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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02752425
Other study ID # 69HCL15_0736
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2016
Est. completion date May 15, 2018

Study information

Verified date January 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 15, 2018
Est. primary completion date May 15, 2018
Accepts healthy volunteers No
Gender All
Age group 8 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Visual feedback
Use of ultrasound echography for tongue articulatory visual feedback

Locations

Country Name City State
France Institut d'Education Motrice Eybens
France Centre Médical Rocheplane Saint Martin d'Hères

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
4 months
Primary 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.
4 months
Secondary 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. 4 months
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