Co-design of an AI Rehabilitation Program for Children With Borderline Intellectual Disorder

May 28, 2026 updated by: Jeong Yi Kwon, Samsung Medical Center

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 06351
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Individuals who are unable to participate in interviews or workshops due to communication difficulties or inability to provide informed consent/assent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Tablet-Based AI Cognitive and Language Rehabilitation Program
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.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Once per participant/professional during the interview or workshop session conducted post-intervention (overall data collection through December 2026).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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.
Once per participant/professional during the co-design workshop sessions conducted during the study period (overall data collection through December 2026).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-12-062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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