Classical Guitar for Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guitar then physical therapy
Physical therapy then guitar
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, music-based therapy
Eligibility Criteria
Inclusion Criteria: 50-90 years old Diagnosis with Parkinson's disease by a Movement Disorder specialist Exclusion Criteria: Professional musician or formal music training Inability to play a classical guitar physically Inability to follow instruction Receiving physical therapy at the time of the study Unable to attend all sessions of study
Sites / Locations
- Northwest Chapter of the American Parkinson Disease AssociationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Guitar then physical therapy
Physical therapy then guitar
Arm Description
Subjects will learn classical guitar then have physical therapy sessions.
Subjects will have physical therapy sessions then learn classical guitar
Outcomes
Primary Outcome Measures
Change in the motor subscore of the Movement Disorder Society Unified Parkinson's Disease Rating Scale Motor Subscale
Change in Parkinson's disease rating scale, range 0-32, higher score means more severe Parkinson's disease symptoms
Secondary Outcome Measures
Change in Parkinson's disease Questionnaire-39
Change in scale for quality of life, range 0-100, higher means worse Parkinson's disease symptoms
Change in percent of day with tremor
Change in percent of day with tremor from apple watch
Change in Beck Depression Inventory-II
depression scale, range 0-63, higher score means worse depression
Change in Apathy evaluation scale total score
Change in apathy scale, range 18-72, higher scores means worse apathy
Change in American Parkinson's disease Association symptom tracker score
Change in Parkinson's disease symptom tracker, range 0-50, higher scores means worse symptoms
Change in hours of sleep
Change in hours of sleep measured from apple watch data
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05917704
Brief Title
Classical Guitar for Parkinson's Disease
Official Title
CAPO: Classical Guitar to Alleviate Parkinson's Disease Symptom Onus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
December 12, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
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
The purpose of this study is to understand if training Parkinson's disease patients in classical guitar will improve motor function, mood, and quality of life. While medication has been found to be effective for many Parkinson's disease patients, many patients still have symptoms. Previous studies have found that music and rhythm-based activities can help Parkinson's disease symptoms. A previous study looked at the effect of playing classical guitar on Parkinson's disease symptoms. They found positive changes in Parkinson's disease symptoms that lasted for 6 weeks after the study ended. Further, there were positive changes in depression, anxiety, and quality of life.
Detailed Description
Subjects will be asked to take part in classical guitar lessons once a week for six weeks and physical therapy once a week for six weeks. There will be 40 people enrolled in the study. Twenty people will have classical guitar lessons first and physical therapy second. The other twenty people will have physical therapy first and classical guitar lessons second. The study will last a total of 12 weeks. Each session will last 1-2 hours. Sessions will be held at the Northwest Chapter headquarters of the American Parkinson's Disease Association.
Examples of the types of activities subjects will do during the physical therapy sessions include finger exercises, tasks with both hands, tasks while standing, and tasks while walking.
Examples of the types of activities you will do during the classical guitar lessons include playing chords and songs on the guitar.
Subjects will have physical exams and complete questionnaires at the beginning of the study, at six weeks, and at the end of the study.
If subjects have Apple watches, they will be asked to download an application called StrivePD on their watch and iPhone. StrivePD is an application that allows subjects to keep track of their Parkinson's disease symptoms or set medication reminders, for example. When used with an Apple watch, it can automatically record symptoms like tremors. During this study, the StrivePD application will only be used to collect data about what percentage of the day they have tremors and how much they sleep.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, music-based therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guitar then physical therapy
Arm Type
Active Comparator
Arm Description
Subjects will learn classical guitar then have physical therapy sessions.
Arm Title
Physical therapy then guitar
Arm Type
Active Comparator
Arm Description
Subjects will have physical therapy sessions then learn classical guitar
Intervention Type
Other
Intervention Name(s)
Guitar then physical therapy
Intervention Description
See arm/group descriptions
Intervention Type
Other
Intervention Name(s)
Physical therapy then guitar
Intervention Description
See arm/group descriptions
Primary Outcome Measure Information:
Title
Change in the motor subscore of the Movement Disorder Society Unified Parkinson's Disease Rating Scale Motor Subscale
Description
Change in Parkinson's disease rating scale, range 0-32, higher score means more severe Parkinson's disease symptoms
Time Frame
Baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Parkinson's disease Questionnaire-39
Description
Change in scale for quality of life, range 0-100, higher means worse Parkinson's disease symptoms
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in percent of day with tremor
Description
Change in percent of day with tremor from apple watch
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in Beck Depression Inventory-II
Description
depression scale, range 0-63, higher score means worse depression
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in Apathy evaluation scale total score
Description
Change in apathy scale, range 18-72, higher scores means worse apathy
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in American Parkinson's disease Association symptom tracker score
Description
Change in Parkinson's disease symptom tracker, range 0-50, higher scores means worse symptoms
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in hours of sleep
Description
Change in hours of sleep measured from apple watch data
Time Frame
Baseline, 6 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
50-90 years old
Diagnosis with Parkinson's disease by a Movement Disorder specialist
Exclusion Criteria:
Professional musician or formal music training
Inability to play a classical guitar physically
Inability to follow instruction
Receiving physical therapy at the time of the study
Unable to attend all sessions of study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Adams, MS, MD
Phone
206-616-5207
Email
caadams1@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Adams, MS, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Chapter of the American Parkinson Disease Association
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Adams, MS, MD
Email
caadams1@uw.edu
First Name & Middle Initial & Last Name & Degree
Christopher Adams, MS, MD
12. IPD Sharing Statement
Learn more about this trial
Classical Guitar for Parkinson's Disease
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