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

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04187131
Collaborator
Northeastern University (Other), NSF (Other)
10
2
1
24
5
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: augmented reality
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: augmented reality

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.

Outcome Measures

Primary Outcome Measures

  1. 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;

  2. 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

  1. 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;

  2. 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;

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northeastern University Boston Massachusetts United States 02115
2 University of Pittsburgh Pittsburgh Pennsylvania United States 15260

Sponsors and Collaborators

  • University of Pittsburgh
  • Northeastern University
  • NSF

Investigators

  • Principal Investigator: Murat Akcakaya, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murat Akcakaya, Assistant Professor, Electrical and Computer Engineering, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT04187131
Other Study ID Numbers:
  • STUDY19060390
  • 1915083
First Posted:
Dec 5, 2019
Last Update Posted:
Jun 2, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 2, 2022