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

NCT04433351 | Recruiting

• 2 other identifiers: 38RC20.0612020-A00720-39
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aphasia Non Fluent; Stroke

Keywords

post-stroke aphasia; non-fluent aphasia; speech rehabilitation; neuroimaging; neural reorganization; recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Evaluation of changes in inner speech abilities before and after each rehabilitation protocol - Inner speech testing 1

  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

  Baseline pre-intervention; immediately after the first intervention; immediately after the second intervention

• Clinical language assessment 1a

  Baseline pre-intervention

• Evaluation of changes in language abilities before and after rehabilitation - Clinical language assessment 1b

  Immediately after the first intervention; immediately after the second intervention

• Clinical language assessment 2a

  Baseline pre-intervention

Study Arms (2)

SE cohort

EXPERIMENTAL

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

Device: Enriched rehabilitation; Device: Simple rehabilitation

ES cohort

EXPERIMENTAL

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

Device: Enriched rehabilitation; Device: Simple rehabilitation

Interventions

Enriched rehabilitation DEVICE

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.

Also known as: Sensory-motor integration, Illustration-based rehabilitation method

ES cohort; SE cohort

Simple rehabilitation DEVICE

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.

Also known as: Conventional speech therapy

ES cohort; SE cohort

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire de Psychologie et NeuroCognition: collaborator
• GIPSA-LAB: collaborator

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Aphasia, Broca; Stroke

Condition Hierarchy (Ancestors)

Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Monica Baciu, MD PhD

  University Hospital, Grenoble & Laboratoire de Psychologie et NeuroCognition

  PRINCIPAL INVESTIGATOR

Central Study Contacts

University Hospital, Grenoble

CONTACT

04 76 76 68 14; tmontagnon@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two types of rehabilitation will be compared, a simple rehabilitation (S, based on conventional speech therapy) and an enriched rehabilitation (E, based on the use of sensory-motor integration in addition to conventional speech therapy). The investigators will constitute two cohorts of patients (N=18 per cohort): a cohort SE which will carry out first the simple rehabilitation protocol followed by enriched rehabilitation, and a cohort ES which will carry out first the enriched rehabilitation protocol followed by simple rehabilitation. The protocol starts at T0 (inclusion according to defined criteria) and after a first evaluation (T1), patients will then perform the first part of the rehabilitation protocol during 4 weeks. After these 4 weeks, a second evaluation will be performed (T2). Then, the second part of the rehabilitation protocol will be carried out during 4 weeks. At the end, the T3 evaluation will be performed.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 16, 2020
• Study Start: May 5, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)