NCT07647926

Brief Summary

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…

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 11, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 2, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Mixed RealityDigital Quality of LifeAdaptive LearningSpatial Computing

Outcome Measures

Primary Outcomes (1)

  • Digital Quality of Life Observation Scale (DQoLOS)

    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.

Study Arms (2)

Experimental: Adaptive Mixed Reality

EXPERIMENTAL

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)

Active Control: Conventional Interface

ACTIVE COMPARATOR

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)

Interventions

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 Control: Conventional InterfaceExperimental: Adaptive Mixed Reality

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Special Education Resource Rooms

Cairo, Kafrelsheikh, 33516, Egypt

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
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 15, 2026

Study Start

January 11, 2026

Primary Completion

April 25, 2026

Study Completion

May 12, 2026

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations