Exploratory Trial of the "HiDongDong" Language Rehabilitation App for Articulation Delay.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-13
SponsorSeoul National University Bundang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 2 years to under 14 years
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
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)
Sufficient cognitive ability to follow simple instructions via a mobile device (tablet)
Disqualifiers
Caregiver or child does not consent to study participation, or withdraws consent during the study
U-TAP results indicate articulation development within the normal range, with no suspicion of articulation developmental delay
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
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
Trial design
Design model
Parallel
Treatments tested in this trial
HiDongDong Intervention
DeviceParticipants 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.
Standard Care / Speech Therapist Intervention
BehavioralParticipants 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: HiDongDong InterventionExperimental treatment 1 intervention
Group B: Standard Care / Speech Therapist InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Consonant accuracy (%) and vowel accuracy (%) assessed via U-TAP
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.
Time frame
Baseline and post-intervention (4 weeks)Other outcomes
1
Receptive language score measured by SELSI
Receptive language ability is assessed using the Sequenced Language Scale for Infants (SELSI). Higher scores indicate better receptive language comprehension ability.
Time frame
Baseline and post-intervention (4 weeks)2
Receptive language score measured by PRES
Receptive language ability is assessed using the Preschool Receptive-Expressive Language Scale (PRES). Higher scores indicate better receptive language comprehension ability.
Time frame
Baseline and post-intervention (4 weeks)3
Expressive language score measured by SELSI
Expressive language ability is assessed using the Sequenced Language Scale for Infants (SELSI). Higher scores indicate better expressive language ability.
Time frame
Baseline and post-intervention (4 weeks)4
Expressive language score measured by PRES
Expressive language ability is assessed using the Preschool Receptive-Expressive Language Scale (PRES). Higher scores indicate better expressive language ability.
Time frame
Baseline and post-intervention (4 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Bundang Hospital
Lead sponsor
National IT Industry Promotion Agency, Republic of Korea
Collaborator
Source ClinicalTrials.gov
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