Clinical trial NCT02925065: Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients
Official title: Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's
Non-traditional guitar instruction
Guitar therapy
Upper extremity motor function
Hand dexterity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to early-start or late start guitar groups. Following baseline assessment week, the early-start group will receive twice-weekly non traditional guitar instruction for 6 weeks. The late-start guitar group will receive same intervention after the early-start group complete their 6 week instruction. Study assessments will be conducted during week 7 and week 14. Follow up assessment will be conducted in week 20.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility
timeFrame: 6 weeks
Secondary outcomes:
measure: Efficacy: Quality of Life
timeFrame: 6 weeks and 12 week follow up
measure: Upper extremity motor function
timeFrame: 6 weeks and 12 weeks follow up
measure: Fine manual dexterity
timeFrame: 6 weeks and 12 weeks follow up
measure: Gross manual dexterity
timeFrame: 6 weeks and 12 weeks follow up
measure: Upper extremity activities of daily living function
timeFrame: 6 weeks and 12 weeks follow up
measure: Upper extremity finger typing accuracy and speed
timeFrame: 6 weeks and 12 weeks follow up
measure: Cognition
timeFrame: 6 weeks and 12 week follow up
measure: Mood
timeFrame: 6 weeks and 12 week follow up
measure: Social Participation
timeFrame: 6 weeks and 12 weeks follow up
measure: Group participation
timeFrame: 6 weeks and 12 weeks follow up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (Peabody Institute & Department of Neurology)
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Serap E Bastepe-Gray, MD, MM, MsOT
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Alexander Pantelyat, MD
role: PRINCIPAL_INVESTIGATOR
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