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

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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.
Interventional

Enrollment (Actual)

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.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
    • Kafrelsheikh
      • 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

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Enrolled in certified special education centers or inclusive schools in Jeddah, Saudi Arabia.
  2. Chronological age between 10.0 and 20.0 years.
  3. Official clinical diagnosis of mild-to-moderate intellectual disability based on DSM-5 criteria.
  4. IQ score ranging between 50 and 69, measured via standardized Arabic versions of Stanford-Binet or WISC-V scales calibrated for the Saudi population.
  5. Classified under the Saudi educational framework as "Educable Intellectual Disability," displaying basic functional communication and the ability to follow two-step verbal commands.
  6. Normal or corrected-to-normal vision and hearing, with manual dexterity to interact with objects.

Exclusion Criteria:

  1. Co-occurring severe neurodevelopmental conditions (e.g., profound Autism Spectrum Disorder with severe self-injurious or aggressive behavioral manifestations).
  2. Documented medical history of photosensitive epilepsy or severe vestibulo-ocular reflex disorders triggered by digital or stereoscopic displays.
  3. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
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.
Behavioral: Adaptive Mixed Reality Learning Environment (AMRLE)
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.
Behavioral: Adaptive Mixed Reality Learning Environment (AMRLE)
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

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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Salman Center for Disability Research

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.
January 11, 2026

Primary Completion (Actual)

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.
April 25, 2026

Study Completion (Actual)

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.
May 12, 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).
June 2, 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.
June 9, 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 15, 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 15, 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.
June 9, 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.
June 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.
  • 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.

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