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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	5 Years - 12 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06831396
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Hong Kong
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Hong Kong
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	ENT System, Cleft Palate Children, Brain Tumor
Study Website:	View Trial Website

Arms & Interventions

Arms

Other: case group

Dose comparison (same intervention)

Other: Control Group

Dose comparison (same intervention)

Interventions

Behavioral: - 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.

Contact a Trial Team

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International Sites

Hong Kong, Hong Kong

Status

Recruiting

Address

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

Hong Kong, ,

Site Contact

Oi Yan Yoyo Yiu, Speech Therapist

[email protected]

+85257413431

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