Digital Twin Smart Educational Platform for Visually Impaired Navigation Training

June 8, 2026 updated by: Abdellah Ibrahim Mohammed Elfeky, King Salman Center for Disability Research

A Digital Twin Smart Educational Platform for Simulating Physical Obstacles and Safe Navigation Training for the Saudi Visually Impaired

This study evaluates a novel digital twin smart educational platform designed to train visually impaired individuals on safe navigation in Saudi urban environments. Independent mobility is challenging for visually impaired people due to dynamic hazards and architectural changes. This interventional study utilizes an advanced computer simulation (digital twin) modeled after real streets in Jeddah, Saudi Arabia. Participants are randomly assigned to either the experimental group (receiving training via the adaptive digital twin platform with 3D spatial audio and wearable haptic feedback) or the control group (receiving traditional orientation and mobility instruction). The training consists of 10 structured sessions over 5 weeks. The primary goal is to determine…

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.

Detailed Description

The purpose of this study is to examine the engineering validity and pedagogical efficacy of the Adaptive Multi-modal Reality Learning Environment (AMRLE) for visually impaired orientation and mobility (O&M) training. The platform features a three-tier architecture: Data Acquisition Tier: Utilizing Mobile Laser Scanning (MLS) and LiDAR point clouds to generate high-fidelity 3D environments compliant with the Saudi Building Code (SBC 201) universal access standards. Processing Tier: Running a custom 3D simulation engine embedded with an AI-driven adaptive algorithm. The algorithm dynamically adjusts environmental complexity and obstacle density based on the user's real-time collision metrics and path deviation speeds. Human Interaction Tier: Delivering sensory...

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.
30

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
      • Cairo, Egypt
        • 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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Certified clinical diagnosis of severe visual impairment or legal blindness.
  • Aged between 18 and 60 years old.
  • Physical ability to walk independently and unassisted for at least 15 continuous minutes.
  • Cognitive and neurological competence to comprehend and interact with multi-modal software telemetry.
  • Baseline proficiency in using accessibility screen-reader features on mobile devices.

Exclusion Criteria:

  • Profound sensorineural hearing loss or auditory dysfunction that prevents 3D spatial binaural sound localization.
  • Active upper or lower-limb motor neuropathies that disrupt the perception of haptic micro-actuator vibrations.
  • History of severe vestibular disorders, severe motion sickness, or inner ear syndromes causing chronic dizziness.
  • Current participation in concurrent physical orientation and mobility clinical trials.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: AMRLE Group
Participants assigned to this group will undergo orientation and mobility (O&M) training within the Adaptive Multi-modal Reality Learning Environment (AMRLE) powered by a dynamic Digital Twin simulation engine. Over a 5-week curriculum comprising 10 structured sessions (25 minutes per session), trainees interact with virtual replicas of real-world Saudi urban layouts. The system delivers non-visual feedback using low-latency 3D spatial binaural audio and localized directional haptic/vibrotactile device telemetry. An AI-driven optimization model automatically scales environmental complexity and obstacle generation based on real-time participant performance loops.
Behavioral: Adaptive Multi-modal Digital Twin Navigation Training
A structured 10-session orientation and mobility (O&M) curriculum distributed over 5 weeks (2 sessions/week, 25 minutes/session). The intervention leverages a dynamic digital twin simulation engine of Saudi urban spaces to proactively train visually impaired users on hazard mitigation. Trainees navigate via non-visual multi-modal feedback loops: 3D spatialized binaural audio (HRTF) pings indicating structural pathways, combined with directional haptic/vibrotactile vest telemetry for real-time proximity boundaries. An AI optimization model continuously adjusts environmental complexity and obstacle generation (static, semi-dynamic, and crowded scenarios) matching the real-time collision metrics of the participant to prevent learning plateaus and optimize cognitive mapping.
Active Comparator: Active Control: Conventional O&M Group
Participants assigned to this control group will undergo standard, conventional orientation and mobility (O&M) rehabilitation instructions. Over a 5-week period consisting of 10 structured training sessions (25 minutes per session), trainees practice navigation along fixed real-world paths using traditional white canes. The instruction relies entirely on conventional tactile maps, physical paving cues, and static verbal orientation scripts provided by an O&M instructor. No virtual reality simulators, adaptive AI algorithms, or high-fidelity digital twin interventions are utilized.
Behavioral: Adaptive Multi-modal Digital Twin Navigation Training
A structured 10-session orientation and mobility (O&M) curriculum distributed over 5 weeks (2 sessions/week, 25 minutes/session). The intervention leverages a dynamic digital twin simulation engine of Saudi urban spaces to proactively train visually impaired users on hazard mitigation. Trainees navigate via non-visual multi-modal feedback loops: 3D spatialized binaural audio (HRTF) pings indicating structural pathways, combined with directional haptic/vibrotactile vest telemetry for real-time proximity boundaries. An AI optimization model continuously adjusts environmental complexity and obstacle generation (static, semi-dynamic, and crowded scenarios) matching the real-time collision metrics of the participant to prevent learning plateaus and optimize cognitive mapping.

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
Real-world Collision Rate (RCR)
Time Frame: At the completion of the 10-session training curriculum (Week 5).
The cumulative number of physical obstacle impacts or structural contact errors recorded per 100 meters during the final real-world post-test field navigation trial.
At the completion of the 10-session training curriculum (Week 5).

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 7, 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 29, 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 19, 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 4, 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 8, 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 11, 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 11, 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 8, 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-2026-053-3
  • KSRG-2026-053 (Other Grant/Funding Number: King Salman center for Disability Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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Medical Conditions

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Conditions

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Dietary Supplements

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