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CompletedNCT03287544ORACLEUpdated Jan 3, 2024

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

An interventional study of Combined rehabilitation and Linguistic rehabilitation in Aphasia, Acquired, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aphasia, Acquired

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Keywords

  • Aphasia
  • Rehabilitation
  • Communication
  • Linguistics
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Combined rehabilitation

    Linguistic training as well as communication training.

    Other: Combined rehabilitation

  • Active comparator
    Linguistic rehabilitation

    Rehabilitation only focused on linguistic processes.

    Other: Linguistic rehabilitation

Interventions

  • OtherCombined rehabilitation

    Linguistic training as well as communication training.

  • OtherLinguistic rehabilitation

    Rehabilitation only focused on linguistic processes.

05

What researchers measure

Primary outcomes

  1. Assessment of the communication performance.

    Assessed by the Lillois communication test

    Time frame: Month 3

Secondary outcomes

  1. Assessment of the communication performance.

    Assessed by the Lillois communication test

    Time frame: Month 6

  2. Assessment of the linguistic performance.

    Assessed by the "Score at understanding task".

    Time frame: Month 3; Month 6

  3. Assessment of the quality of life.

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

    Time frame: Month 3; Month 6

06

Study locations

1 site
  • Hôpital Pierre Paul Riquet
    Toulouse, Midi-Pyrénées 31059, France
07

References and documents

Publications

  • 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. PubMed 25133085 ↗
  • 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. PubMed 12649521 ↗
  • Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042. PubMed 24904925 ↗
  • 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. PubMed 2594878 ↗
  • 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. PubMed 2627547 ↗
  • 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. PubMed 18720316 ↗
  • 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. PubMed 3730272 ↗
08

Registry details

Key details

Study ID
NCT03287544
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Sep 19, 2017
Start date
Mar 1, 2018
Primary completion
Jun 30, 2022
Completion
Dec 27, 2023
Last update
Jan 3, 2024

Study contacts

Lola Danet, Phd
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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