
within 7 days before the intervention and within 7 days after intervention
Title
Change in Nine-hole peg test (NHP) duration (s)
Description
change in speed of manual dexterity (s on NHP) from pre- to 1-month following end of intervention
Time Frame
within 7 days before the intervention, and 1-month following intervention
Title
Change in Physical Performance Test (PPT) score
Description
change in whole-body functional mobility (PPT score; 0-36; higher is better) from pre- to post-intervention.
Time Frame
within 7 days before the intervention and within 7 days after intervention
Title
Change in Physical Performance Test (PPT) score
Description
change in whole-body functional mobility (PPT score; 0-36; higher is better) from pre- to 1-month following end of intervention
Time Frame
within 7 days before the intervention, and 1-month following intervention
Title
Change in Parkinson Disease Questionnaire (PDQ-39)
Description
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
Time Frame
within 7 days before the intervention and within 7 days after intervention
Title
Change in Parkinson Disease Questionnaire (PDQ-39)
Description
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
Time Frame
within 7 days before the intervention, and 1-month following intervention
Title
Geriatric Depression Scale (GDS)
Description
change in depression (GDS score; 0-15, higher is worse with more depression) from pre- to post-intervention
Time Frame
within 7 days before the intervention and within 7 days after intervention
Title
Geriatric Depression Scale (GDS)
Description
change in depression (GDS score; 0-15, higher is worse with more depression) from pre- to 1-month following end of intervention
Time Frame
within 7 days before the intervention, and 1-month following intervention
Title
General Self-Efficacy scale (GSE)
Description
change in self-efficacy (GSE score; 10-40, higher is better with more self-efficacy) from pre- to post-intervention
Time Frame
within 7 days before the intervention and within 7 days after intervention
Title
General Self-Efficacy scale (GSE)
Description
change in self-efficacy (GSE score; 10-40, higher is better with more self-efficacy) from pre- to 1-month following end of intervention
Time Frame
within 7 days before the intervention, and 1-month following intervention
Title
Lille Apathy Rating Scale (LARS)
Description
change in apathy (LARS score; -36 to +36, lower is better with less apathy) from pre- to post-intervention
Time Frame
within 7 days before the intervention and within 7 days after intervention
Title
Lille Apathy Rating Scale (LARS)
Description
change in apathy (LARS score; -36 to +36, lower is better with less apathy) from pre- to 1-month following end of intervention
Time Frame
within 7 days before the intervention, and 1-month following intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara L McIsaac, PhD, PT
Organizational Affiliation
A.T. Still University
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.T. Still University Arizona School of Health Sciences
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Whole-body Drumming Classes for People With Parkinson's Disease
We'll reach out to this number within 24 hrs