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临床试验/NCT02959736
NCT02959736Unknown不适用

Validating the Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC) Against the Best Practice External Reference Standard

Temple University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC)

研究概览

简要总结

The purpose of this project is to further develop a standardized music-based measure used in music therapy with adults who have emerged from coma following profound brain injury, but are not able to demonstrate responsiveness to their environment due to complex clinical needs. Building on previous work, the project aims to strengthen the psychometric properties (e.g. concurrent validity, responsiveness) of the measure for its use with adults with profound brain damage.

详细描述

Adult patients with prolonged disorders of consciousness (PDOC), but who have not been diagnosed as Minimally Conscious or Vegetative State, will be recruited. All participants will be assessed using the Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC) standardized protocol. Assessment intervention will take place in four individual clinical contacts, over a 16 day period. Data will be collected using the MATADOC rating form and scored according to the MATADOC manual. Participants will concurrently be assessed with Coma Recovery Scale-Revised (CRS-R).

The MATADOC is implemented by Music Therapists who have been trained in its use and who are experienced in working with adults with PDOC. CRS-R data will be collected by members of the treatment team who are experienced or trained in its use. MATADOC and CRS-R assessors will remain blinded to the data collected.

Analysis will compare diagnostic outcomes of the two measures as well as explore the function of comparable items of each measure across similar domains (e.g. auditory, visual).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medically stable patients (i.e. not currently suspected of or under investigation for infection)who have a prolonged disorder of consciousness i.e. has persisted for longer than 4 weeks
  • Between the ages of 18 and 70 years of age
  • A diagnosis of awareness (i.e., VS, MCS or emergent) is not confirmed or is under investigation
  • Fluent in English language comprehension as reported by the family

排除标准

  • Known pre-morbid hearing impairments
  • The patient has a previous diagnosis of musicogenic epilepsy
  • The patient had previously refused music therapy intervention
  • Patients with a suspected diagnosis of locked-in syndrome
  • Non-fluent in English comprehension as reported by family.

结局指标

主要结局

Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC)

时间窗: 16 days

Music based protocol

次要结局

  • Coma Recovery Scale - Revised (CRS-R)(16 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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