Clinical trial NCT03287544: Efficacy of a Combined Linguistic/Communication Therapy in Acute Aphasia After Stroke
Official title: Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia, Acquired
Keywords: Aphasia
Rehabilitation
Communication
Linguistics
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the communication performance.
timeFrame: Month 3
Secondary outcomes:
measure: Assessment of the communication performance.
timeFrame: Month 6
measure: Assessment of the linguistic performance.
timeFrame: Month 3; Month 6
measure: Assessment of the quality of life.
timeFrame: Month 3; Month 6
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet
state: Midi-Pyrénées
Study officials:
affiliation: University Hospital, Toulouse
name: Lola Danet, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galletta EE, Barrett AM. Impairment and Functional Interventions for Aphasia: Having it All. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):114-120. doi: 10.1007/s40141-014-0050-5.
citation: Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.
citation: Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042.
citation: Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22. doi: 10.1017/s0033291700005742.
citation: Behrmann M, Lieberthal T. Category-specific treatment of a lexical-semantic deficit: a single case study of global aphasia. Br J Disord Commun. 1989 Dec;24(3):281-99. doi: 10.3109/13682828909019892.
citation: Crosson B. An intention manipulation to change lateralization of word production in nonfluent aphasia: current status. Semin Speech Lang. 2008 Aug;29(3):188-200; quiz C-4. doi: 10.1055/s-0028-1082883.
citation: Jones EV. Building the foundations for sentence production in a non-fluent aphasic. Br J Disord Commun. 1986 Apr;21(1):63-82. doi: 10.3109/13682828609018544. No abstract available.