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Exploratory Trial of the "HiDongDong" Language Rehabilitation App for Articulation Delay.

2026년 5월 26일 업데이트: JeeHyun Suh, Seoul National University Bundang Hospital

A Prospective, Single-center, Randomized Controlled, Open-Label, Assessor-Blinded, Investigator-Initiated Exploratory Clinical Trial of the Application-Based Language Rehabilitation Program "HiDongDong" for Improving Language Development in Children Suspected of Articulation and Phonological Delay

The purpose of this study is to evaluate the effectiveness of the AI-based application "HiDongDong" in improving articulation development in children aged 2 to under 14 years with suspected articulation delays. The program provides individualized language training based on a personalized assessment of vulnerable speech sounds. This trial aims to determine whether the digital therapeutic solution can enhance articulation skills and inform future strategies for language rehabilitation in children.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

This exploratory randomized controlled trial (RCT) evaluates the effectiveness of the AI-based application "HiDongDong" in improving articulation in children aged 2 to under 14 years with suspected articulation delays.

1. Study Methods

  1. Screening and Enrollment Children suspected of articulation developmental delay will be assessed for eligibility according to predefined inclusion and exclusion criteria. Eligible participants will be enrolled, randomized, and scheduled for study visits.

  2. Visit 1 - Baseline Assessment

    At the first visit, a blinded assessor will collect demographic data (child's age, sex, and underlying medical conditions) and conduct a single baseline assessment, including the following:

    • Language assessments: U-TAP (Urimal Test of Articulation and Phonology)

      • SELSI (Sequenced Language Scale for Infants) or PRES (Preschool Receptive- Expressive Language Scale)
    • Functional independence: WeeFIM (Functional Independence Measure for Children)
    • Caregiver emotional status: Satisfaction (5-point Likert scale), depression (BDI; Beck Depression Inventory), anxiety (BAI; Beck Anxiety Inventory)
    • Clinician satisfaction: 5-point Likert scale
  3. Post-Assessment Procedures Following baseline assessment, the control group will be discharged and return home. For the intervention group, a personalized language training program will be generated based on the results of the HiDongDong assessment.
  4. Training and Orientation Participants in the intervention group will receive instruction on how to use the HiDongDong language training program, along with guidance on the study procedures.
  5. Intervention Period The intervention group will complete the HiDongDong language training program at home under caregiver supervision for 4 weeks, 5 sessions per week, 20 minutes per session. Adherence will be monitored throughout the intervention period. The control group will receive language training provided by a speech-language pathologist.
  6. Visit 2 - Post-Intervention Assessment and Study Completion Four weeks after the intervention, both the control and intervention groups will undergo a single post-intervention assessment conducted by a blinded assessor. Upon completion of the assessment, follow-up will be concluded.

2. Comparator and Randomization Participants will be randomized by an independent statistician affiliated with the Medical Research Collaborating Center of the Biomedical Research Institute at Seoul National University Bundang Hospital (SNUBH), using SAS version 9.4.

Assessor blinding will be applied. A blinded assessor (e.g., a hospital-based speech-language pathologist) will conduct all assessments without knowledge of each participant's group allocation, in an independent time and setting.

The sole difference between the two groups is the provider of the intervention:

  • Control group: Language training delivered by a speech-language pathologist
  • Intervention group: Language training delivered via the HiDongDong application (investigational medical device)

Participants will return after 4 weeks for post-intervention assessment by a blinded assessor, after which follow-up will be concluded.

To prevent interim analysis, assessment results will not be disclosed to any study personnel until the dataset is complete.

연구 유형

중재적

등록 (추정된)

48

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: SEJIN KWON, BHS
  • 전화번호: +82 10-2939-7143
  • 이메일: RQ300@snubh.org

연구 장소

  • 대한민국
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, 대한민국, 13620
        • Seoul National University Bundang Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Children aged 2 years to under 14 years
  2. Persistent difficulties in speech sound production, or reduced speech intelligibility that interferes with communicative participation, resulting in limitations in social participation, academic performance, or daily activities
  3. Articulation developmental delay suspected based on U-TAP results, with articulation performance more than 1 standard deviation below the mean for the same age group (-1SD)
  4. Sufficient cognitive ability to follow simple instructions via a mobile device (tablet)
  5. For children under 7 years of age: a caregiver who has received sufficient explanation of the study purpose and procedures and has voluntarily provided written informed consent
  6. For children aged 7 years or older: voluntary assent from the child after sufficient explanation of the study purpose and procedures by the investigator,

in addition to written informed consent from the caregiver

Exclusion Criteria:

  1. Caregiver or child does not consent to study participation, or withdraws consent during the study
  2. U-TAP results indicate articulation development within the normal range, with no suspicion of articulation developmental delay
  3. Difficulty understanding simple instructions or participating in assessments and training due to moderate or severe cognitive impairment, attention deficit, autism spectrum disorder, or similar conditions
  4. Significantly limited speech production due to neuromuscular or anatomical causes, including severe visual impairment or visual field deficits, hearing impairment, cleft palate structural abnormalities, or severe oral/facial muscle dysfunction, resulting in difficulty with articulation
  5. Inability to continue study participation due to acute illness or other conditions that may affect assessment or training during the study period, or unwillingness of the caregiver or child to continue participation
  6. Determination by the principal investigator that study participation may pose a risk to the safety or well-being of the child

