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Recruiting NCT04433351

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

No phase Interventional Aphasia Non Fluent Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enriched rehabilitation, Simple rehabilitation.
Who it may be relevant to
Registry conditions: Aphasia Non Fluent, Stroke. Basic parameters: 55 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed 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.

Interventions

  • 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 captu
  • Device 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 indexi

Primary outcome measures

  • Evaluation of acoustic changes in the speech signal before and after each rehabilitation protocol [Time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention]
Secondary outcome measures (12)
  • Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1 [Time frame: 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 [Time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention]
  • Clinical language assessment 1a [Time frame: Baseline pre-intervention]
  • Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 1b [Time frame: Immediately after the first intervention; immediately after the second intervention]
  • Clinical language assessment 2a [Time frame: Baseline pre-intervention]
  • Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 2b [Time frame: 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 [Time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention]
  • Clinical language assessment 4 [Time frame: Baseline pre-intervention]
  • Evaluation of changes in language abilities before and after each rehabilitation protocol - Clinical language assessment 5 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Chu Grenoble Alpes — Grenoble

Identifiers

NCT: NCT04433351 · 38RC20.061 · 2020-A00720-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