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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03287544
Acronym
ORACLE
Enrollment
19
Registered
2017-09-19
Start date
2018-03-01
Completion date
2023-12-27
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Acquired

Keywords

Aphasia, Rehabilitation, Communication, Linguistics

Brief summary

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

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.

Interventions

Linguistic training as well as communication training.

OTHERLinguistic rehabilitation

Rehabilitation only focused on linguistic processes.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the communication performance.Month 3Assessed by the Lillois communication test

Secondary

MeasureTime frameDescription
Assessment of the communication performance.Month 6Assessed by the Lillois communication test
Assessment of the linguistic performance.Month 3; Month 6Assessed by the Score at understanding task.
Assessment of the quality of life.Month 3; Month 6Assessed by the Score at a specific quality of life scale .

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026