Adaptation of Melodic Intonation Therapy to Spanish: a Feasibility and Validation Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Boston Diagnostic Aphasia Examination
研究概览
简要总结
This study was conducted in three phases:
The first phase involved creation of a Spanish adaptation of the Melodic Intonation therapy; the second phase consisted of a pilot non-randomized intervention study to analyse its feasibility for use with 4 Spanish patients with poststroke nonfluent aphasia; the third phase consisted of a pilot randomised, crossover, intervention pilot trial in a different set of patients with poststroke nonfluent aphasia (N=20)
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)
盲法说明
A neuropsychologist blinded to the patients' clinical characteristics and the group to whom the patient was allocated evaluated outcome variables.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere who fulfilled the following criteria:
- •The time elapsed since the stroke exceeded 6 months.
- •Patient had received a standard program of conventional speech therapy after stroke.
- •Persistent nonfluent aphasia with the following characteristics:
- •Severely restricted language, which might be limited to meaningless stereotypy; unlike that observed in verbal tasks, the patient might produce some real and relevant words when singing familiar songs.
- •Poor repetition, even for single words.
- •Moderately preserved language comprehension.
- •The nonstereotyped language was produced with a slurring of speech.
- •The total score for the repetition did not exceed the 70th percentile in the Boston Diagnostic Aphasia Examination. The score was obtained from the average score in three areas: repetition of words and repetition of phrases; listening comprehension exceeding the 15th percentile of Boston Diagnostic Aphasia Examination; and from the average score obtained in three areas: word comprehension, commands and complex ideational material.
- •The patient was motivated, emotionally stable and had good attention.
- •Signed informed consent was provided.
排除标准
- •patients with a history of a previous stroke other than the index event or with any clinical condition (e.g., short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up in the study
- •patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery
- •use of psychotropic drugs that interfere with patient evaluation.
研究组 & 干预措施
Melodic Intonation Therapy
The duration of therapy was 12 sessions performed over a 6-week period. Each session lasted 30 minutes. They were performed individually by a speech-experienced therapist previously trained in Melodic Intonation Therapy.
干预措施: Melodic Intonation Therapy (Other)
Waiting list
No intervention
结局指标
主要结局
Boston Diagnostic Aphasia Examination
时间窗: 6 weeks after the end of therapy
Communicative Activity Log questionnaire
时间窗: 6 weeks after the end of therapy
次要结局
未报告次要终点