Recruiting

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

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What is being tested

augmented reality

Behavioral
Who is being recruted

Stroke

Over 18 Years
+12 Eligibility Criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2023

Summary

Principal SponsorUniversity of Pittsburgh
Study ContactMurat Akcakaya, PhD
Last updated: July 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2023Actual date on which the first participant was enrolled.

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.

Official TitleAn Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation 
Principal SponsorUniversity of Pittsburgh
Study ContactMurat Akcakaya, PhD
Last updated: July 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Stroke
Criteria
8 inclusion criteria required to participate
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)


4 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Study Objectives
Primary Objectives

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;

number of consecutive sessions attaining Pearson correlation coefficient r greater than.10
Secondary Objectives

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;

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;

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Recruiting
University of PittsburghPittsburgh, United StatesSee the location
Recruiting soon
Northeastern UniversityBoston, United States

Recruiting
2 Study Centers