VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI
Primary Purpose
Traumatic Brain Injury, Stroke, Acquired Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Virtual Reality
Control intervention
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring TBI, Traumatic brain injury, Stroke, Acquired brain injury, Virtual Reality, VR, 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
Sites / Locations
- Sunnaas Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual Reality Group
Active control group
Arm Description
Group 1 will play a VR game using an Oculus Quest 2 in a home setting
The control group will be given a pamphlet containing exercises affecting working memory, attention and processing speed to be performed in a home setting
Outcomes
Primary Outcome Measures
Change in processing speed
Connors Continous Performance test 3rd edition, Coefficient of Variation
Secondary Outcome Measures
Change in patient reported executive functioning
Behavior Rating Inventory of Executive function (BRIEF-A)
Transfer effect to everyday activities
Patient Competency Rating Scale
Change in working memory
Wechslers Adult Intelligence Scale IV, Backwards Digit Span
Change in working memory
Wechslers Adult Intelligence Scale IV, Digit sequencing test
Change in informant reported executive functioning
Behavior Rating Inventory of Executive function (BRIEF-A)
Change in sustained attention
Connors Continous Performance test 3rd edition, Performance variability over time
Full Information
NCT ID
NCT05443542
First Posted
May 19, 2022
Last Updated
November 7, 2022
Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
Oslo Metropolitan University, Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05443542
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
Oslo Metropolitan University, Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
Group 1 will play a VR game using an Oculus Quest 2 in a home setting
Arm Title
Active control group
Arm Type
Active Comparator
Arm Description
The control group will be given a pamphlet containing exercises affecting working memory, attention and processing speed to be performed in a home setting
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
Oculus Quest 2
Intervention Description
Game to be played is a commercially available VR game
Intervention Type
Other
Intervention Name(s)
Control intervention
Intervention Description
Sodoku, crossword puzzles
Primary Outcome Measure Information:
Title
Change in processing speed
Description
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 Outcome Measure Information:
Title
Change in patient reported executive functioning
Description
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)
Title
Transfer effect to everyday activities
Description
Patient Competency Rating Scale
Time Frame
Measured at baseline, after the intervention period (5 weeks) and at follow-up (16 weeks after baseline)
Title
Change in working memory
Description
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)
Title
Change in working memory
Description
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)
Title
Change in informant reported executive functioning
Description
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)
Title
Change in sustained attention
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Løvstad, PhD
Phone
+4793452003
Email
marianne.lovstad@sunnaas.no
First Name & Middle Initial & Last Name or Official Title & Degree
Sveinung Tornås, PhD
Phone
+4799159137
Email
sveinung.tornas@sunnaas.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Løvstad, PhD
Organizational Affiliation
Sunnaas Rehabilitation hopsital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnaas Rehabilitation Hospital
City
Nesoddtangen
State/Province
Viken
ZIP/Postal Code
1453
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Catrine Trægde Martinsen, PhD
Email
anne.catrine.traegde.martinsen@sunnaas.no
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be deidentified and will not be made publicly available due to data protection regulations
Learn more about this trial
VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI
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