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Completed

NCT Number: NCT02925065

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

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University (Peabody Institute & Department of Neurology)

Baltimore, Maryland, 21202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-traditional group guitar instruction

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: PD/Guitar

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2016
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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