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

Stroke Clinical Trial

— SEMO  

Official title:

Evaluation of an Enriched Speech Rehabilitation Program Combining Speech Therapy and Sensory-motor Integration in Aphasic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04433351
• Other study ID #: 2020-A00720-39
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Grenoble
• Contact: University Hospital, Grenoble
• Phone: 04 76 76 68 14
• Email: tmontagnon[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with late sub-acute and chronic post-stroke (> 4 months) 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

Related Conditions & MeSH terms

• Aphasia
• Aphasia Non Fluent
• Stroke

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	GIPSA-LAB, Laboratoire de Psychologie et NeuroCognition

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of acoustic changes in the speech signal before and after each rehabilitation protocol	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
Secondary	Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1	Evaluate inner speech abilities with an introspective questionnaire	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Secondary	Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 2	Evaluate inner speech abilities with a behavioral task (homophone detection task)	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Secondary	Clinical language assessment 1a	Assessment of oral and written expression with BDAE (Boston Diagnostic Aphasia Examination).	Baseline pre-intervention
Secondary	Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 1b	Assessment of oral expression (picture naming) with BDAE (Boston Diagnostic Aphasia Examination).	Immediately after the first intervention; immediately after the second intervention
Secondary	Clinical language assessment 2a	Assessment of transcoding (word/sentence repetition and syllable/word reading) with BDAE (Boston Diagnostic Aphasia Examination).	Baseline pre-intervention
Secondary	Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 2b	Assessment of transcoding (word repetition and word reading) with BDAE (Boston Diagnostic Aphasia Examination).	Immediately after the first intervention; immediately after the second intervention
Secondary	Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 3	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
Secondary	Clinical language assessment 4	Assessment of bucco-facial praxia with MT-86 (Montreal-Toulouse aphasia language examination protocol).	Baseline pre-intervention
Secondary	Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 5	Assessment of phonemic discrimination with BALE (Batterie Analytique du Langage Ecrit).	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Secondary	Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 6	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
Secondary	Evaluation of changes in cognitive level before and after each rehabilitation protocol - Neuropsychological assessment 1	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
Secondary	Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 2	Assessment of visuo-spatial span with the Corsi blocks task.	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Secondary	Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 3	Assessment of non-verbal fluency with the Ruff figural fluency test.	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Secondary	Evaluation of changes in specific executive functions before and after each rehabilitation protocol - Neuropsychological assessment 4	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
Secondary	Evaluation of changes in non-verbal episodic memory before and after each rehabilitation protocol - Neuropsychological assessment 5	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
Secondary	Evaluation of changes in mental rotation abilities before and after each rehabilitation protocol - Neuropsychological assessment 6	Assessment of mental rotation abilities.	Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention
Secondary	Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 7	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
Secondary	Evaluation of mood changes before and after each rehabilitation protocol - Neuropsychological assessment 8	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
Secondary	Neuropsychological assessment 9	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
Secondary	Evaluation of brain network activation (with measurement of BOLD, Blood Oxygen Level Dependent) before and after rehabilitation - Evaluation-brain 1	Assessment of brain networks modulation with fMRI (functional MRI) tasks : word repetition (repeating a heard word), picture-prompted rhyme detection (judging if verbal labels of pictures presented in pairs rhyme or not), auditory rhyme detection (decide whether two heard words rhyme of not), picture naming (naming pictures) and word reading (reading visually presented words).	Baseline pre-intervention; immediately after the first intervention
Secondary	Evaluation of brain functional connectivity before and after rehabilitation - Evaluation-brain 2	Assessment of functional connectivity with rs-fMRI (resting state-functional MRI).	Baseline pre-intervention; immediately after the first intervention
Secondary	Evaluation of brain anatomical connectivity before and after rehabilitation - Evaluation-brain 3	Assessment of diffuse white-matter changes in multiple bundles with MRI-DTI (Diffusion Tension Imaging).	Baseline pre-intervention; immediately after the first intervention