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

January 2, 2024 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Midi-Pyrénées
      • Toulouse, Midi-Pyrénées, France, 31059
        • Hopital Pierre Paul Riquet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined rehabilitation
Linguistic training as well as communication training.
Other: Combined rehabilitation
Linguistic training as well as communication training.
Active Comparator: Linguistic rehabilitation
Rehabilitation only focused on linguistic processes.
Other: Linguistic rehabilitation
Rehabilitation only focused on linguistic processes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the communication performance.
Time Frame: Month 3
Assessed by the Lillois communication test
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the communication performance.
Time Frame: Month 6
Assessed by the Lillois communication test
Month 6
Assessment of the linguistic performance.
Time Frame: Month 3; Month 6
Assessed by the "Score at understanding task".
Month 3; Month 6
Assessment of the quality of life.
Time Frame: Month 3; Month 6
Assessed by the "Score at a specific quality of life scale ".
Month 3; Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Lola Danet, Phd, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

December 27, 2023

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/16/0018
  • 2017-A02163-50 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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