Visual ImpairmentNCT07641127
Digital Twin Smart Educational Platform for Visually Impaired Navigation Training
A study testing Adaptive Multi-modal Digital Twin Navigation Training in people with Visual Impairment, run by King Salman Center for Disability Research at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Visual Impairment
- What is being tested?
- Adaptive Multi-modal Digital Twin Navigation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2026to 19 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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…
Read the 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...
- Conditions
- Visual Impairment
- Being tested
- Adaptive Multi-modal Digital Twin Navigation Training
- Keywords
- Digital Twin, Orientation and Mobility, Haptic Feedback, Assistive Technology, Spatial Audio, Adaptive Learning
- Medical subject headings
- Vision Disorders, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Multi-modal Digital Twin Navigation TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: AMRLE Group | Experimental | 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. Receives: Behavioral: Adaptive Multi-modal Digital Twin Navigation Training |
| Active Control: Conventional O&M Group | Active comparator | 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. Receives: Behavioral: Adaptive Multi-modal Digital Twin Navigation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Collision Rate (RCR)
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.
Measured: At the completion of the 10-session training curriculum (Week 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start7 Jan 2026
- Primary completion29 Apr 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Salman Center for Disability Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdellah Ibrahim Mohammed Elfeky, King Salman Center for Disability Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641127
- Sponsor's protocol ID
- KSRG-2026-053-3
- Other IDs
- KSRG-2026-053
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Twin Smart Educational Platform for Simulating Physical Obstacles and Safe Navigation Training for the Saudi Visually Impaired
- ClinicalTrials.gov ID
- NCT07641127
- Acronym / sponsor ID
- KSRG-2026-053-3
- Conditions
- Visual Impairment
- Keywords
- Digital Twin, Orientation and Mobility, Haptic Feedback, Assistive Technology, Spatial Audio, Adaptive Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Salman Center for Disability ResearchUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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…
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: AMRLE Group | Experimental | Behavioral: Adaptive Multi-modal Digital Twin Navigation TrainingParticipants 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. |
| Active Control: Conventional O&M Group | Active comparator | Behavioral: Adaptive Multi-modal Digital Twin Navigation TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Multi-modal Digital Twin Navigation TrainingA 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. | Behavioural | Active Control: Conventional O&M Group, Experimental: AMRLE Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Multi-modal Digital Twin Navigation Training in people with Visual Impairment, run by King Salman Center for Disability Research at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world Collision Rate (RCR) (time frame: At the completion of the 10-session training curriculum (Week 5).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.