- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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).
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Gali Dar, PhD
- Numer telefonu: +972505662054
- E-mail: gdar@univ.haifa.ac.il
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: excercise
will receive speech therapy treatment and, in addition, exercises for the neck and upper extremities.
|
speech therapy treatment and strengthening exercise
|
|
Aktywny komparator: Control
will receive regular speech therapy treatment according to their disorder
|
regular treatment to enhance good pronunciation
|
|
Brak interwencji: healthy control
healthy control for baseline comparison, no treatment
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Treatment success
Ramy czasowe: at completion of intervention - up to 10 weeks
|
number of treatments until good pronunciation is achieved
|
at completion of intervention - up to 10 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
neck muscle strength
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 237/26
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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