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Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia (SEMO)

2026. szeptember 29. frissítette: University Hospital, Grenoble

A beszédterápiát és a szenzoros-motoros integrációt kombináló, gazdagított beszédrehabilitációs program értékelése afáziás betegeknél

SEMO is a multidisciplinary project (language sciences, cognitive psychology and neuropsychology, physical medicine and rehabilitation, neurology, speech-language pathology, functional neuroimaging and engineering sciences) that aims first, to test and develop a novel speech rehabilitation program designed for patients with non-fluent aphasia and, second, to better describe neural reorganization after successful recovery. To this end, the investigators will conduct a prospective monocentric cross-over study, including two cohorts of post-stroke aphasic patients and two control groups.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

In this project, the investigators propose to evaluate the effectiveness of a new rehabilitation program, based on illustration of speech articulators, to improve speech in patients with non-fluent aphasia. The instigators' method is based on the reinforcement of the interaction between perceptual and motor representations, thanks to the innovative Ultraspeech device. The investigators will exploit a fundamental psycholinguistic principle, which postulates that speech is based both on the activation of the system controlling the motricity of effectors related to word articulation (action) and on the auditory or visual representation of words (perception). The sensory-motor interaction method that the investigators propose allows the patient to perceive phonemes and visualize on a computer screen the movements of the tongue and lips previously recorded by a healthy speaker, typically a speech therapist. Through repeated exercises, the patient is trained to produce sounds correctly, using the correct pronunciation and articulatory movements of the reference speaker as a model. The investigators will compare patients who will follow a classical speech and language therapy rehabilitation program followed by an 'enriched' rehabilitation program including rehabilitation based on sensory-motor interaction associated with speech and language therapy, and vice versa. In order to judge the favorable effect of the rehabilitation program including sensory-motor integration, the following measures will be considered: (a) language skills, (b) phonemic quality, (c) inner speech abilities and (d) cognitive function. Brain language networks will be evaluated with neuroimaging.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

80

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Franciaország
      • Grenoble, Franciaország, 38043
        • Toborzás
        • Chu Grenoble Alpes
        • Kapcsolatba lépni:
          • Baciu Monica

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

55 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria:

  • patients with non-fluent aphasia after lesion in the dominant hemisphere for language
  • native speakers of French
  • normal or corrected to normal vision
  • satisfying all criteria for the MRI examination

Exclusion Criteria:

  • patients with comprehension deficits, hemi-spatial neglect or upper limb apraxia

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Nem véletlenszerű
  • Beavatkozó modell: Crossover kiosztás
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: SE cohort

Patients in the SE cohort will carry out first the simple rehabilitation protocol (S, 4 weeks) followed by enriched rehabilitation (E, 4 weeks).
Eszköz: Enriched rehabilitation

The enriched rehabilitation is based on the use of sensory-motor integration in addition to conventional speech therapy. The sensory-motor integration method is based on the Ultraspeech-player software. This software allows therapists to display movements of speech articulators (tongue and lips) recorded on a reference speaker during production of vowels or consonants (isolated or combined). Sagittal movements of the tongue are recorded using ultrasound and front views of lip movements are captured through video imaging.

During rehabilitation with the Ultraspeech-player software, patients will be seated in front of a computer screen, observe articulatory movements and listen to phonemes. Then, they will be required to repeat each of them five times and move on to the next phoneme, with the agreement of the experimenter.

Más nevek:
  • Érzékszervi-motoros integráció
  • Illusztráció alapú rehabilitációs módszer
Eszköz: Simple rehabilitation

The simple rehabilitation is based on conventional speech therapy. The conventional speech therapy will be provided by the speech therapist. Classically, the speech therapist uses word production with repetition and naming exercises. The therapist will show the patient series of pictures associated or not with written words, and the patient is required to name them and/or read aloud the word. In case of impossibility to perform the task, the therapist may can help the patient by using the indexing method or by asking the patient to repeat after him/her. According to patient's competencies and progress, the difficulty of reeducation can increase progressively.

Más nevek:
  • Hagyományos logopédia
Kísérleti: ES cohort

Patients in the ES cohort will carry out first the enriched rehabilitation protocol (E, 4 weeks) followed by simple rehabilitation (S, 4 weeks).
Eszköz: Enriched rehabilitation

The enriched rehabilitation is based on the use of sensory-motor integration in addition to conventional speech therapy. The sensory-motor integration method is based on the Ultraspeech-player software. This software allows therapists to display movements of speech articulators (tongue and lips) recorded on a reference speaker during production of vowels or consonants (isolated or combined). Sagittal movements of the tongue are recorded using ultrasound and front views of lip movements are captured through video imaging.

During rehabilitation with the Ultraspeech-player software, patients will be seated in front of a computer screen, observe articulatory movements and listen to phonemes. Then, they will be required to repeat each of them five times and move on to the next phoneme, with the agreement of the experimenter.

Más nevek:
  • Érzékszervi-motoros integráció
  • Illusztráció alapú rehabilitációs módszer
Eszköz: Simple rehabilitation

The simple rehabilitation is based on conventional speech therapy. The conventional speech therapy will be provided by the speech therapist. Classically, the speech therapist uses word production with repetition and naming exercises. The therapist will show the patient series of pictures associated or not with written words, and the patient is required to name them and/or read aloud the word. In case of impossibility to perform the task, the therapist may can help the patient by using the indexing method or by asking the patient to repeat after him/her. According to patient's competencies and progress, the difficulty of reeducation can increase progressively.

