Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Two patients were medically withdrawn from Day Neuro due to refractory medical complications, two patients self-discharged from the program against medical advice, and two patients' rehabilitation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).

Control Group 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. Their data was obtained via retrospective chart review of patients admitted to Day Neuro between 04/2013 and 07/2014.

Intervention Schedule Patients completed the VR apartment program twice per week for a 4-week period (8 sessions total). The VR interventions replaced 30-60 minutes of speech therapy and/or 30-60 minutes of independent time (time designated for relaxation or completion of therapy assignments) per week of the study. Otherwise, clinical services were not altered (see Appendix 1 for detailed schedule of VR and Day Neuro therapy regimen).

The total duration of sessions 1 and 8 was approximately 60 minutes each. The duration of sessions 2-7 was 30 minutes each. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04017091
Study type Interventional
Source Baylor Research Institute
Contact
Status Completed
Phase N/A
Start date August 1, 2014
Completion date May 30, 2015

See also
  Status Clinical Trial Phase
Completed NCT03911752 - Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage
Completed NCT05265377 - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury N/A
Not yet recruiting NCT05863897 - e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury N/A
Completed NCT02215590 - Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims N/A
Recruiting NCT05443542 - VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI N/A
Recruiting NCT05309005 - Virtual Reality and Social Cognition After Acquired Brain Injury
Recruiting NCT04586842 - Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury N/A
Completed NCT03328221 - Physical Activity on Heart Rate Variability in Patients With Severe Acquired Brain Injury
Active, not recruiting NCT05729165 - Local Vibration in Patients With Severe Acquired Brain Injury N/A
Active, not recruiting NCT05734183 - Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness N/A
Recruiting NCT05440682 - Connectivity in Cranioplasty N/A
Completed NCT04206475 - Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj. N/A
Recruiting NCT02495558 - Cough Assessment in Patients With Severe Acquired Brain Injury N/A
Completed NCT03989388 - Occupational Self-Analysis Programme N/A
Terminated NCT01974635 - Proprioception Testing in Persons With Sensorimotor Impairment N/A
Not yet recruiting NCT01451242 - The Reliability of Heart Rate Variability Among Patients With Brain Injury as Measured by POLAR RC810XE Compared to HOLTER N/A
Completed NCT05052905 - VR-based Remote Rehabilitation for Pediatric ABI N/A
Recruiting NCT06130735 - Impact of Intensive Computerized Cognitive Training N/A
Recruiting NCT04328857 - Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing N/A
Completed NCT04499092 - COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery N/A