- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07647926
Adaptive Mixed Reality for Students With Intellectual Disabilities (AMRLE)
June 9, 2026 updated by: Abdellah Ibrahim Mohammed Elfeky, King Salman Center for Disability Research
Mixed Reality Adaptive Learning Environments for Improving the Digital Quality of Life of Students With Intellectual Disabilities
This study design investigates the empirical efficacy of an Adaptive Mixed Reality Learning Environment (AMRLE) tailored for educable adolescents and young adults (aged 10-20) diagnosed with mild-to-moderate intellectual disabilities in Jeddah, Saudi Arabia.
Standard digital user interfaces often impose heavy cognitive taxes on neurodivergent learners, generating a operational digital divide that limits their independence.
To address this issue, an intelligent application was developed to track behavioral metrics, including response latency and error frequency, dynamically delivery sensory scaffolding, visual pruning, and localized Arabic auditory guidance.
The primary purpose is to systematically evaluate the clinical-pedagogical impact of this dynamic spat…
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
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
-
-
Kafrelsheikh
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Cairo, Kafrelsheikh, Egypt, 33516
- Special Education Resource Rooms
-
-
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
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Enrolled in certified special education centers or inclusive schools in Jeddah, Saudi Arabia.
- Chronological age between 10.0 and 20.0 years.
- Official clinical diagnosis of mild-to-moderate intellectual disability based on DSM-5 criteria.
- IQ score ranging between 50 and 69, measured via standardized Arabic versions of Stanford-Binet or WISC-V scales calibrated for the Saudi population.
- Classified under the Saudi educational framework as "Educable Intellectual Disability," displaying basic functional communication and the ability to follow two-step verbal commands.
- Normal or corrected-to-normal vision and hearing, with manual dexterity to interact with objects.
Exclusion Criteria:
- Co-occurring severe neurodevelopmental conditions (e.g., profound Autism Spectrum Disorder with severe self-injurious or aggressive behavioral manifestations).
- Documented medical history of photosensitive epilepsy or severe vestibulo-ocular reflex disorders triggered by digital or stereoscopic displays.
- Total absence of functional verbal comprehension in Arabic.
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
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Adaptive Mixed Reality
Participants interact with an Adaptive Mixed Reality Learning Environment (AMRLE) via standalone headsets.
The system tracks dynamic telemetry (response latency and error frequency) to deliver automated micro-scaffolding, visual pruning, and Arabic auditory cues to enhance digital quality of life.
|
An interactive 3D spatial computing application configured with an adaptivity engine.
It continuously processes response latency and error frequencies to deliver visual pruning, multi-sensory concrete-to-abstract micro-scaffolding, and Arabic audio prompts tailored for learning digital autonomy and safety.
|
|
Active Comparator: Active Control: Conventional Interface
Participants target identical learning domains and modules using a conventional, non-adaptive touch-screen tablet interface within the same resource room environmental settings.
|
An interactive 3D spatial computing application configured with an adaptivity engine.
It continuously processes response latency and error frequencies to deliver visual pruning, multi-sensory concrete-to-abstract micro-scaffolding, and Arabic audio prompts tailored for learning digital autonomy and safety.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digital Quality of Life Observation Scale (DQoLOS)
Time Frame: Change from baseline (pre-intervention) at Week 0 to post-intervention outcomes at Week 8.
|
A 16-item standardized behavioral observation instrument designed to evaluate the multidimensional constructs of digital quality of life across four primary subscales: digital autonomy, digital safety, digital well-being, and social inclusion.
Each item is scored on a 3-point Likert configuration (3 = Consistently/Autonomous, 2 = Intermittently/Assisted, 1 = Rarely/Dependent).
Total scores range from a minimum of 16 to a maximum of 48, with higher values representing superior digital adaptation and independent technological quality of life.
|
Change from baseline (pre-intervention) at Week 0 to post-intervention outcomes at Week 8.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 11, 2026
Primary Completion (Actual)
April 25, 2026
Study Completion (Actual)
May 12, 2026
Study Registration Dates
First Submitted
June 2, 2026
First Submitted That Met QC Criteria
June 9, 2026
First Posted (Actual)
June 15, 2026
Study Record Updates
Last Update Posted (Actual)
June 15, 2026
Last Update Submitted That Met QC Criteria
June 9, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSRG-2026-053 (King Salman center for Disability Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.