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Clinical Trials/NCT04017091
NCT04017091CompletedNot Applicable

The Impact of Virtual Reality Training on Executive and Complex Attentional Functions and Association With Neurorehabilitation Outcomes

Baylor Research Institute0 sites33 target enrollmentStarted: August 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Primary Endpoint
VR Stroop: Change in response times from session1 to session 8 for correct and incongruent trials

Study Overview

Brief Summary

Objective: To determine whether immersive virtual reality (VR) treatment interventions improve executive dysfunction and complex attention deficits in patients with brain injury compared with standard neurorehabilitation, and whether VR performance predicts neurorehabilitation outcomes at discharge.

Design: Mixed design study with quasi-experimental Intervention group (N = 12) and retrospective Control group (N = 12). Both groups were compromised of individuals with brain injury admitted to an outpatient day neurorehabilitation program.

Detailed Description

The current study focuses on repeated practice of a VR-based cognitive intervention with the intent of improving cognitive deficits known to impact ability to resume complex activities. This study details implementation of VR within a neurorehabilitation setting. Associations between the VR Stroop and neuropsychological, speech therapy, and global rehabilitation measures are examined. The investigators include a brain injured control group to address this frequently cited methodological concern.

Inclusion Criteria Patients participating in this study were aged 18 years and older diagnosed with acquired traumatic or non-traumatic neurologic illness, and with dysfunction in executive and attention skills documented during their inpatient rehabilitation course.

Patients that had not yet undergone a neuropsychological evaluation by the time they consented to participate in the study, were administered the Orientation and Cognitive Log (OLOG/Cog-Log) to ensure they were oriented and had sufficient cognitive ability to attend to and understand instructions.

Exclusion Criteria Patients were excluded from participating in the study if they were medically unstable, as deemed by their primary doctor, were aphasic or had hemispatial neglect, had prior history of significant neurological complications or developmental delay resulting in compromised cognition, prisoners, and if they did not speak English.

Participants ABI Patients Twenty-one patients with ABI participated in this pilot study (Figure 1): 9 diagnosed with stroke (43%), 6 with TBI (29%), 2 with anoxic injury (10%), 3 with brain tumor (14%), and 1 with amyloid angiopathy (5%). Six of the 21 patients partially completed the study, but failed to complete all 8 intervention sessions. Two patients were medically withdrawn from Day Neuro due to refractory medical complications, two patients self-discharged from the program against medical advice, and two patients' rehabilitation regimens were concluded prior to their projected discharge dates when insurance or state-assisted benefits were not extended. Of the remaining 15 participants, 12 completed neuropsychological evaluation. The final analyses included 12 patients with ABI who completed VR treatment and all neuropsychological and rehabilitation outcome measures, and 12 Controls with ABI (see Figure 1).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients aged 18 years and older
  • Diagnosis of acquired traumatic or non-traumatic neurologic illness
  • Documented dysfunction in executive and attention skills
  • OLOG/Cog-Log score ≥ 25/30

Exclusion Criteria

  • Medically unstable (as deemed by primary doctor)
  • Hemispatial neglect
  • Prior history of significant neurological complications
  • Prior history of developmental delay resulting in compromised cognition
  • Prisoners
  • Non-English speaking

Arms & Interventions

VR Group

Experimental

ABI Patients Twenty-one patients with ABI participated in this pilot study (Figure 1): 9 diagnosed with stroke (43%), 6 with TBI (29%), 2 with anoxic injury (10%), 3 with brain tumor (14%), and 1 with amyloid angiopathy (5%).

Intervention: Virtual Reality Cognitive Training (Diagnostic Test)

Control Group (Standard Care)

No Intervention

The 12 Controls were age- and gender-matched (and etiology when possible) patients who had previously received traditional neurorehabilitation and completed the same measures as the VR group prior to onset of the study, but they did not receive VR treatment.

Outcomes

Primary Outcomes

VR Stroop: Change in response times from session1 to session 8 for correct and incongruent trials

Time Frame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8

The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was how quickly patient responds to a target on matching (visual color matches aurally presented color) and non-matching trials (visual color does not match aurally presented color). Metric is measured in milliseconds.

VR Stroop: Change in number of total commission errors

Time Frame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8

The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was # of impulsive responses (raw score).

VR Stroop: Change in number of total omission errors

Time Frame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8

The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was # of attentional errors (missed items raw score).

Secondary Outcomes

  • Trail Making Tests (TMT)(After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.)
  • Verbal Fluency Tests (COWAT and Animals)(After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.)
  • Holistic Outcome Measure (HOM): Change in level of independence(HOM home, community, and community participation scores at discharge compared with those at admission.)
  • Mayo-Portland Adaptability Inventory, 4th Edition (MPAI-4): Change in level of independence(MPAI-4 abilities, adjustment, and participation scores at discharge compared with those at admission.)
  • Wechsler Test of Adult Reading (WTAR)(After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.)
  • Stroop Color and Word Test, Golden version(After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.)
  • Functional Assessment of Verbal Reasoning and Executive Strategies (FAVRES)(Week 1 of study and after week 4 of study.)
  • Ross Information Processing Assessment (RIPA), 2nd Edition(Week 1 of study and after week 4 of study.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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