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Trial record 2 of 331 for:    "Speech Disorders"

Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation (REVISON)

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ClinicalTrials.gov Identifier: NCT02752425
Recruitment Status : Recruiting
First Posted : April 27, 2016
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Speech is a privileged means of communication for humans: its trouble can thus prove being extremely handicapping. Standard speech therapy is limited in some cases by the lack of sensory feedback available to the patient (hearing, surgery, neural damage, etc.).

The present study aims at quantify the contribution of the tongue articulatory visual feedback offered by ultrasound echography to speech trouble rehabilitation.

Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and 10 childrens with important speech troubles due to central nervous system damage.

The principle is to conduct standard speech therapy sessions, alternating series of sessions with the use of visual feedback and sessions without visual feedback.

The progress will be regularly measured by means of standard batteries of speech articulation tests.


Condition or disease Intervention/treatment Phase
Speech Disorders Device: Visual feedback Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation
Actual Study Start Date : May 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: With visual feedback
Session of speech therapy conducted with the additional use of articulatory visual feedback based on ultrasound echography, which allows to visualize the patient's tongue in real time on a computer screen
Device: Visual feedback
Use of ultrasound echography for tongue articulatory visual feedback

No Intervention: Without visual feedback
Session of speech therapy without use of ultrasound echography



Primary Outcome Measures :
  1. BECD test score [ Time Frame: 4 months ]

    One of the primary outcome will be measured as the difference of increase of total BECD score between the therapy sessions with and without visual feedback.

    BECD ("Batterie d'Evaluation Clinique de la Dysarthrie, Battery of Clinical Evaluation of Dysarthria") is a French speech articulation test.


  2. MBLF test score [ Time Frame: 4 months ]

    The second primary outcome will be measured as the difference of increase of total MBLF score between the therapy sessions with and without visual feedback.

    MBLF ("Motricité Bucco-Linguo-Faciale, Motricity of Mouth, Tongue and Face") is a French speech articulation test.



Secondary Outcome Measures :
  1. Perception test scores [ Time Frame: 4 months ]
    The secondary outcome will be measured as the difference of increase of the scores of perception obtained by a jury listening to a selected set of patients' speech sounds between the therapy sessions with and without visual feedback. The speech sounds are those recorded during the batteries of speech articulation tests.



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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Articulatory troubles needing speech therapy
  • French mother tongue
  • Adult patients [18 ≥ age < 80 years] who underwent buccopharyngeal surgery after cancer diagnostic OR children [8 ≥ age < 18 years] suffering from central nervous system damage

Exclusion Criteria:

  • Incapacity to easily understand the speech therapist instructions
  • People protected by the law
  • People deprived from freedom by judiciary decision
  • Potential allergy to the water-based conducting gel used to ensure good skin - probe contact
  • Overweight if large fatty mass under chin
  • Major edema under chin limiting echogenicity
  • Non corrected vision or hearing problems
  • For the adults: central or peripheral neural damage
  • History of Ear, Nose, and Throat surgery or radiotherapy
  • For the adults: isolated articulatory trouble, former articulatory trouble not treated, disfluency
  • Massive orofacial dyspraxia
  • Posture trouble
  • Motor problem in upper limbs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752425


Contacts
Contact: Pierre BADIN, PhD 4 76 57 48 26 ext +33 pierre.badin@gipsa-lab.grenoble-inp.fr
Contact: Mélanie CANAULT, PhD 4 72 72 79 24 ext +33 melanie.canault@univ-lyon1.fr

Locations
France
Institut d'Education Motrice Recruiting
Eybens, France, 38320
Contact: Virgiliu STAVILA, MD         
Principal Investigator: Virgiliu STAVILA, MD         
Centre Médical Rocheplane Recruiting
Saint Martin d'Hères, France, 38400
Contact: Nicolas BEZIAUD, MD         
Principal Investigator: Nicolas BEZIAUD, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Study Director: Pierre BADIN, PhD GIPSA-lab, CNRS, Univ. Grenoble Alpes

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02752425     History of Changes
Other Study ID Numbers: 69HCL15_0736
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Keywords provided by Hospices Civils de Lyon:
Speech disorders
Speech therapy
Visual feedback
Buccopharyngeal surgery
Central nervous system damage

Additional relevant MeSH terms:
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms