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Completed

NCT Number: NCT03287544

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pierre Paul Riquet

Toulouse, Midi-Pyrénées, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined rehabilitation

Other

Linguistic training as well as communication training.

Linguistic rehabilitation

Other

Rehabilitation only focused on linguistic processes.

Primary outcomes

  1. Assessment of the communication performance.

    Time frame: Month 3

    Assessed by the Lillois communication test

Secondary outcomes

  1. Assessment of the communication performance.

    Time frame: Month 6

    Assessed by the Lillois communication test

  2. Assessment of the linguistic performance.

    Time frame: Month 3; Month 6

    Assessed by the "Score at understanding task".

  3. Assessment of the quality of life.

    Time frame: Month 3; Month 6

    Assessed by the "Score at a specific quality of life scale ".

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: ORACLE

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Sep 19, 2017
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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