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

NCT ID: NCT05443542

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2024-12-31

Brief Summary

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

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.

Conditions

Traumatic Brain Injury; Stroke; Acquired Brain Injury; Brain Injuries; Brain Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Virtual Reality Group

Group 1 will play a VR game using an Oculus Quest 2 in a home setting

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

Game to be played is a commercially available VR game

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

Group Type: ACTIVE_COMPARATOR

Control intervention

Intervention Type: OTHER

Sodoku, crossword puzzles

Interventions

Virtual Reality

Game to be played is a commercially available VR game

Intervention Type: DEVICE

Control intervention

Sodoku, crossword puzzles

Intervention Type: OTHER

Other Intervention Names

Oculus Quest 2

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo Metropolitan University

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Løvstad, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnaas Rehabilitation hopsital

Locations

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Marianne Løvstad, PhD

Role: CONTACT

marianne.lovstad@sunnaas.no

+4793452003

Sveinung Tornås, PhD

Role: CONTACT

sveinung.tornas@sunnaas.no

+4799159137

Facility Contacts

Anne Catrine Trægde Martinsen, PhD

Role: primary

anne.catrine.traegde.martinsen@sunnaas.no

Other Identifiers

VR i kogn rehab av tempo

Identifier Type: -

Identifier Source: org_study_id