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临床试验/NCT03501797
NCT03501797已完成不适用

Efficacy of Choir Singing on Verbal, Cognitive, Emotional, and Neural Recovery From Aphasia

University of Helsinki2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月1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
100
试验地点
2
主要终点
Verbal agility

研究概览

简要总结

This study evaluates the verbal, cognitive, emotional, and neural efficacy of a choir singing intervention in chronic aphasic patients and their caregivers. Using a cross-over RCT design, half of the participants receive a 4-month singing intervention during the first half of the study and half of the participants during the second half of the study.

详细描述

BACKGROUND: Singing is a highly stimulating and versatile activity for the brain, combining vocal-motor, auditory, linguistic, cognitive, emotional, and social brain processes, both in the left and right hemisphere. The capacity to sing is often preserved in aphasia after stroke, and singing-based methods, such as Melodic Intonation Therapy (MIT), can be effective in rehabilitating speech production in aphasics. Also emotionally and socially, singing could provide a powerful alternative channel for aphasic patients to express their emotions and interact with others, but the communal or group-level use of singing in aphasia rehabilitation has not been systematically studied.

AIMS: The purpose of the study is to determine the clinical and neural efficacy of a novel choir singing intervention in subacute/chronic aphasia. Specifically, the targeted outcomes are (i) verbal and vocal-motor skills, (ii) cognitive skills, (iii) emotional functioning and quality of life, (iv) caregiver psychological well-being, and (v) structural and functional neuroplasticity. In addition, the capacity of singing and music learning in aphasia is explored.

METHODS: Subjects are 60 stroke patients with at least minor aphasia (≥ 6 months post-stroke) and their family members (FMs, N = 60) from Helsinki area recruited to a cross-over RCT study. Participants are randomized to two groups [N = 60 in both (30 patients, 30 FMs)], which receive a 16-week choir intervention either during the first (AB group) or second (BA group) half of the follow-up. The intervention is a combination of group training, which utilizes a novel combination of traditional senior choir singing and MIT-like speech training protocols, and home training in which the choir material is trained with a tablet computer. All patients are evaluated at baseline, 5-month, and 9-month stages with language, cognitive, and auditory-music tests and questionnaires. Half of the patients (N = 30) also undergo electroencephalography (EEG) and structural and functional magnetic resonance imaging (s/fMRI). FMs are evaluated with questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Verbal agility

时间窗: Change from baseline at 5 months and 9 months

Verbal Agility subtest score of the Boston Diagnostic Aphasia Examinaton (BDAE) (range 0-14, higher score indicates better outcome)

Verbal comprehension

时间窗: Change from baseline at 5 months and 9 months

Sequential Commands subtest score of the Western Aphasia Battery (WAB) (range 0-80, higher score indicates better outcome)

Connected speech informativeness

时间窗: Change from baseline at 5 months and 9 months

Percentage of correct information units (CIUs) produced in a picture description task

Communication ability

时间窗: Change from baseline at 5 months and 9 months

Total score of the Communication Action Log (CAL) questionnaire (range 0-180, higher score indicates better outcome)

Repetition of words and sentences

时间窗: Change from baseline at 5 months and 9 months

Repetition subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)

Spontaneous speech production

时间窗: Change from baseline at 5 months and 9 months

Spontaneous Speech subscale score of the Western Aphasia Battery (WAB) (range 0-20, higher score indicates better outcome)

Naming and word finding

时间窗: Change from baseline at 5 months and 9 months

Naming and Word Finding subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)

次要结局

  • Executive function (correct responses)(Change from baseline at 5 months and 9 months)
  • Attention (reaction times)(Change from baseline at 5 months and 9 months)
  • Verbal learning(Change from baseline at 5 months and 9 months)
  • Psychological stress of the caregiver(Change from baseline at 5 months and 9 months)
  • Electroencephalography (EEG)(Change from baseline at 5 months and 9 months)
  • Structural magnetic resonance imaging (sMRI): DTI sequence(Change from baseline at 5 months and 9 months)
  • Functional magnetic resonance imaging (fMRI): resting-state(Change from baseline at 5 months and 9 months)
  • Verbal memory(Change from baseline at 5 months and 9 months)
  • Music perception(Change from baseline at 5 months and 9 months)
  • Depression(Change from baseline at 5 months and 9 months)
  • Caregiver burden(Change from baseline at 5 months and 9 months)
  • Structural magnetic resonance imaging (sMRI): MPRAGE sequence(Change from baseline at 5 months and 9 months)
  • Functional magnetic resonance imaging (fMRI): singing-related activity(Change from baseline at 5 months and 9 months)
  • Executive function (reaction times)(Change from baseline at 5 months and 9 months)
  • Attention (correct responses)(Change from baseline at 5 months and 9 months)
  • Functional stroke recovery(Change from baseline at 5 months and 9 months)
  • Social interaction(Change from baseline at 5 months and 9 months)
  • Working memory(Change from baseline at 5 months and 9 months)
  • Singing ability(Change from baseline at 5 months and 9 months)
  • Mood(Change from baseline at 5 months and 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Teppo Sarkamo

Academy of Finland Research Fellow

University of Helsinki

研究点 (2)

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