- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02752425
Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation (REVISON)
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Eybens, France, 38320
- Institut d'Education Motrice
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Saint-Martin-d'Hères, France, 38400
- Centre Médical Rocheplane
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Use of ultrasound echography for tongue articulatory visual feedback
|
|
No Intervention: Without visual feedback
Session of speech therapy without use of ultrasound echography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
4 months
|
|
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. |
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pierre BADIN, PhD, GIPSA-lab, CNRS, Univ. Grenoble Alpes
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL15_0736
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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