Clinical trial NCT05443542: VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI
Official title: Virtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
name: Norwegian University of Science and Technology
First posted: 2022-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in processing speed
timeFrame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Secondary outcomes:
measure: Change in patient reported executive functioning
timeFrame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
measure: Transfer effect to everyday activities
timeFrame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
measure: Change in working memory
timeFrame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
measure: Change in working memory
timeFrame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
measure: Change in informant reported executive functioning
timeFrame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
measure: Change in sustained attention
timeFrame: Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Other outcomes:
Locations:
city: Nesoddtangen
country: Norway
facility: Sunnaas Rehabilitation Hospital
state: Viken
Study officials:
affiliation: Sunnaas Rehabilitation hopsital
name: Marianne Løvstad, PhD
role: PRINCIPAL_INVESTIGATOR
References: