NCT07641127

Brief 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. 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…

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 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 7, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 4, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Digital TwinOrientation and MobilityHaptic FeedbackAssistive TechnologySpatial AudioAdaptive Learning

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the completion of the 10-session training curriculum (Week 5).

Study Arms (2)

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.

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.

Behavioral: Adaptive Multi-modal Digital Twin Navigation Training

Interventions

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 Control: Conventional O&M GroupExperimental: AMRLE Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Special Education Resource Rooms

Cairo, Egypt

Location

MeSH Terms

Conditions

Vision DisordersOrientation, Spatial

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpatial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
King Salman Center for Disability Research

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 11, 2026

Study Start

January 7, 2026

Primary Completion

April 29, 2026

Study Completion

May 19, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Locations