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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05917704
Other study ID # STUDY00017748
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 6, 2023
Est. completion date February 1, 2024

Study information

Verified date June 2023
Source University of Washington
Contact Christopher Adams, MS, MD
Phone 206-616-5207
Email caadams1@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date February 1, 2024
Est. primary completion date December 12, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Guitar then physical therapy
See arm/group descriptions
Physical therapy then guitar
See arm/group descriptions

Locations

Country Name City State
United States Northwest Chapter of the American Parkinson Disease Association Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline, 6 weeks, 12 weeks
Secondary Change in Parkinson's disease Questionnaire-39 Change in scale for quality of life, range 0-100, higher means worse Parkinson's disease symptoms Baseline, 6 weeks, 12 weeks
Secondary Change in percent of day with tremor Change in percent of day with tremor from apple watch Baseline, 6 weeks, 12 weeks
Secondary Change in Beck Depression Inventory-II depression scale, range 0-63, higher score means worse depression Baseline, 6 weeks, 12 weeks
Secondary Change in Apathy evaluation scale total score Change in apathy scale, range 18-72, higher scores means worse apathy Baseline, 6 weeks, 12 weeks
Secondary 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 Baseline, 6 weeks, 12 weeks
Secondary Change in hours of sleep Change in hours of sleep measured from apple watch data Baseline, 6 weeks, 12 weeks
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