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

March 7, 2026 updated by: Yiu Oi Yan, The University of Hong Kong

Communication in Children With or Without Biomedical Conditions: Speech and Language Profile, Related Outcomes and Articulation Treatment With Ultrasound

This prospective randomized controlled trial investigates the effect of ultrasound visual biofeedback as an adjunct to articulation therapy in children with speech sound disorders involving lingual targets. The intervention aims to facilitate acquisition of misarticulated sounds by providing real-time visualization of tongue movements. Participants are randomized 1:1 to immediate treatment or wait-list control, with stratification by disorder type, age, and gender where feasible. The wait-list control group continues usual care for 4 weeks before crossing over to receive the same intervention (ethical crossover design).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong Children's Hospital and Child Assessment Centre of The Duchess of Kent Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary diagnosis of speech sound disorder with errors on lingual target sounds
  • Probe accuracy <70% on the primary target sound at baseline
  • Cantonese as the first language
  • Hearing thresholds ≤25 dB in at least one ear, with no hearing loss exceeding 50 dB in the other ear
  • No syndromes or obvious dysmorphic features
  • No language disorders associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder)
  • No oronasal fistula identified on oral examination or diagnosed velopharyngeal insufficiency

Exclusion Criteria:

  • Presence of syndromes or dysmorphic features
  • Language disorder associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder)
  • Hearing thresholds >25 dB in one ear and >50 dB in the other ear Planned surgical intervention during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate treatment group
Ultrasound-aided articulation therapy
Behavioral: Ultrasound-aided articulation therapy
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.
No Intervention: Wait-list Control Group
No treatment for 4 weeks, and later having the same ultrasound-aided articulation therapy as immediate treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
20-item probe list accuracy
Time Frame: Week0, Week4, Week8, Week16
Perceptual accuracy on an individualized 20-item target sound probe spanning varying linguistic levels (single words to narrative), reported in percentage.
Week0, Week4, Week8, Week16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intelligibility in Context Scale (ICS): Traditional Chinese
Time Frame: Week1, Week 8, Week 16
A 7-item parent-report measure of functional intelligibility across communication partners (parents, immediate family, extended family, friends, acquaintances, teachers, strangers), rated on a 5-point scale for each item (total averaged score 1-5); higher scores indicate better intelligibility.
Week1, Week 8, Week 16
Percentage Consonants Correct (PCC)
Time Frame: Week0, Week 16
Derived from standardized perceptual speech assessment (HKCAT), a standardized word-level articulation test. PCC was calculated as the number of consonants produced correctly divided by total consonants, expressed as a percentage.
Week0, Week 16
PedsQL TM (Pediatric Quality of Life Inventory TM)
Time Frame: Week 0, Week 8,Week 16
A 23-item child self-report and parent-proxy measure of health-related quality of life across physical, emotional, social, and school functioning domains (score range 0-100); higher scores indicate better health-related quality of life.
Week 0, Week 8,Week 16
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Week 0, Week 8, Week16
A 25-item parent-report behavioral screening tool assessing emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior (total difficulties score range 0-40); higher scores indicate more behavioral difficulties.
Week 0, Week 8, Week16
Parental Stress Scale (PSS)
Time Frame: Week0, Week 8, Week 16
An 18-item parent self-report measure of stress associated with parenting (score range 18-90); higher scores indicate greater parenting stress.
Week0, Week 8, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2023

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 23-522
  • HKU/HA HKW IRB (Other Identifier: Hong Kong Hospital Authority)
  • Central IRB (Other Identifier: Hong Kong Hospital Authority)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The dataset contains sensitive information from a small number of pediatric participants, including speech recordings, video-derived accuracy scores, and clinical details, which could risk re-identification even after de-identification. Sharing is restricted under our institutional ethics approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Speech Sound Disorder

Clinical Trials on Ultrasound-aided articulation therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe