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

NCT05443542 | Unknown

• 1 other identifier: VR i kogn rehab av tempo
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

TBI; Traumatic brain injury; Stroke; Acquired brain injury; Virtual Reality; VR; Cognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in patient reported executive functioning

  Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)

• Transfer effect to everyday activities

  Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)

• Change in working memory

  Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)

• Change in working memory

  Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)

• Change in informant reported executive functioning

  Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Device: Virtual Reality

Active control group

ACTIVE COMPARATOR

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

Interventions

Virtual Reality DEVICE

Game to be played is a commercially available VR game

Also known as: Oculus Quest 2

Virtual Reality Group

Control intervention OTHER

Sodoku, crossword puzzles

Active control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• Oslo Metropolitan University: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, 1453, Norway

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Brain Injuries; Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marianne Løvstad, PhD

  Sunnaas Rehabilitation hopsital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Løvstad, PhD

CONTACT

+4793452003; marianne.lovstad@sunnaas.no

Sveinung Tornås, PhD

CONTACT

+4799159137; sveinung.tornas@sunnaas.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: July 5, 2022
• Study Start: September 15, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)