Borderline Intellectual Functioning (BIF)NCT07625592
Co-design of an AI Rehabilitation Program for Children With Borderline Intellectual Disorder
An observational study of Borderline Intellectual Functioning (BIF) and Intellectual Disability, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Co-design of an AI Rehabilitation Program for Children With Borderline Intellectual Disorder Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Borderline Intellectual Functioning (BIF), Intellectual Disability
- What is being tested?
- Tablet-Based AI Cognitive and Language Rehabilitation Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Apr 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes school-aged children with borderline intellectual disorder who have prior experience using a tablet-based AI cognitive and language rehabilitation program, their legal guardians, and professionals involved in the development or clinical application of rehabilitation programs for children with borderline intellectual disorder.
Who may be able to join
- School-aged children aged 7 to under 16 years with borderline intellectual disorder who have experienced the tablet-based AI cognitive and language rehabilitation program at least once
- Legal guardians of eligible children
- Developers of the AI rehabilitation program or professionals with expertise in cognition, language, learning, or rehabilitation for children with borderline intellectual disorder
Who cannot join
- Individuals who are unable to participate in interviews or workshops due to communication difficulties or inability to provide informed consent/assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Experience-Based Collaborative Design (Co-design) Study of a Tablet-Based AI Cognitive and Language Rehabilitation Program for School-Aged Children With Borderline Intellectual Disorder
Co-design of an AI Rehabilitation Program for Children With Borderline Intellectual Disorder
Read the detailed description
This study aims to co-design a tablet-based artificial intelligence (AI) cognitive and language rehabilitation program for school-aged children with borderline intellectual disorder using an experience-based collaborative design (EBCD) approach. Children with prior experience using the program, their legal guardians, and relevant professionals will participate in interviews and collaborative workshops to identify user needs and improve program usability.
- Being tested
- Tablet-Based AI Cognitive and Language Rehabilitation Program
- Keywords
- Borderline Intellectual Disorder, Artificial Intelligence, Cognitive Rehabilitation, Language Rehabilitation, Experience-Based Co-Design
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-Based AI Cognitive and Language Rehabilitation ProgramBehavioural
A tablet-based artificial intelligence (AI) cognitive and language rehabilitation program previously experienced by children with borderline intellectual disorder. The study collects user and provider experiences through interviews and collaborative workshops to support experience-based co-design and program improvement.
| Study group | Role | What they receive |
|---|---|---|
| Children With Borderline Intellectual Disorder | School-aged children aged 7 to under 16 years with borderline intellectual disorder who have experienced the tablet-based AI cognitive and language rehabilitation program at least once. Receives: Behavioral: Tablet-Based AI Cognitive and Language Rehabilitation Program | |
| Legal Guardians | Legal guardians of children with borderline intellectual disorder who have experienced the tablet-based AI cognitive and language rehabilitation program. | |
| Developers and Professionals | Developers of the AI rehabilitation program and professionals with clinical expertise in cognition, language, learning, or rehabilitation for children with borderline intellectual disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Themes Regarding Participant Experiences with the AI Rehabilitation Program
Qualitative themes regarding participant experiences with the tablet-based AI cognitive and language rehabilitation program will be identified. In-depth interviews will be conducted with users with borderline intellectual functioning and their legal guardians to explore usability and satisfaction. Additionally, focus group discussions with developers and clinical professionals will be held to gather multidisciplinary insights. All qualitative data will be analyzed using qualitative content analysis to extract key core themes. Therefore, there is no quantitative scale used. Results will be reported as identified thematic categories.
Measured: Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).
Secondary outcomes (2)
Perceived Barriers and Challenges to AI Rehabilitation Program Use
Participant-perceived barriers and challenges related to the use of the tablet-based AI cognitive and language rehabilitation program will be identified. Through semi-structured qualitative interviews with users with borderline intellectual functioning and their legal guardians, as well as focus group discussions with developers and clinical professionals, potential obstacles to program adherence, technical difficulties, and clinical limitations will be explored. All qualitative data will be analyzed using thematic analysis to extract core barrier themes. Therefore, there is no quantitative scale used. Results will be reported as identified thematic categories.
Measured: Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).
