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Exploratory Clinical Trial of a Medical Device to Improve Articulation and Phonological Accuracy in Pediatric Patients with Articulation and Phonological Disorders

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012271
Enrollment
50
Registered
2026-07-14
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : In addition to existing outpatient speech therapy, subjects in the test group are provided with a digital therapy program using tablet or smartphone applications for 12 weeks. Subject

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects aged 36 months or older and 74 months or younger 2) Subjects whose native language is Korean 3) 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 4) Cases where the guardian has fully understood the purpose and process of the study and has given consent

Exclusion criteria

Exclusion criteria: 1) Subjects with structural abnormalities of the speech production organs, such as ankyloglossia or cleft palate 2) Subjects with hearing or visual impairments 3) Subjects wearing orthodontic appliances 4) Other subjects whose situation or condition is deemed unsuitable for participation in the clinical trial based on the investigator's judgment

Design outcomes

Primary

MeasureTime frame
Change in consonant accuracy on the APAC(Assessment of Phonology and Articulation for Children) or APAC-R(Assessment of Phonology and Articulation for Children-Revised) test after treatment completion compared to baseline;Any undesirable medical or physical finding—such as the occurrence of symptoms not observed prior to the start of the clinical trial or anticipated side effects—is classified as an adverse event.

Secondary

MeasureTime frame
Change in consonant accuracy on the Korean Articulation and Phonological Assessment 2 test after treatment completion compared to baseline;Changes in specific items of the Speech Mechnism Screening Test for children from baseline after the end of treatment: Maximum phonation time, oppositional movement speed, alternating movement speed, continuous movement speed ;Total average score of the User Version of the Mobile Application Rating scale test after the end of treatment

Countries

Korea, Republic of

Contacts

Public Contactso young Han

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

hanqr379@gmail.com+82-32-280-6601

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 23, 2026