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临床试验/NCT02925065
NCT02925065已完成不适用

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

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Feasibility

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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-
  • MoCA score >24 to screen out patients with dementia.

排除标准

  • 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.

结局指标

主要结局

Feasibility

时间窗: 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.

次要结局

  • Gross manual dexterity(6 weeks and 12 weeks follow up)
  • Upper extremity activities of daily living function(6 weeks and 12 weeks follow up)
  • Upper extremity finger typing accuracy and speed(6 weeks and 12 weeks follow up)
  • Cognition(6 weeks and 12 week follow up)
  • Mood(6 weeks and 12 week follow up)
  • Group participation(6 weeks and 12 weeks follow up)
  • Upper extremity motor function(6 weeks and 12 weeks follow up)
  • Fine manual dexterity(6 weeks and 12 weeks follow up)
  • Social Participation(6 weeks and 12 weeks follow up)
  • Efficacy: Quality of Life(6 weeks and 12 week follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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