Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients (PD/Guitar)

September 28, 2018 updated by: Johns Hopkins University
This controlled prospective cohort study is designed to assess the feasibility and effect of twice-weekly 60 minute non-traditional guitar classes on PD patient's self-reported and measurable outcomes including upper extremity function, motor findings, quality of life, mood, and cognitive findings. 24-30 individuals with PD will be randomly assigned to an early-start and a late-start guitar instruction group. Prior to conducting a larger study, this study seeks to assess the possibility that participation in an instrumental performance activity in a group setting may improve outcomes in PD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PROBLEM STATEMENT: Engagement in musical activities has been found to improve symptoms in individuals with Parkinson's disease (PD), and physical therapy and music therapy have been demonstrated as viable non-pharmacological intervention methods that improve motor function in these individuals. Therapeutic instrumental music performance has the attributes of physical, rhythmic and social engagement combined with immediate auditory feedback, and has the potential to bring in additional neuro-rehabilitative effects associated with musical engagement into a treatment design. However, until now, much of the research has focused on the rhythmic aspects of music. Few studies have examined how active and complex engagement with music, such as learning to play an instrument, may help PD patients. Finger-style guitar instruction has the potential to improve bilateral dexterity in addition to other gains reported with music-based interventions in patients with PD.

PURPOSE: The purpose of this pilot controlled prospective cohort study is to assess the feasibility and the effects of non-traditional finger-style guitar classes on the quality of life, motor symptoms, upper extremity function, cognition, mood and social participation in individuals with PD.

HYPOTHESIS: The investigators hypothesize that a 6-week bi-weekly finger-style guitar group intervention (12 sessions in total) in addition to usual and routine treatment will be a feasible intervention in patients with Parkinson's Disease (PD), and both immediate and delayed start groups, of PD patients who participate in a twice-weekly non-traditional guitar class training for 6 weeks will have unchanged or improved upper extremity function and dexterity, improved quality of life and mood.

IMPORTANCE: The estimated overall prevalence of PD in the world is 315 per 100,000 individuals overall, and about 2 per 100 individuals 60 years of age or older, with higher estimates for older individuals living in North America, Europe and Australia. PD prevalence in the United States is projected to rise by 77% between 2010 and 2030. Music and rhythm-based interventions are noninvasive, patient-oriented techniques that lack side effects. The guitar is the most popular played instrument in the U.S, and it is the principal instrument of choice for music therapists. It is affordable and portable, with easy access to commercial instruction. Non-traditional engagement in finger-style music making on the guitar may have a broad impact on PD by improving the quality of functional upper extremity movements, decreasing the amplitude of involuntary movements, increasing social and cognitive participation in activities of daily living, and improving quality of life.

Study Type

Interventional

Enrollment (Actual)

26

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Johns Hopkins University (Peabody Institute & Department of Neurology)

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

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (age 18-89) with idiopathic PD diagnosis according to the United Kingdom (UK) Brain Bank Criteria with bilateral motor symptoms.
  • Hoehn and Yahr Stages 1-3.
  • MoCA score >24 to screen out patients with dementia.

Exclusion Criteria:

