- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05917704
Classical Guitar for Parkinson's Disease
CAPO: Classical Guitar to Alleviate Parkinson's Disease Symptom Onus
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher Adams, MS, MD
- Phone Number: 206-616-5207
- Email: caadams1@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Recruiting
- Northwest Chapter of the American Parkinson Disease Association
-
Contact:
- Christopher Adams, MS, MD
- Email: caadams1@uw.edu
-
Principal Investigator:
- Christopher Adams, MS, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Guitar then physical therapy
Subjects will learn classical guitar then have physical therapy sessions.
|
See arm/group descriptions
|
|
Active Comparator: Physical therapy then guitar
Subjects will have physical therapy sessions then learn classical guitar
|
See arm/group descriptions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the motor subscore of the Movement Disorder Society Unified Parkinson's Disease Rating Scale Motor Subscale
Time Frame: Baseline, 6 weeks, 12 weeks
|
Change in Parkinson's disease rating scale, range 0-32, higher score means more severe Parkinson's disease symptoms
|
Baseline, 6 weeks, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Parkinson's disease Questionnaire-39
Time Frame: Baseline, 6 weeks, 12 weeks
|
Change in scale for quality of life, range 0-100, higher means worse Parkinson's disease symptoms
|
Baseline, 6 weeks, 12 weeks
|
|
Change in percent of day with tremor
Time Frame: Baseline, 6 weeks, 12 weeks
|
Change in percent of day with tremor from apple watch
|
Baseline, 6 weeks, 12 weeks
|
|
Change in Beck Depression Inventory-II
Time Frame: Baseline, 6 weeks, 12 weeks
|
depression scale, range 0-63, higher score means worse depression
|
Baseline, 6 weeks, 12 weeks
|
|
Change in Apathy evaluation scale total score
Time Frame: Baseline, 6 weeks, 12 weeks
|
Change in apathy scale, range 18-72, higher scores means worse apathy
|
Baseline, 6 weeks, 12 weeks
|
|
Change in American Parkinson's disease Association symptom tracker score
Time Frame: Baseline, 6 weeks, 12 weeks
|
Change in Parkinson's disease symptom tracker, range 0-50, higher scores means worse symptoms
|
Baseline, 6 weeks, 12 weeks
|
|
Change in hours of sleep
Time Frame: Baseline, 6 weeks, 12 weeks
|
Change in hours of sleep measured from apple watch data
|
Baseline, 6 weeks, 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Adams, MS, MD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00017748
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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