Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Assessment of the communication performance.
研究概览
简要总结
Linguistic training is traditionally the gold standard for rehabilitation of aphasia after stroke and efficacy criteria count early stage, intensity as well as personalized treatment. To date, no clear evidence showed a specific effect of any therapy in the acute phase of aphasia after stroke. This study aims to compare the effect of a combined therapy (linguistic/communication) versus a linguistic therapy on communication performance in patients in the acute phase of aphasia after a first stroke.
详细描述
Twenty to 25% of strokes cause aphasia. Speech and language therapy is the well-known standard treatment of aphasia after stroke although it is based on weak scientific evidence. To date, the efficacy criteria of aphasia rehabilitation are early stage, intensity as well as personalized treatment. Usually these patients receive in acute phase a linguistic training focused on the linguistic impairment. This approach is based on the cerebral plasticity postulate. However the superiority of this practice compared to other methods has never been shown. Moreover the benefit of the combination gathering linguistic treatment with communication treatment has to our knowledge never been studied.
In the present study investigators propose to compare the effect of a combined linguistic/communication rehabilitation versus a linguistic treatment. To do so, investigators will recruit patients with aphasia after a first stroke, in the acute phase. After a allocation to the " combined " and " linguistic " groups, all the patients will have a comprehensive language and neuropsychological assessment before and after 3 months of rehabilitation, and finally 6 months after the onset.
The "linguistic" group will have a rehabilitation only focused on linguistic processes whereas the "combined" group will have a linguistic training as well as communication training. The therapy will be personalized and the therapists will exclusively use standardized linguistic and/or communication toolboxes of rehabilitation containing dedicated activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
After the allocation in the groups, rehabilitation is not done blindly since the speech therapist knows what activities he offers to patients. However, the evaluations carried out by a speech therapist, are done without the knowledge of the rehabilitation group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First stroke
- •Inclusion at the acute phase (< 7 days)
- •Patient registered at the social security system
- •French as usual language
- •Aphasia severity score measured by the Boston Diagnostic Aphasia Examination (BDAE) scale ≥ 1 and ≤ 4
- •Consent signed by the patient or if not, by the caregiver
排除标准
- •Cognitive impairment before the onset (IQCode > 3.4)
- •Alcohol or drug addiction
- •Untreated psychiatric disease,
- •Uncorrected sensory impairment
- •Evolutive pathology
- •Adults protected by Law
- •Participation to another research
结局指标
主要结局
Assessment of the communication performance.
时间窗: Month 3
Assessed by the Lillois communication test
次要结局
- Assessment of the communication performance.(Month 6)
- Assessment of the quality of life.(Month 3; Month 6)
- Assessment of the linguistic performance.(Month 3; Month 6)