- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07650734
Posture, Tongue Position and Pronunciation
The Relationship Between Posture, Tongue Position and Hebrew Sibilant Consonants Pronunciation, and the Effect of Muscle Strengthening Program in Children and Teenagers
Background: The main speech organ that affects the pronunciation of the various vowels is the tongue. The relationships between posture and voice, and between the position of the tongue at rest and posture, have been proven, but the relationship between pronunciation and posture has not yet been proven. The rationale for examining this relationship is that the imbalance and differing loads in poor neck and head posture cause different muscular arrangements of the muscles that support the jaw, tongue, and neck, which will thus affect pronunciation.
Objectives: To examine the relationship between posture, tongue position, and the correct pronunciation in subjects with and without pronunciation disorders. In addition, to examine the effect of a muscle strengthening program on these characteristics.
Methods: The study will include two parts. The first part will be a cross-sectional study using a questionnaire to examine speech therapists' perceptions of the relationship and importance of posture and pronunciation. The second part will include a prospective interventional clinical study to examine the relationship between tongue position at rest and pronunciation, posture, and muscle strength. In addition, the effect of adding muscle-strengthening training to conventional pronunciation therapy on the process of acquiring correct pronunciation will be examined.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will examine the relationship between posture, tongue position, and correct pronunciation in subjects with and without pronunciation disorders. In addition, we will examine the effect of a muscle-strengthening program on these characteristics.
The first part will include an online questionnaire to examine speech therapists' perceptions of the relationship and importance of posture in speech therapy treatment.
The second part will include a prospective interventional clinical study with participants with and without pronunciation disorders. The evaluation measures will include: assessment of the pronunciation by a speech therapist, assessment of posture (mobile app), assessment of tongue position at rest and during pronunciation (observation and ultrasound), measurement of neck and upper limb muscle strength (manual dynamometer), tongue strength (digital measuring spoon), jaw closing muscle strength (Byte), breathing, and swallowing (observation).
The study group with pronunciation disorder will be divided into 2 groups: the intervention group will receive an exercise program to strengthen the neck and upper-limb muscles in addition to regular speech therapy treatments. The control group will receive the regular speech therapy treatments. The evaluation measures will be reviewed again at the end of the treatment series (up to 10 treatments).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gali Dar, PhD
- Phone Number: +972505662054
- Email: gdar@univ.haifa.ac.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- People with normal hearing
- with and without pronunciation disorders
Exclusion Criteria:
- Children and teenagers who study in special education settings,
- children and teenagers with phonological disorders at the prosodic or segmental level,
- children and teenagers whose parents are under the impression that they do not hear well.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: excercise
will receive speech therapy treatment and, in addition, exercises for the neck and upper extremities.
|
speech therapy treatment and strengthening exercise
|
|
Active Comparator: Control
will receive regular speech therapy treatment according to their disorder
|
regular treatment to enhance good pronunciation
|
|
No Intervention: healthy control
healthy control for baseline comparison, no treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment success
Time Frame: at completion of intervention - up to 10 weeks
|
number of treatments until good pronunciation is achieved
|
at completion of intervention - up to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neck muscle strength
Time Frame: baseline, at completion of intervention - - up to 10 weeks
|
flexion and side flexion neck muscle strength via hand held dynamometer.
Recorded in kilograms of force (kgf)
|
baseline, at completion of intervention - - up to 10 weeks
|
|
Tongue strength
Time Frame: base line, at completion of intervention - - up to 10 weeks
|
Tongue strength will be assessed using a digital measuring spoon.
Measurements will be recorded in g/cm2
|
base line, at completion of intervention - - up to 10 weeks
|
|
Jaw closing strength
Time Frame: base line, at completion of intervention- - up to 10 weeks
|
jaw closing strength via Byte device
|
base line, at completion of intervention- - up to 10 weeks
|
|
Tongue thickness
Time Frame: base line, at completion of intervention- - up to 10 weeks
|
Tongue thickness will be measured using ultrasonography.
Measurements will be recorded in millimeters (cm).
|
base line, at completion of intervention- - up to 10 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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
- 237/26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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