An investigator-initiated, prospective, single-center, randomized, assessor-blinded, exploratory clinical trial to evaluate the efficacy and safety of an investigational medical device used to improve speech sound production abilities in pediatric patients with articulation and phonological disorders.

The Catholic University of Korea, Incheon St. Mary's Hospital0 个研究点目标入组 50 人开始时间: 2026年7月15日最近更新: 2026年7月20日

适应症

试验速览

暂无简介。

•Subjects aged 36 months or older and 74 months or younger
•Subjects whose native language is Korean
•Subjects who meet one or more of the following criteria or who have been clinically diagnosed with an articulation and phonological disorder
•A. Subjects whose consonant accuracy in the Child Pronunciation Assessment(APAC) / Child Pronunciation Assessment Revised Edition(APAC-R) falls below the age-normative 2.3 percentile
•B. Subjects whose consonant accuracy in the Korean Articulation and Phonology Assessment (U-TAP) or Korean Articulation and Phonology Assessment 2 (UTAP-2)falls below the age-normative -2 standard deviations
•Cases where the guardian has fully understood the purpose and process of the study and has given consent

•Subjects with structural abnormalities of the speech production organs, such as ankyloglossia or cleft palate
•Subjects with hearing or visual impairments
•Subjects wearing orthodontic appliances
•Other subjects whose situation or condition is deemed unsuitable for participation in the clinical trial based on the investigator's judgment

发起方

The Catholic University of Korea, Incheon St. Mary's Hospital