  • Prior exposure to guitar training.
  • History of prior trauma of the brain or upper extremities.
  • Inability to personally consent to study.
  • Inability or unwillingness to participate in twice weekly classes for 6 weeks.
  • Agitation or hallucinations.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early-start guitar instruction group
A 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 1-6 of the study.
Other: Non-traditional group guitar instruction
A 6-week curriculum for non-traditional training in finger-style guitar has been developed with rhythmic and goal oriented upper extremity and finger movements. Guitar group intervention will be implemented at the Towson campus of the Peabody Preparatory. Intervention approaches will include rhythmic digital grip with finger isolation, goal directed rhythmic reach on the fret-board and rhythmic alternating tap-like digit and hand movements on the guitar. Participants will be provided with the instruments in the group setting without expectation of practice at home.
EXPERIMENTAL: Delayed-start guitar instruction group
A 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 8-13 of the study.
Other: Non-traditional group guitar instruction
A 6-week curriculum for non-traditional training in finger-style guitar has been developed with rhythmic and goal oriented upper extremity and finger movements. Guitar group intervention will be implemented at the Towson campus of the Peabody Preparatory. Intervention approaches will include rhythmic digital grip with finger isolation, goal directed rhythmic reach on the fret-board and rhythmic alternating tap-like digit and hand movements on the guitar. Participants will be provided with the instruments in the group setting without expectation of practice at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 6 weeks
Percentage of study completion will be used to assess feasibility of the intervention along with descriptive statistics. The study will be deemed feasible if 80% of participants complete 10 or more guitar group interventions. The factors that affect probability of attending guitar classes will also be investigated.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Quality of Life
Time Frame: 6 weeks and 12 week follow up
The Parkinson disease quality of life assessment (PDQ-39) (Peto, Jenkinson & Fitzpatrick, 1998) is a questionnaire that is designed to assess PD specific health related quality of life within the last month in individuals with PD. Dimensions covered include mobility, activities of daily living, emotional well-being, stigma and social support, cognition, communication and bodily support.
6 weeks and 12 week follow up
Upper extremity motor function
Time Frame: 6 weeks and 12 weeks follow up
Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
6 weeks and 12 weeks follow up
Fine manual dexterity
Time Frame: 6 weeks and 12 weeks follow up
Purdue pegboard test (PPBT) involves timed assembly of small items and assesses fine manual dexterity.
6 weeks and 12 weeks follow up
Gross manual dexterity
Time Frame: 6 weeks and 12 weeks follow up
Box and block test (BBT) involves timed transfer of 2.5cm3 blocks from one container to another and assesses the gross manual dexterity.
6 weeks and 12 weeks follow up
Upper extremity activities of daily living function
Time Frame: 6 weeks and 12 weeks follow up
Quick-Disability of Arm, Shoulder and Hand (Q-DASH) (Gummeson, Ward & Atroshi, 2006) is an 11-item questionnaire that measures the self-reported disability of upper extremity.
6 weeks and 12 weeks follow up
Upper extremity finger typing accuracy and speed
Time Frame: 6 weeks and 12 weeks follow up
Finger typing task: Using index and middle finger to press 2 adjacent standard keyboard keys ('n' and 'm' for the right hand; 'c' and 'v' for the left hand) in alternating fashion as rapidly and accurately as possible in 60 seconds (each hand tested separately).
6 weeks and 12 weeks follow up
Cognition
Time Frame: 6 weeks and 12 week follow up
Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) is a rapid cognitive screening test that assesses cognitive performance in multiple domains including visuo-spatial and executive functions, naming, memory, attention, language, abstraction, and orientation.
6 weeks and 12 week follow up
Mood
Time Frame: 6 weeks and 12 week follow up
Geriatric Depression Scale (GD S-15) (Sheikh & Yesavage, 1986) is a 15 item questionnaire that assesses depression and suicide ideation in elderly individuals.
6 weeks and 12 week follow up
Social Participation
Time Frame: 6 weeks and 12 weeks follow up
World Health Organization Disability Assessment Schedule (WHODAS 2.0) Social participation subscale. WHODAS 2.0 is a 36 item disability assessment questionnaire developed by the WHO Classification, Terminology and Standards team to measure health and disability. The social participation subscale (Domain 6) contains 8 items and measures impact of health on social participation.
6 weeks and 12 weeks follow up
Group participation
Time Frame: 6 weeks and 12 weeks follow up
Pittsburg Rehabilitation Participation Scale (PRPS) will be used to monitor participation intensity and quality of the participants in the guitar group intervention.
6 weeks and 12 weeks follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Serap E Bastepe-Gray, MD, MM, MsOT, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 5, 2018

Primary Completion (ACTUAL)

June 7, 2018

Study Completion (ACTUAL)

July 26, 2018

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (ESTIMATE)

October 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00091797

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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