Combining Anomia Therapy and Executive Function Training in Chronic Post-stroke Aphasia: a Pilot Study of Multidimensional Effects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 主要终点
- Change in repeated measures of naming scores
研究概览
简要总结
The goal of this clinical trial is to measure the effects of a speech therapy protocol combining anomia therapy and executive function training on naming and discourse in people with chronic aphasia, and to study the related brain changes.
The main questions it aims to answer are:
- Does the protocol improve naming skills ?
- Do the improvements observed transfer to discourse abilities ?
- Are there any brain changes induced by this protocol ?
Researchers will compare anomia therapy alone to anomia therapy + executive function training to see if the latter works better.
Participants will:
- Have a whole language assessment and a Magnetic Resonance Imaging (MRI) scan in the hospital before and after the protocol
- Receive 18 sessions of the protocol, 3 times a week during 6 weeks, in the hospital
- Have several naming assessments during the protocol
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18-80 years old) with post-stroke aphasia (> 6 months post-stroke)
- •Participant or legal representative able to understand the aims of the study
- •Participant or legal representative who have signed an informed consent form
排除标准
- •Aphasia with severe anarthria (mutism), comprehension disorders or alexia, incompatible with the purpose of the study
- •Contraindications for MRI
- •History of head trauma, brain tumor, neurodegenerative disease, or any other neurological or psychiatric condition
- •Non-affiliation to social welfare
结局指标
主要结局
Change in repeated measures of naming scores
时间窗: Every 2 or 3 sessions during the baseline phase (3 sessions per week during 3,5 to 5 weeks) and during the experimental phase (3 sessions per week during 6 weeks)
Naming skills will be repeatedly assessed for each participant every 2 or 3 sessions during the 3,5 to 5 weeks of the baseline phase (usual rehabilitation): 5 to 7 measures, and during the 6 weeks of the experimental phase: 6 to 9 measures. A naming task specifically designed for the study ("Deno 100"), including 100 black and white line drawing pictures will be used to this end. Scores will range from 0 (no item correctly named) to 100 (all items correctly named). A visual analysis (mean and trend) and statistical analyses will then be applied in order to measure the effect of the experimental treatment on treated words and the effect size.
次要结局
- Comparison of pre and post intervention control naming scores for each group (arm A / arm B) and between groups.(First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, 6 weeks after: just after the intervention, and 4 weeks after)
- Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Productivity (number of words produced / minute)(First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention)
- Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Lexical diversity (type-token ratio)(First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention)
- Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Syntactic structure (Predicate Argument Structure)(First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention)
- Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Efficience (Main Concept Analysis)(First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention)
- Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Informativity (% of correct information units)(First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention)
- MRI: Quantitative analyses(Before the baseline and just after the intervention: 9,5 to 11 weeks after)
- MRI: Qualitative analyses(Before the baseline and just after the intervention: 9,5 to 11 weeks after)