Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia (SEMO)
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
Estado
Condiciones
Condiciones
Intervención / Tratamiento
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
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: University Hospital, Grenoble
- Número de teléfono: +33 04 76 76 68 14
- Correo electrónico: tmontagnon@chu-grenoble.fr
Ubicaciones de estudio
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Grenoble, Francia, 38043
- Reclutamiento
- Chu Grenoble Alpes
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Contacto:
- Baciu Monica
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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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:
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:
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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:
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:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
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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
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
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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
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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
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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
|
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
|
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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
|
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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
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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
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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
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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
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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
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Assessment of functional connectivity with rs-fMRI (resting state-functional MRI). |
Baseline pre-intervention; immediately after the first intervention
|
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Evaluation of brain anatomical connectivity before and after rehabilitation - Evaluation-brain 3
Periodo de tiempo: Baseline pre-intervention; immediately after the first intervention
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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
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Monica Baciu, MD PhD, University Hospital, Grenoble & Laboratoire de Psychologie et NeuroCognition
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Manifestaciones neuroconductuales
- Desordenes comunicacionales
- Trastornos del lenguaje
- Afasia
- Trastornos del habla
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Carrera
- Afasia, Broca
Otros números de identificación del 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)?
Información sobre medicamentos y dispositivos, documentos del estudio
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