Efficacy of a Combined Linguistic/Communication Therapy in Acute Aphasia After Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study

Conditions
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Aphasia, Acquired

Intervention / Treatment
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* Other: Combined rehabilitation
* Other: Linguistic rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two arms in the protocol: one experimental arm corresponding to the combined rehabilitation (linguistic/communication) compared with another arm corresponding to the linguistic rehabilitation. All included patients, after allocation based on aphasia severity to the  combined  and  linguistic  groups, will have a first evaluation (E1: language, neurologic and neuropsychological exams) within 7 days after the onset. Then after a 3 months rehabilitation period they will be assessed (E2: language, neurologic and neuropsychological exams). At 6 months after the onset they will finally have the last assessment (E3: language, neurologic and neuropsychological exams).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined rehabilitation<br>Linguistic training as well as communication training. | Other: Combined rehabilitation<br>* Linguistic training as well as communication training.<br>|
| Active Comparator: Linguistic rehabilitation<br>Rehabilitation only focused on linguistic processes. | Other: Linguistic rehabilitation<br>* Rehabilitation only focused on linguistic processes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the communication performance. | Assessed by the Lillois communication test | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the communication performance. | Assessed by the Lillois communication test | Month 6 | 
| Assessment of the linguistic performance. | Assessed by the Score at understanding task. | Month 3; Month 6 | 
| Assessment of the quality of life. | Assessed by the Score at a specific quality of life scale . | Month 3; Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aphasia, Rehabilitation, Communication, Linguistics