VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI

Study Overview
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Brief Summary
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One hundred participants with acquired brain injury (ABI) will be included in a randomized controlled trial, with one group playing a commercially available VR game and the control group doing activities in their everyday as cognitive training. The trial aims to investigate how VR can affect processing speed in the ABI population, and if these effects can transfer into everyday activities. The training will be performed in the participants homes, with assistance provided by the project group via phone or video conference. The training period will last five weeks. Participant's cognitive functions will be measured with questionnaires and neuropsychological tests at the start of the training period, at the end of training and sixteen weeks after the start of the intervention. In depth experiences with VR as a training method will be gathered through performing focus group interviews with some of the participants from the VR group, in addition to self-reported questionnaires from all the participants.

Detailed Description
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A randomized controlled trial (RCT) will be conducted where the experimental intervention is playing a commercial VR game. The VR group will follow a training regime of a 30 min VR session five times per week for 5 weeks. The control group will carry on with treatment as usual, in addition, participants will receive an information booklet covering cognitive training in everyday life. Baseline and outcome measures in terms of neuropsychological assessment and questionnaires will be performed at baseline (T1), at the end of the intervention period (T2) and at the 16-week follow-up (T3). The VR group will train with a rhythm VR game that is considered as a good candidate for basic training of the multifaceted aspects of attention including speed of information processing, selection, sustained attention, shifting/dividing of attention, and working memory. The VR game is selected on the grounds of clinical experience with VR training of processing speed, attention and working memory, and is also suggested in research as suitable games for cognitive rehabilitation.

Official Title
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Virtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With Acquired Brain Injury

Conditions
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Traumatic Brain Injury, Stroke, Acquired Brain Injury, Brain Injuries, Brain Diseases

Intervention / Treatment
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* Device: Virtual Reality
* Other: Control intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in stable phase after Acquired brain injury, minimum one year after injury Physically able to operate VR-technology Norwegian or English skills adequate to understand instructions, play the VR-games and to provide valid responses to assessment methods Exclusion Criteria: Severe aphasia affecting their understanding of instructions Apraxia affecting their ability to use VR-equipment Visual neglect Severe mental illness, substance abuse or co-existing neurological disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Group<br>Group 1 will play a VR game using an Oculus Quest 2 in a home setting | Device: Virtual Reality<br>* Game to be played is a commercially available VR game<br>* Other names: Oculus Quest 2;|
| Active Comparator: Active control group<br>The control group will be given a pamphlet containing exercises affecting working memory, attention and processing speed to be performed in a home setting | Other: Control intervention<br>* Sodoku, crossword puzzles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in processing speed | Connors Continous Performance test 3rd edition, Coefficient of Variation | Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient reported executive functioning | Behavior Rating Inventory of Executive function (BRIEF-A) | Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline) | 
| Transfer effect to everyday activities | Patient Competency Rating Scale | Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline) | 
| Change in working memory | Wechslers Adult Intelligence Scale IV, Backwards Digit Span | Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline) | 
| Change in working memory | Wechslers Adult Intelligence Scale IV, Digit sequencing test | Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline) | 
| Change in informant reported executive functioning | Behavior Rating Inventory of Executive function (BRIEF-A) | Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline) | 
| Change in sustained attention | Connors Continous Performance test 3rd edition, Performance variability over time | Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Traumatic brain injury, Stroke, Acquired brain injury, Virtual Reality, VR, Cognitive rehabilitation