Effectiveness of Ultrasound-Aided Articulation Therapy for Children with Speech Sound Disorders

NCT ID: NCT06831396

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-11

Study Completion Date

2025-06-30

Brief Summary

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The study is a prospective randomized controlled procedure to investigate the effect of ultrasound in articulation training and also the effect of treatment intensity in this mode of therapy. Targeted subjects are children with brain tumor or cleft palate with articulation errors which visualization of lingual movement using ultrasound may facilitate their acquisition of the sounds misarticulated. Subjects would be randomized to two groups of high and low treatment intensity, with stratification to the groups by disorders, age and gender whenever possible. Participants will be randomly assigned to either the treatment group or a waitlist control group in a 1:1 ratio.

Detailed Description

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Conditions

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ENT System Cleft Palate Children Brain Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Participants will be randomly assigned to either the treatment group (n=30) or the waitlist control group (n=30), and stratified to the groups by disorders, age and gender whenever possible. The treatment group will receive the intervention immediately, while the waitlist control group will not receive the treatment until the initial treatment group has completed the study. This design allows for a comparison of outcomes between the treatment and control groups, while also ensuring that all participants have the opportunity to receive the treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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case group

Dose comparison (same intervention)

Group Type OTHER

Dose comparison (same intervention)

Intervention Type BEHAVIORAL

The intervention under investigation is a motor-phonetic approach to articulation therapy, enhanced with ultrasound visual biofeedback (UVBF). The treatment group will receive the intervention immediately, while the waitlist control group will receive treatment after the initial group completes the study. This design allows for comparative outcome assessments between both groups, ensuring that all participants ultimately receive treatment.

Control Group

Dose comparison (same intervention)

Group Type OTHER

Dose comparison (same intervention)

Intervention Type BEHAVIORAL

The intervention under investigation is a motor-phonetic approach to articulation therapy, enhanced with ultrasound visual biofeedback (UVBF). The treatment group will receive the intervention immediately, while the waitlist control group will receive treatment after the initial group completes the study. This design allows for comparative outcome assessments between both groups, ensuring that all participants ultimately receive treatment.

Interventions

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Dose comparison (same intervention)

The intervention under investigation is a motor-phonetic approach to articulation therapy, enhanced with ultrasound visual biofeedback (UVBF). The treatment group will receive the intervention immediately, while the waitlist control group will receive treatment after the initial group completes the study. This design allows for comparative outcome assessments between both groups, ensuring that all participants ultimately receive treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* No syndromes or obvious dysmorphic features; No language disorders associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder); No oronasal fistula identified in oral examination or diagnosed velopharyngeal insufficiency; Hearing thresholds between 0 to 25 dB in at least one ear, with no hearing loss exceeding 50 dB in the other; Cantonese as the first language

Exclusion Criteria

* Subjects with syndrome, speech or language disorder associated with biomedical conditions (e.g. cerebral palsy, autism spectrum disorder), hearing threshold higher than 25dB in one ear and hearing loss with more than 50dB in another ear would be excluded from the study. Participants would be excluded fromthe study if they have other planned surgical intervention during the study period.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Yiu Oi Yan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hong Kong Children's Hospital and Child Assessment Centre of The Duchess of Kent Children's Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Oi Yan Yoyo Yiu

Role: CONTACT

5741 3431

Facility Contacts

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Oi Yan Yoyo Yiu, Speech Therapist

Role: primary

+85257413431

References

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Related Links

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https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0034-1388959

9Patients Profile Treated by Speech-language therapy Service, with Emphasis on Language in a Children's Hospital

Other Identifiers

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HKU/HA HKW IRB

Identifier Type: OTHER

Identifier Source: secondary_id

Central IRB

Identifier Type: OTHER

Identifier Source: secondary_id

UW 23-522

Identifier Type: -

Identifier Source: org_study_id

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