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

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ClinicalTrials.gov Identifier: NCT02925065
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Non-traditional group guitar instruction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : July 26, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Upper extremity motor function [ Time Frame: 6 weeks and 12 weeks follow up ]
    Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  3. 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.

  4. 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.

  5. 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. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925065


Locations
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United States, Maryland
Johns Hopkins University (Peabody Institute & Department of Neurology)
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Serap E Bastepe-Gray, MD, MM, MsOT Johns Hopkins University
Principal Investigator: Alexander Pantelyat, MD Johns Hopkins University
Publications:
Hartigan, B. J., & Sarrafian, S. K. (2004). Kinesiology and functional characteristics of upper limb. In D. G. Smith, J. W. Michael, & J. H. Bowker (Eds.), Atlas of amputations and limb deficiencies: surgical, prosthetic, and rehabilitation principles (3rd Edition ed., pp. 101-116). Rosemont, IL: American Academy of Orthopaedic Surgeons.
Sheikh J.I., & Yesavage J.A. (1986): Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. In: Brink TL, editor. Clinical Gerontology: A Guide to Assessment and Intervention. Binghampton,NY: The Haworth Press. 165-173.
Richard K Miller and Associates. (2012). The 2012-2013 Leisure Market Research Handbook. Loganville, GA: Richard K. Miller and Associates.

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02925065    
Other Study ID Numbers: IRB00091797
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Parkinson's
Non-traditional guitar instruction
Guitar therapy
Upper extremity motor function
Hand dexterity
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases