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

Not Applicable

Recruiting

• Conditions: Cleft Palate Children; Brain Tumor; ENT System

• Registration Number: NCT06831396
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-11-11
• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Standardized perceptual speech assessment (HKCAT/C-CSAT)	Week0, Week 4, Week 8, Week 16
20-item probe list	Week0, Week4, Week8, Week16
treated and untreated word lists	Week1-3, Week4

Secondary Outcome Measures

Name	Time	Method
Intelligibility in Context Scale (ICS): Traditional Chinese	Week1, Week4, Week 8, Week 16
PedsQL TM (Pediatric Quality of Life Inventory TM)	Week 0, Week 4, Week 8,Week 16
Strengths and Difficulties Questionnaire (SDQ)	Week 0, Week4, Week 8, Week16
Parental Stress Scale (PSS)	Week0, Week 4, Week 8, Week 16
The Hong Kong Cantonese Articulation Test (HKCAT)	Week0
Cantonese-Cleft Speech Assessment Tool (C-CSAT)	Week0
The Hong Kong Cantonese Oral Language Scale (HKCOLAS)	Week0
CLEFT-Q Speech Function Scale, Cantonese version	Week0

Trial Locations

Locations (1)

Hong Kong Children's Hospital and Child Assessment Centre of The Duchess of Kent Children's Hospital; 🇭🇰 Hong Kong, Hong Kong