Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients
PD/Guitar
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2018
CompletedOctober 2, 2018
September 1, 2018
3 months
October 4, 2016
September 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Secondary Outcomes (10)
Efficacy: Quality of Life
6 weeks and 12 week follow up
Upper extremity motor function
6 weeks and 12 weeks follow up
Fine manual dexterity
6 weeks and 12 weeks follow up
Gross manual dexterity
6 weeks and 12 weeks follow up
Upper extremity activities of daily living function
6 weeks and 12 weeks follow up
- +5 more secondary outcomes
Study Arms (2)
Early-start guitar instruction group
EXPERIMENTALA 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 1-6 of the study.
Delayed-start guitar instruction group
EXPERIMENTALA 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 8-13 of the study.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins University (Peabody Institute & Department of Neurology)
Baltimore, Maryland, 21202, United States
Related Publications (23)
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BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Serap E Bastepe-Gray, MD, MM, MsOT
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Alexander Pantelyat, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 5, 2016
Study Start
March 5, 2018
Primary Completion
June 7, 2018
Study Completion
July 26, 2018
Last Updated
October 2, 2018
Record last verified: 2018-09