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

NCT03287544 | Completed

• 2 other identifiers: RC31/16/00182017-A02163-50
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia, Acquired

Keywords

Aphasia; Rehabilitation; Communication; Linguistics

Outcome Measures

Primary Outcomes (1)

• Assessment of the communication performance.

  Assessed by the Lillois communication test

  Month 3

Secondary Outcomes (3)

• Assessment of the communication performance.

  Month 6

• Assessment of the linguistic performance.

  Month 3; Month 6

• Assessment of the quality of life.

  Month 3; Month 6

Study Arms (2)

Combined rehabilitation

EXPERIMENTAL

Linguistic training as well as communication training.

Other: Combined rehabilitation

Linguistic rehabilitation

ACTIVE COMPARATOR

Rehabilitation only focused on linguistic processes.

Other: Linguistic rehabilitation

Interventions

Combined rehabilitation OTHER

Linguistic training as well as communication training.

Combined rehabilitation

Linguistic rehabilitation OTHER

Rehabilitation only focused on linguistic processes.

Linguistic rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First stroke
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital Pierre Paul Riquet

Toulouse, Midi-Pyrénées, 31059, France

Location

Related Publications (7)

• 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.

  PMID: 25133085 BACKGROUND

• 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.

  PMID: 12649521 BACKGROUND

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

  PMID: 24904925 BACKGROUND

• 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.

  PMID: 2594878 BACKGROUND

• 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.

  PMID: 2627547 BACKGROUND

• 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.

  PMID: 18720316 BACKGROUND

• 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.

  PMID: 3730272 BACKGROUND

MeSH Terms

Conditions

Aphasia; Communication

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Lola Danet, Phd

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 19, 2017
• Study Start: March 1, 2018
• Primary Completion: June 30, 2022
• Study Completion: December 27, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

FR (1)