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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-traditional group guitar instruction
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's, Non-traditional guitar instruction, Guitar therapy, Upper extremity motor function, Hand dexterity

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins University (Peabody Institute & Department of Neurology)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early-start guitar instruction group

Delayed-start guitar instruction group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility
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

Efficacy: Quality of Life
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.
Upper extremity motor function
Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Fine manual dexterity
Purdue pegboard test (PPBT) involves timed assembly of small items and assesses fine manual dexterity.
Gross manual dexterity
Box and block test (BBT) involves timed transfer of 2.5cm3 blocks from one container to another and assesses the gross manual dexterity.
Upper extremity activities of daily living function
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.
Upper extremity finger typing accuracy and speed
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).
Cognition
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.
Mood
Geriatric Depression Scale (GD S-15) (Sheikh & Yesavage, 1986) is a 15 item questionnaire that assesses depression and suicide ideation in elderly individuals.
Social Participation
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.
Group participation
Pittsburg Rehabilitation Participation Scale (PRPS) will be used to monitor participation intensity and quality of the participants in the guitar group intervention.

Full Information

First Posted
October 4, 2016
Last Updated
September 28, 2018
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02925065
Brief Title
Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients
Acronym
PD/Guitar
Official Title
Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
June 7, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's, Non-traditional guitar instruction, Guitar therapy, Upper extremity motor function, Hand dexterity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early-start guitar instruction group
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed-start guitar instruction group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Non-traditional group guitar instruction
Intervention Description
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 Measure Information:
Title
Feasibility
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Efficacy: Quality of Life
Description
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.
Time Frame
6 weeks and 12 week follow up
Title
Upper extremity motor function
Description
Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame
6 weeks and 12 weeks follow up
Title
Fine manual dexterity
Description
Purdue pegboard test (PPBT) involves timed assembly of small items and assesses fine manual dexterity.
Time Frame
6 weeks and 12 weeks follow up
Title
Gross manual dexterity
Description
Box and block test (BBT) involves timed transfer of 2.5cm3 blocks from one container to another and assesses the gross manual dexterity.
Time Frame
6 weeks and 12 weeks follow up
Title
Upper extremity activities of daily living function
Description
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.
Time Frame
6 weeks and 12 weeks follow up
Title
Upper extremity finger typing accuracy and speed
Description
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).
Time Frame
6 weeks and 12 weeks follow up
Title
Cognition
Description
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.
Time Frame
6 weeks and 12 week follow up
Title
Mood
Description
Geriatric Depression Scale (GD S-15) (Sheikh & Yesavage, 1986) is a 15 item questionnaire that assesses depression and suicide ideation in elderly individuals.
Time Frame
6 weeks and 12 week follow up
Title
Social Participation
Description
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.
Time Frame
6 weeks and 12 weeks follow up
Title
Group participation
Description
Pittsburg Rehabilitation Participation Scale (PRPS) will be used to monitor participation intensity and quality of the participants in the guitar group intervention.
Time Frame
6 weeks and 12 weeks follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serap E Bastepe-Gray, MD, MM, MsOT
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Pantelyat, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University (Peabody Institute & Department of Neurology)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States

12. IPD Sharing Statement

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

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