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

26. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

48

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: SEJIN KWON, BHS
  • Telefonnummer: +82 10-2939-7143
  • E-post: RQ300@snubh.org

Studiesteder

  • Sør -Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Sør -Korea, 13620
        • Seoul National University Bundang Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Aktiv komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Consonant accuracy (%) and vowel accuracy (%) assessed via U-TAP
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Receptive language score measured by SELSI
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Seoul National University Bundang Hospital

Samarbeidspartnere

National IT Industry Promotion Agency, Republic of Korea

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. juli 2026

Studiet fullført (Antatt)

1. august 2026

Datoer for studieregistrering

Først innsendt

10. mai 2026

Først innsendt som oppfylte QC-kriteriene

26. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • E-2510-1003-301

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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