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

NCT06831396 | Recruiting DMC

• 3 other identifiers: UW 23-522HKU/HA HKW IRBCentral IRB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Speech Sound Disorder

Keywords

Speech and Language; Children; Treatment; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 20-item probe list accuracy

  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 Outcomes (5)

• Intelligibility in Context Scale (ICS): Traditional Chinese

  Week1, Week 8, Week 16

• Percentage Consonants Correct (PCC)

  Week0, Week 16

• PedsQL TM (Pediatric Quality of Life Inventory TM)

  Week 0, Week 8,Week 16

• Strengths and Difficulties Questionnaire (SDQ)

  Week 0, Week 8, Week16

• Parental Stress Scale (PSS)

  Week0, Week 8, Week 16

Study Arms (2)

Immediate treatment group

EXPERIMENTAL

Ultrasound-aided articulation therapy

Behavioral: Ultrasound-aided articulation therapy

Wait-list Control Group

NO INTERVENTION

No treatment for 4 weeks, and later having the same ultrasound-aided articulation therapy as immediate treatment group

Interventions

Ultrasound-aided articulation therapy 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.

Immediate treatment group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

Related Publications (42)

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Related Links

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

MeSH Terms

Conditions

Speech Sound Disorder; Speech; Language

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders; Verbal Behavior; Communication; Behavior

Central Study Contacts

Oi Yan Yoyo Yiu

CONTACT

5741 3431; h0501126@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 18, 2025
• Study Start: November 11, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)