跳至主要内容
临床试验/NCT07759375
NCT07759375尚未招募不适用

Combining Melodic Intonation Therapy and Constraint-Induced Aphasia Therapy for the Treatment of Non-fluent Aphasia: A Neuroplasticity-based Sequential Protocol for a Randomized Controlled Trial

Universidad de Granada0 个研究点目标入组 48 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
48
主要终点
Conversational speech

研究概览

简要总结

Sequentially applying Melodic Intonation Therapy (MIT) during the subacute phase, followed by Constraint-Induced Aphasia Therapy (CIAT) during the chronic phase

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 (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Have suffered a single LH stroke, with the RH remaining entirely intact;
  • Have a diagnosis of non-fluent aphasia characterized by non-fluent speech-with or without agrammatism, paraphasias, or stereotypies-anomia, and relatively preserved auditory comprehension;
  • Be within 9 weeks post-stroke at the time of enrollment;
  • Have no hearing, neurological, or psychiatric impairments;
  • Not be taking any medication that could affect language processing

排除标准

  • 未提供

研究组 & 干预措施

Experimental group

Experimental

CIPAN = MIT + CIAT

干预措施: CIPAN = MIT + CIAT (Behavioral)

Control group 1

Active Comparator

MIT + MIT

干预措施: MIT + MIT (Behavioral)

Control group 2

Active Comparator

CIAT + CIAT

干预措施: CIAT + CIAT (Behavioral)

结局指标

主要结局

Conversational speech

时间窗: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

From The Cookie Theft picture description of the Boston Diagnostic Aphasia Examination (BDAE)

Repetition

时间窗: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

From the Word and sentence repetition test of the Boston Diagnostic Aphasia Examination (BDAE)

Naming (auditory confrontation)

时间窗: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

From the Responsive naming test of the Boston Diagnostic Aphasia Examination (BDAE)

Naming (visual confrontation)

时间窗: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

From the Boston Naming Test of the Boston Diagnostic Aphasia Examination (BDAE)

Verbal fluency

时间窗: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

From the Verbal Fluency Test (VFT)

Functional communication

时间窗: At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225)

From the Communicative Activity Log (CAL)

次要结局

  • Neurofunctional activation(At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225))
  • Auditive comprehension(At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225))
  • Depression(At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225))
  • Lesion volume and extent(At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225))
  • White matter integrity(At baseline (day 63), after 1st therapeutic period (day 106), before 2nd therapeutic period (day 182) and after 2nd therapeutic period (day 225))

研究者

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

Antonio Bernal Benítez

Associate professor

Universidad de Granada

相似试验