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Clinical Trials/NCT05443542
NCT05443542
Recruiting
Not Applicable

Virtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With Acquired Brain Injury

Sunnaas Rehabilitation Hospital1 site in 1 country100 target enrollmentSeptember 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Sunnaas Rehabilitation Hospital
Enrollment
100
Locations
1
Primary Endpoint
Change in processing speed
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2022
End Date
December 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sunnaas Rehabilitation Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in processing speed

Time Frame: 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 Outcomes

  • Change in working memory(Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline))
  • Change in patient reported executive functioning(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))
  • Change in sustained attention(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))

Study Sites (1)

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