Any one of the above exclusion criteria is sufficient for exclusion.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: HiDongDong Intervention
Participants will receive a 4-week individualized articulation training program delivered via the AI-based HiDongDong application. Training will be conducted at home under caregiver monitoring, 5 sessions per week, 20 minutes per session. Adherence and engagement will be monitored. Pre- and post-intervention assessments will measure articulation accuracy, speech intelligibility, and overall language performance.
장치: HiDongDong Intervention
Participants will receive a 4-week individualized articulation training program delivered via the AI-based HiDongDong application. Training is conducted at home under caregiver monitoring, 5 sessions per week, 20 minutes per session. Exercises are tailored to each child's articulation needs based on baseline assessment using U-TAP and the study-specific word list. Adherence and engagement will be monitored.
활성 비교기: Standard Care / Speech Therapist Intervention
Participants will receive standard articulation training conducted by a certified speech-language therapist. Outcome assessments will be conducted at the same time points as the experimental group for comparison.
행동: Standard Care / Speech Therapist Intervention
Participants will receive standard articulation training conducted by a certified speech-language therapist. Outcome assessments will be conducted at the same time points as the experimental group for comparison.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Consonant accuracy (%) and vowel accuracy (%) assessed via U-TAP
기간: Baseline and post-intervention (4 weeks)
Korean Articulation and Phonology Assessment (U-TAP). Changes in articulation accuracy will be evaluated following the 4-week HiDongDong intervention compared to the control group. A blinded speech-language therapist will present picture stimuli, and children's consonant and vowel production will be analyzed at word and sentence levels to identify misarticulations and error patterns.
Baseline and post-intervention (4 weeks)

기타 결과 측정

결과 측정
측정값 설명
기간
Receptive language score measured by SELSI
기간: Baseline and post-intervention (4 weeks)
Receptive language ability is assessed using the Sequenced Language Scale for Infants (SELSI). Higher scores indicate better receptive language comprehension ability.
Baseline and post-intervention (4 weeks)
Receptive language score measured by PRES
기간: Baseline and post-intervention (4 weeks)
Receptive language ability is assessed using the Preschool Receptive-Expressive Language Scale (PRES). Higher scores indicate better receptive language comprehension ability.
Baseline and post-intervention (4 weeks)
Expressive language score measured by SELSI
기간: Baseline and post-intervention (4 weeks)
Expressive language ability is assessed using the Sequenced Language Scale for Infants (SELSI). Higher scores indicate better expressive language ability.
Baseline and post-intervention (4 weeks)
Expressive language score measured by PRES
기간: Baseline and post-intervention (4 weeks)
Expressive language ability is assessed using the Preschool Receptive-Expressive Language Scale (PRES). Higher scores indicate better expressive language ability.
Baseline and post-intervention (4 weeks)
Functional Independence (WeeFIM)
기간: Baseline and post-intervention (4 weeks)
Total score (18-126 points) across 6 domains and 18 items assessing functional independence in daily living activities; higher scores indicate greater independence.
Baseline and post-intervention (4 weeks)
Caregiver Satisfaction
기간: Baseline and post-intervention( 4 weeks)
Caregiver satisfaction assessed using a 5-point Likert scale; higher scores indicate greater satisfaction.
Baseline and post-intervention( 4 weeks)
Caregiver Depression(Beck Depression Inventory)
기간: Baseline and post-intervention (4 weeks)
Caregiver depression assessed using the Beck Depression Inventory (BDI); total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms.
Baseline and post-intervention (4 weeks)
Caregiver Anxiety(Beck Anxiety Inventory)
기간: Baseline and post-intervention( 4 weeks)
Caregiver anxiety assessed using the Beck Anxiety Inventory (BAI); total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms.
Baseline and post-intervention( 4 weeks)
Clinician Satisfaction
기간: Baseline and post-intervention( 4 weeks)
Clinician satisfaction assessed using a 5-point Likert scale (1-5); higher scores indicate greater satisfaction.
Baseline and post-intervention( 4 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Seoul National University Bundang Hospital

협력자

National IT Industry Promotion Agency, Republic of Korea

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 1일

기본 완료 (추정된)

2026년 7월 1일

연구 완료 (추정된)

2026년 8월 1일

연구 등록 날짜

최초 제출

2026년 5월 10일

QC 기준을 충족하는 최초 제출

2026년 5월 26일

처음 게시됨 (실제)

2026년 5월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 26일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • E-2510-1003-301

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data collected during the study will not be shared, in order to protect the privacy of pediatric participants and in accordance with institutional policy.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

언어 발달 장애에 대한 임상 시험

HiDongDong Intervention에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다