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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443542
• Other study ID #: VR i kogn rehab av tempo
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Sunnaas Rehabilitation Hospital
• Contact: Marianne Løvstad, PhD
• Phone: +4793452003
• Email: marianne.lovstad[@]sunnaas.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• Virtual Reality
Game to be played is a commercially available VR game

Other:
• Control intervention
Sodoku, crossword puzzles

Locations

Country	Name	City	State
Norway	Sunnaas Rehabilitation Hospital	Nesoddtangen	Viken

Sponsors (3)

Lead Sponsor	Collaborator
Sunnaas Rehabilitation Hospital	Norwegian University of Science and Technology, Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in patient reported executive functioning	Behavior Rating Inventory of Executive function (BRIEF-A)	Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Secondary	Transfer effect to everyday activities	Patient Competency Rating Scale	Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Secondary	Change in working memory	Wechslers Adult Intelligence Scale IV, Backwards Digit Span	Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Secondary	Change in working memory	Wechslers Adult Intelligence Scale IV, Digit sequencing test	Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Secondary	Change in informant reported executive functioning	Behavior Rating Inventory of Executive function (BRIEF-A)	Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Secondary	Change in sustained attention	Connors Continous Performance test 3rd edition, Performance variability over time	Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)