CClinicalTrials.gg
Status unknownNCT05443542Updated Nov 8, 2022

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

An interventional study of Virtual Reality and Control intervention in Traumatic Brain Injury, Stroke and Acquired Brain Injury, sponsored by Sunnaas Rehabilitation Hospital. Status unknown at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Sunnaas Rehabilitation Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Brain Injuries

2,114 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.

This study's planned enrollment of 100 is above the median of 48 across 1,332 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Sunnaas Rehabilitation Hospital is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Virtual Reality Group

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

    Device: Virtual Reality

  • 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

Interventions

  • DeviceVirtual Reality

    Game to be played is a commercially available VR game

    Also known as: Oculus Quest 2

  • OtherControl intervention

    Sodoku, crossword puzzles

06

What researchers measure

Primary outcomes

  1. Change in processing speed

    Connors Continous Performance test 3rd edition, Coefficient of Variation

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

Secondary outcomes

  1. Change in patient reported executive functioning

    Behavior Rating Inventory of Executive function (BRIEF-A)

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

  2. Transfer effect to everyday activities

    Patient Competency Rating Scale

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

  3. Change in working memory

    Wechslers Adult Intelligence Scale IV, Backwards Digit Span

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

  4. Change in working memory

    Wechslers Adult Intelligence Scale IV, Digit sequencing test

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

  5. Change in informant reported executive functioning

    Behavior Rating Inventory of Executive function (BRIEF-A)

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

  6. Change in sustained attention

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Data will be deidentified and will not be made publicly available due to data protection regulations

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05443542
Lead sponsor
Sunnaas Rehabilitation Hospital
Collaborators
Oslo Metropolitan University, Norwegian University of Science and Technology
Responsible party
Sponsor
First posted
Jul 5, 2022
Start date
Sep 15, 2022
Primary completion
Dec 2023 (estimated)
Completion
Dec 2024 (estimated)
Last update
Nov 8, 2022

Study contacts

Marianne Løvstad, PhD
Contact
marianne.lovstad@sunnaas.no
+4793452003
Sveinung Tornås, PhD
Contact
sveinung.tornas@sunnaas.no
+4799159137
Marianne Løvstad, PhD
principal investigator · Sunnaas Rehabilitation hopsital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion