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

29 de septiembre de 2026 actualizado por: University Hospital, Grenoble

Evaluación de un programa de rehabilitación del habla enriquecido que combina la terapia del habla y la integración sensoriomotora en pacientes afásicos

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Grenoble, Francia, 38043
        • Reclutamiento
        • Chu Grenoble Alpes
        • Contacto:
          • Baciu Monica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

55 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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).

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.

Otros nombres:
  • Integración sensoriomotora
  • Método de rehabilitación basado en ilustraciones

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.

Otros nombres:
  • Logopedia convencional
Experimental: 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).

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.

Otros nombres:
  • Integración sensoriomotora
  • Método de rehabilitación basado en ilustraciones

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.

Otros nombres:
  • Logopedia convencional

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluation of acoustic changes in the speech signal before and after each rehabilitation protocol
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de mayo de 2022

Finalización primaria (Estimado)

5 de mayo de 2028

Finalización del estudio (Estimado)

5 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

19 de mayo de 2020

Primero enviado que cumplió con los criterios de control de calidad

12 de junio de 2020

Publicado por primera vez (Actual)

16 de junio de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 38RC20.061
  • 2020-A00720-39 (Otro identificador: ID RCB)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .