An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT04187131
• Lead Sponsor: University of Pittsburgh

Brief Summary

The aim of this phase is to examine the feasibility and acceptability of the Augmented Reality (AR)-based and electroencephalography (EEG)-based neglect detection and rehabilitation tool.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-05
• Study Start: 2023-06-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-11
• Primary Completion: 2026-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• ages18 and older
• acute stroke
• admitted to inpatient rehabilitation
• presence of neglect (Behavioral Inattention Test total score <129, or scoring below pre-defined cutoff score in at least one of the six subtests)
• more than 10/% missed targets on the Augmented Reality Screening Test
• intact vibration (positive test on Vibration Sensation Test)
• intact auditory function (positive test on Auditory Sensation Test)
• English speaking

Exclusion Criteria

• inability to follow one-step directions at least 80% of the time
• current diagnosis of dementia, Parkinson's disease, multiple sclerosis, or space-occupying tumor
• metal in the head that causes interference with the EEG system
• self-report of previous positive photic stimulation test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Accuracy; indicated by percent agreement between participant report and EEG-based assessment of neglect	week 4	number of sessions attaining greater than 70 percentage agreement between targets identified by the participant and targets identified by EEG; participants view an augmented reality screen with randomly appearing targets in the field of view; when a target is viewed, the participant presses a keyboard key; immediately after, targets randomly appear on the augmented reality screen while the participant's brain activity is recorded by EEG; EEG detects viewed and neglected targets based on brain signals;
Reliability; indicated by correlation coefficient between two consecutive sessions of EEG recording	week 4	number of consecutive sessions attaining Pearson correlation coefficient r greater than.10

Secondary Outcome Measures

Name	Time	Method
Program Satisfaction; indicated by mean score of 3 or greater on the Client Satisfaction Questionnaire	week 4	number of participants attaining greater than or equal to 90 percentage satisfaction; satisfaction is rated on 8 items with a 4-point likert scale, 4 indicating very high satisfaction; items are summed with total a total score of 32 indicating very high satisfaction;
Technology Satisfaction; indicated by a mean score of 3 or higher on the Quebec User Evaluation of Satisfaction with Assistive Technology	week 4	number of participants attaining greater than or equal to 90 percentage satisfaction; satisfaction is rated on 12 items with a 5-point likert scale, 5 indicating very high satisfaction; items are summed with total a total score of 60 indicating very high satisfaction;

Trial Locations

Locations (2)

Northeastern University; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States