NCT02752425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 30, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
Last Updated

September 9, 2025

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

April 21, 2016

Last Update Submit

September 8, 2025

Conditions

Speech Disorders

Keywords

Speech disordersSpeech therapyVisual feedbackBuccopharyngeal surgeryCentral nervous system damage

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Perception test scores

    4 months

Study Arms (2)

With visual feedback

EXPERIMENTAL

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

Without visual feedback

NO INTERVENTION

Session of speech therapy without use of ultrasound echography

Interventions

Visual feedbackDEVICE

Use of ultrasound echography for tongue articulatory visual feedback

With visual feedback

Eligibility Criteria

Age8 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut d'Education Motrice

Eybens, 38320, France

Location

Centre Médical Rocheplane

Saint-Martin-d'Hères, 38400, France

Location

Related Publications (1)

  • Girod-Roux M, Hueber T, Fabre D, Gerber S, Canault M, Bedoin N, Acher A, Beziaud N, Truy E, Badin P. Rehabilitation of speech disorders following glossectomy, based on ultrasound visual illustration and feedback. Clin Linguist Phon. 2020 Sep 1;34(9):826-843. doi: 10.1080/02699206.2019.1700310. Epub 2020 Jan 28.

    PMID: 31992079RESULT

MeSH Terms

Conditions

Speech DisordersCommunication Disorders

Condition Hierarchy (Ancestors)

Language DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Pierre BADIN, PhD

    GIPSA-lab, CNRS, Univ. Grenoble Alpes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 27, 2016

Study Start

May 30, 2016

Primary Completion

May 15, 2018

Study Completion

May 15, 2018

Last Updated

September 9, 2025

Record last verified: 2019-01

Locations

FR(2)