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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Brain Diseases; Brain Injuries; Traumatic Brain Injury; Acquired Brain Injury
• Intervention / Treatment: Device: Virtual Reality; Other: Control intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne Løvstad, PhD; Phone Number: +4793452003; Email: marianne.lovstad@sunnaas.no
• Study Contact Backup: Name: Sveinung Tornås, PhD; Phone Number: +4799159137; Email: sveinung.tornas@sunnaas.no

Study Locations

• Norway
  • Viken
    • Nesoddtangen, Viken, Norway, 1453
      • Recruiting
      • Sunnaas Rehabilitation Hospital
      • Contact: Anne Catrine Trægde Martinsen, PhD; Email: anne.catrine.traegde.martinsen@sunnaas.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; Group 1 will play a VR game using an Oculus Quest 2 in a home setting	Device: Virtual Reality; Game to be played is a commercially available VR game; Other Names: Oculus Quest 2
Active Comparator: Active control group; 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; Sodoku, crossword puzzles

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Sunnaas Rehabilitation Hospital
• Collaborators: Norwegian University of Science and Technology; Oslo Metropolitan University
• Investigators: Principal Investigator: Marianne Løvstad, PhD, Sunnaas Rehabilitation hopsital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Virtual Reality; Traumatic brain injury; TBI; Acquired brain injury; Cognitive rehabilitation; VR
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Diseases
• Other Study ID Numbers: VR i kogn rehab av tempo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be deidentified and will not be made publicly available due to data protection regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No