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

Primary Purpose

Speech Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Visual feedback
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Speech Disorders focused on measuring Speech disorders, Speech therapy, Visual feedback, Buccopharyngeal surgery, Central nervous system damage

Eligibility Criteria

8 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut d'Education Motrice
  • Centre Médical Rocheplane

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

With visual feedback

Without visual feedback

Arm Description

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

Session of speech therapy without use of ultrasound echography

Outcomes

Primary Outcome Measures

BECD test score
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.
MBLF test score
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

Perception test scores
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.

Full Information

First Posted
April 21, 2016
Last Updated
January 22, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02752425
Brief Title
Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation
Acronym
REVISON
Official Title
Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 30, 2016 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Disorders
Keywords
Speech disorders, Speech therapy, Visual feedback, Buccopharyngeal surgery, Central nervous system damage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With visual feedback
Arm Type
Experimental
Arm Description
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
Arm Title
Without visual feedback
Arm Type
No Intervention
Arm Description
Session of speech therapy without use of ultrasound echography
Intervention Type
Device
Intervention Name(s)
Visual feedback
Intervention Description
Use of ultrasound echography for tongue articulatory visual feedback
Primary Outcome Measure Information:
Title
BECD test score
Description
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.
Time Frame
4 months
Title
MBLF test score
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Perception test scores
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre BADIN, PhD
Organizational Affiliation
GIPSA-lab, CNRS, Univ. Grenoble Alpes
Official's Role
Study Director
Facility Information:
Facility Name
Institut d'Education Motrice
City
Eybens
ZIP/Postal Code
38320
Country
France
Facility Name
Centre Médical Rocheplane
City
Saint Martin d'Hères
ZIP/Postal Code
38400
Country
France

12. IPD Sharing Statement

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Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation

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