- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07641127
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
30
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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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.
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 7, 2026
Primary Completion (Actual)
April 29, 2026
Study Completion (Actual)
May 19, 2026
Study Registration Dates
First Submitted
June 4, 2026
First Submitted That Met QC Criteria
June 8, 2026
First Posted (Actual)
June 11, 2026
Study Record Updates
Last Update Posted (Actual)
June 11, 2026
Last Update Submitted That Met QC Criteria
June 8, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Visual Impairment
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; University Ghent; Research Foundation Flanders; Free University of Brussels and other collaboratorsUnknowniVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment (iVision)Visual Perceptual Weakness (Disorder) | Cerebral Visual ImpairmentBelgium
-
National Taiwan University HospitalRecruitingCerebral Visual Impairment | Visual Rehabilitation | Oddball Design | Passive Visual Stimulation | Perceptual LearningTaiwan
-
Novartis PharmaceuticalsCompletedNeovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNVGermany
-
Russell L. WoodsResearch to Prevent Blindness / Lions Club International FoundationNot yet recruitingCentral Visual Impairment
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Clinique Rive GaucheCompletedVisual Impairment in ChildrenFrance
-
Universitaire Ziekenhuizen KU LeuvenVrije Universiteit Brussel; Fund for Scientific Research, Flanders, BelgiumCompletedCerebral Visual ImpairmentBelgium
-
Nantes University HospitalTerminatedCentral or Peripheral Visual ImpairmentFrance
-
Université Catholique de LouvainRecruitingChildren Suffering From Cortical Visual ImpairmentBelgium
Clinical Trials on Adaptive Multi-modal Digital Twin Navigation Training
-
National Yang Ming Chiao Tung UniversityRecruitingObesity, Adolescent | Weight Change, Body | Weight StigmaTaiwan
-
The Cleveland ClinicMichael J. Fox Foundation for Parkinson's ResearchCompletedParkinson DiseaseUnited States
-
Kazimierz Wielki UniversityNational Science Centre, Poland; John Paul II Catholic University of Lublin...CompletedAging | Cognitive Decline | Old Age; DementiaPoland
-
VA Office of Research and DevelopmentCompletedObesity | DysmobilityUnited States
-
Oregon Health and Science UniversityCompletedAmyotrophic Lateral Sclerosis | Muscular Dystrophies | Spinal Cord Injuries | Multiple System Atrophy | Parkinson's Disease and Parkinsonism | Brain Tumor Adult | Locked-in Syndrome | Brainstem StrokeUnited States
-
Beijing Anzhen HospitalBeijing Wispirit Technology Co., LtdNot yet recruitingHypertension | Mild Cognitive ImpairmentChina
-
The University of Texas Health Science Center at...CompletedSchizophrenia | Schizoaffective Disorder
-
Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
-
National Research Center for Rehabilitation Technical...Central South University; Beijing University of Chinese Medicine; Nanjing Brain... and other collaboratorsRecruitingHealthy | Mild Cognitive Impairment (MCI) | Aging | Subjective Cognitive Decline (SCD)China
-
Beijing Friendship HospitalXuanwu Hospital, Beijing; Fu Xing Hospital, Capital Medical UniversityCompletedVascular Cognitive Impairment no DementiaChina