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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Cleft Palate Children; ENT System; Brain Tumor

Treatments: Behavioral: Dose comparison (same intervention)

Study type: Interventional

Funder types: Other

Identifiers

NCT06831396

HKU/HA HKW IRB (Other Identifier)

Central IRB (Other Identifier)

UW 23-522

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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60 participants in 2 patient groups

case group

Other group

Description:

Dose comparison (same intervention)

Treatment:

Behavioral: Dose comparison (same intervention)

Control Group

Other group

Description:

Dose comparison (same intervention)

Treatment:

Behavioral: Dose comparison (same intervention)