An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
augmented reality
BehavioralThe 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: augmented realityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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;
Time frame
week 42
Reliability; indicated by correlation coefficient between two consecutive sessions of EEG recording
number of consecutive sessions attaining Pearson correlation coefficient r greater than.10
Time frame
week 4Secondary outcomes
1
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;
Time frame
week 42
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;
Time frame
week 4Sponsors and contacts
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Source ClinicalTrials.gov