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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187131
• Other study ID #: STUDY19060390
• Secondary ID: 1915083
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: Murat Akcakaya, PhD
• Phone: 412-624-8622
• Email: akcakaya[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• augmented reality
The participants will be wearing an EEG cap and Augmented Reality headset (AR-based EEG-guided system) for 10 sessions with a licensed occupational therapist, provided in addition to usual rehabilitation care (either in inpatient rehabilitation or at home). These sessions will focus on activities of daily living that the participants want to practice. All sessions will last approximately 1 hour. These sessions will be scheduled around the existing therapy schedule to cause the least amount of interference with planned clinical activities.

Locations

Country	Name	City	State
United States	Northeastern University	Boston	Massachusetts
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Northeastern University, NSF

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy; indicated by percent agreement between participant report and EEG-based assessment of neglect	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;	week 4
Primary	Reliability; indicated by correlation coefficient between two consecutive sessions of EEG recording	number of consecutive sessions attaining Pearson correlation coefficient r greater than.10	week 4
Secondary	Technology Satisfaction; indicated by a mean score of 3 or higher on the Quebec User Evaluation of Satisfaction with Assistive Technology	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;	week 4
Secondary	Program Satisfaction; indicated by mean score of 3 or greater on the Client Satisfaction Questionnaire	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;	week 4