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

Aphasia, Acquired Clinical Trial

— ORACLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287544
• Other study ID #: RC31/16/0018
• Secondary ID: 2017-A02163-50
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 27, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 27, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Acquired

Intervention

Other:
• Combined rehabilitation
Linguistic training as well as communication training.
• Linguistic rehabilitation
Rehabilitation only focused on linguistic processes.

Locations

Country	Name	City	State
France	Hôpital Pierre Paul Riquet	Toulouse	Midi-Pyrénées

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the communication performance.	Assessed by the Lillois communication test	Month 3
Secondary	Assessment of the communication performance.	Assessed by the Lillois communication test	Month 6
Secondary	Assessment of the linguistic performance.	Assessed by the "Score at understanding task".	Month 3; Month 6
Secondary	Assessment of the quality of life.	Assessed by the "Score at a specific quality of life scale ".	Month 3; Month 6