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

Sponsor
Sunnaas Rehabilitation Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05443542
Collaborator
Oslo Metropolitan University (Other), Norwegian University of Science and Technology (Other)
100
1
2
27
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality
  • Other: Control intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Virtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With Acquired Brain Injury
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in processing speed [Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)]

      Connors Continous Performance test 3rd edition, Coefficient of Variation

    Secondary Outcome Measures

    1. Change in patient reported executive functioning [Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)]

      Behavior Rating Inventory of Executive function (BRIEF-A)

    2. Transfer effect to everyday activities [Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)]

      Patient Competency Rating Scale

    3. Change in working memory [Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)]

      Wechslers Adult Intelligence Scale IV, Backwards Digit Span

    4. Change in working memory [Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)]

      Wechslers Adult Intelligence Scale IV, Digit sequencing test

    5. Change in informant reported executive functioning [Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)]

      Behavior Rating Inventory of Executive function (BRIEF-A)

    6. Change in sustained attention [Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)]

      Connors Continous Performance test 3rd edition, Performance variability over time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnaas Rehabilitation Hospital Nesoddtangen Viken Norway 1453

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Marianne Løvstad, PhD, Sunnaas Rehabilitation hopsital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunnaas Rehabilitation Hospital
    ClinicalTrials.gov Identifier:
    NCT05443542
    Other Study ID Numbers:
    • VR i kogn rehab av tempo
    First Posted:
    Jul 5, 2022
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sunnaas Rehabilitation Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 5, 2022