Más nevek:
  • Hagyományos logopédia

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Evaluation of acoustic changes in the speech signal before and after each rehabilitation protocol
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of acoustic properties (formants, voice onset time and spectral moments) with a phoneme repetition task. Repeated phonemes are isolated vowels, semi-consonants in vowel context and consonants in /a/ context with the consonants (C) placed in initial (/Ca/) or medial (/aCa/) positions.
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Evaluate inner speech abilities with an introspective questionnaire
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 2
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Evaluate inner speech abilities with a behavioral task (homophone detection task)
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Clinical language assessment 1a
Időkeret: Baseline pre-intervention

Assessment of oral and written expression with BDAE (Boston Diagnostic Aphasia Examination).
Baseline pre-intervention
Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 1b
Időkeret: Immediately after the first intervention; immediately after the second intervention

Assessment of oral expression (picture naming) with BDAE (Boston Diagnostic Aphasia Examination).
Immediately after the first intervention; immediately after the second intervention
Clinical language assessment 2a
Időkeret: Baseline pre-intervention

Assessment of transcoding (word/sentence repetition and syllable/word reading) with BDAE (Boston Diagnostic Aphasia Examination).
Baseline pre-intervention
Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 2b
Időkeret: Immediately after the first intervention; immediately after the second intervention

Assessment of transcoding (word repetition and word reading) with BDAE (Boston Diagnostic Aphasia Examination).
Immediately after the first intervention; immediately after the second intervention
Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 3
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of verbal fluency with phonemic and semantic fluency tasks. The patient must generate words that satisfy certain criteria: beginning with a particular letter (phonemic fluency) or belonging to a particular semantic category (semantic fluency).
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Clinical language assessment 4
Időkeret: Baseline pre-intervention

Assessment of bucco-facial praxia with MT-86 (Montreal-Toulouse aphasia language examination protocol).
Baseline pre-intervention
Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 5
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of phonemic discrimination with BALE (Batterie Analytique du Langage Ecrit).
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 6
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of phonological awareness with a rhyme detection task. The patient must decide whether two heard words rhyme or not.
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of changes in cognitive level before and after each rehabilitation protocol - Neuropsychological assessment 1
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of general cognitive level with CASP (Cognitive Assessment Scale for Stroke Patients). CASP evaluates several abilities (naming, comprehension, inhibition, flexibility etc.) and the global score is out of 36.
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 2
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of visuo-spatial span with the Corsi blocks task.
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 3
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of non-verbal fluency with the Ruff figural fluency test.
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 4
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of executive functions with the TMT A-B (Trail Making Test A-B).
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of changes in non-verbal episodic memory before and after each rehabilitation protocol - Neuropsychological assessment 5
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of non-verbal episodic memory with BEM84 (Batterie d'Efficience Mnésique de Signoret). This test contains an immediate recall task (score out of 12) and a delayed recall task (score out of 12).
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of changes in mental rotation abilities before and after each rehabilitation protocol - Neuropsychological assessment 6
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of mental rotation abilities.
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 7
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of depression with Aphasic Depression Rating Scale (ADRS; score out of 32; a score lower than 7 is for "no depression").
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 8
Időkeret: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

Assessment of anxiety with Hamilton scale (score out of 56; a score lower or equal to 12 is for "normal anxiety"; a score between 12 and 20 is for "mild anxiety"; a score between 20 and 25 is for "moderate anxiety"; a score higher than 25 is for "severe anxiety").
Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Neuropsychological assessment 9
Időkeret: Baseline pre-intervention

Assessment of familiarity degree with digital tools with an in-house test developed by the neuropsychologists from our clinical setting. This task allows to evaluate the use of the computer tools, its frequency of use and the type of activities carried out.
Baseline pre-intervention
Evaluation of brain network activation (with measurement of BOLD, Blood Oxygen Level Dependent) before and after rehabilitation - Evaluation-brain 1
Időkeret: Baseline pre-intervention; immediately after the first intervention

Assessment of brain networks modulation with fMRI (functional MRI) tasks : syllable repetition (repeating a heard syllable), picture-prompted rhyme detection (judging if verbal labels of pictures presented in pairs rhyme or not), and picture naming (naming pictures).
Baseline pre-intervention; immediately after the first intervention
Evaluation of brain functional connectivity before and after rehabilitation - Evaluation-brain 2
Időkeret: Baseline pre-intervention; immediately after the first intervention

Assessment of functional connectivity with rs-fMRI (resting state-functional MRI).
Baseline pre-intervention; immediately after the first intervention
Evaluation of brain anatomical connectivity before and after rehabilitation - Evaluation-brain 3
Időkeret: Baseline pre-intervention; immediately after the first intervention

Assessment of diffuse white-matter changes in multiple bundles with MRI-DTI (Diffusion Tension Imaging).
Baseline pre-intervention; immediately after the first intervention

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University Hospital, Grenoble

Együttműködők

GIPSA-LAB
Laboratoire de Psychologie et NeuroCognition

Nyomozók

  • Kutatásvezető: Monica Baciu, MD PhD, University Hospital, Grenoble & Laboratoire de Psychologie et NeuroCognition

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2022. május 5.

Elsődleges befejezés (Becsült)

2028. május 5.

A tanulmány befejezése (Becsült)

2028. május 5.

Tanulmányi regisztráció dátumai

Először benyújtva

2020. május 19.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2020. június 12.

Első közzététel (Tényleges)

2020. június 16.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. október 2.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 29.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 38RC20.061
  • 2020-A00720-39 (Egyéb azonosító: ID RCB)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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