NCT07625592

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
6mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Apr 2026Dec 2026

Study Start

First participant enrolled

April 24, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 12, 2026

Last Update Submit

May 28, 2026

Conditions

Keywords

Borderline Intellectual DisorderArtificial IntelligenceCognitive RehabilitationLanguage RehabilitationExperience-Based Co-Design

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    Once per participant/professional during the co-design workshop sessions conducted during the study period (overall data collection through December 2026).

Study Arms (3)

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

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.

Interventions

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.

Children With Borderline Intellectual Disorder

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 12, 2026

First Posted

June 4, 2026

Study Start

April 24, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 4, 2026

Record last verified: 2026-05

Locations