Co-design Recommendations for AI Rehabilitation Program Improvement
Recommendations for the improvement and optimization of the tablet-based AI cognitive and language rehabilitation program will be developed. Through collaborative co-design workshops involving users with borderline intellectual functioning, their legal guardians, developers, and clinical professionals, actionable insights regarding feature enhancements and interface modifications will be explored. All qualitative data gathered from the workshops will be analyzed using thematic analysis to synthesize core design recommendations. Therefore, there is no quantitative scale used. Results will be reported as identified thematic categories and recommendation frameworks.
Measured: Once per participant/professional during the co-design workshop sessions conducted during the study period (overall data collection through December 2026).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start24 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Intellectual Functioning (BIF)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Yi Kwon, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625592
- Sponsor's protocol ID
- 2025-12-062
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Experience-Based Collaborative Design (Co-design) Study of a Tablet-Based AI Cognitive and Language Rehabilitation Program for School-Aged Children With Borderline Intellectual Disorder
- ClinicalTrials.gov ID
- NCT07625592
- Acronym / sponsor ID
- 2025-12-062
- Keywords
- Borderline Intellectual Disorder, Artificial Intelligence, Cognitive Rehabilitation, Language Rehabilitation, Experience-Based Co-Design
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Co-design of an AI Rehabilitation Program for Children With Borderline Intellectual Disorder
Detailed description
This study aims to co-design a tablet-based artificial intelligence (AI) cognitive and language rehabilitation program for school-aged children with borderline intellectual disorder using an experience-based collaborative design (EBCD) approach. Children with prior experience using the program, their legal guardians, and relevant professionals will participate in interviews and collaborative workshops to identify user needs and improve program usability.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children With Borderline Intellectual Disorder | – | Behavioral: Tablet-Based AI Cognitive and Language Rehabilitation ProgramSchool-aged children aged 7 to under 16 years with borderline intellectual disorder who have experienced the tablet-based AI cognitive and language rehabilitation program at least once. |
| Legal Guardians | – | –Legal guardians of children with borderline intellectual disorder who have experienced the tablet-based AI cognitive and language rehabilitation program. |
| Developers and Professionals | – | –Developers of the AI rehabilitation program and professionals with clinical expertise in cognition, language, learning, or rehabilitation for children with borderline intellectual disorder. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes school-aged children with borderline intellectual disorder who have prior experience using a tablet-based AI cognitive and language rehabilitation program, their legal guardians, and professionals involved in the development or clinical application of rehabilitation programs for children with borderline intellectual disorder.
Key inclusion criteria (3 listed)
- School-aged children aged 7 to under 16 years with borderline intellectual disorder who have experienced the tablet-based AI cognitive and language rehabilitation program at least once
- Legal guardians of eligible children
- Developers of the AI rehabilitation program or professionals with expertise in cognition, language, learning, or rehabilitation for children with borderline intellectual disorder
Key exclusion criteria (1 listed)
- Individuals who are unable to participate in interviews or workshops due to communication difficulties or inability to provide informed consent/assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet-Based AI Cognitive and Language Rehabilitation ProgramA tablet-based artificial intelligence (AI) cognitive and language rehabilitation program previously experienced by children with borderline intellectual disorder. The study collects user and provider experiences through interviews and collaborative workshops to support experience-based co-design and program improvement. | Behavioural | Children With Borderline Intellectual Disorder |
Primary outcome
Qualitative Themes Regarding Participant Experiences with the AI Rehabilitation Program
Time frame: Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).
Qualitative themes regarding participant experiences with the tablet-based AI cognitive and language rehabilitation program will be identified. In-depth interviews will be conducted with users with borderline intellectual functioning and their legal guardians to explore usability and satisfaction. Additionally, focus group discussions with developers and clinical professionals will be held to gather multidisciplinary insights. All qualitative data will be analyzed using qualitative content analysis to extract key core themes. Therefore, there is no quantitative scale used. Results will be reported as identified thematic categories.
2 secondary outcomes
Perceived Barriers and Challenges to AI Rehabilitation Program Use
Time frame: Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).
Co-design Recommendations for AI Rehabilitation Program Improvement
Time frame: Once per participant/professional during the co-design workshop sessions conducted during the study period (overall data collection through December 2026).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Borderline Intellectual Functioning (BIF)
Not yet recruiting
A Comparative Study of Virtual Reality and Sensory-Adapted Dental Environments for Dental Anxiety Reduction in Individuals With Borderline Intellectual Functioning
Borderline Intellectual Functioning (BIF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Intellectual Functioning (BIF) and Intellectual Disability, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Themes Regarding Participant Experiences with the AI Rehabilitation Program (time frame: Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.