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

Toulouse University Hospital

Status: Completed

Conditions: Aphasia, Acquired

Treatments: Other: Linguistic rehabilitation; Other: Combined rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03287544

2017-A02163-50 (Other Identifier)

RC31/16/0018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Combined rehabilitation

Experimental group

Description:

Linguistic training as well as communication training.

Treatment:

Other: Combined rehabilitation

Linguistic rehabilitation

Active Comparator group

Description:

Rehabilitation only focused on linguistic processes.

Treatment:

Other: Linguistic rehabilitation