Stroke Clinical Trial
Official title:
Virtual Reality and Social Cognition After Acquired Brain Injury
The study aim is to improve assessment and understanding of social cognitive impairment after acquired brain injury by developing and validating a virtual reality version of The Awareness of Social Inference Test (TASIT). It is expected that the VR version of the test has comparable or better psychometric properties than the video version, and that it has improved relevance to everyday social skills. It is also expected that the VR version taxes cognitive functions more than a desktop version with identical content as the VR version.
Status | Recruiting |
Enrollment | 200 |
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 skills adequate to understand instructions and dialogues in TASIT videos. Exclusion Criteria: - Severe aphasia affecting their understanding of instructions - Apraxia affecting their ability to use VR-equipment - Visual neglect - Severe mental illness or co-existing neurological disorders |
Country | Name | City | State |
---|---|---|---|
Norway | Sunnaas Rehabilitation Hospital | Nesoddtangen | Viken |
Lead Sponsor | Collaborator |
---|---|
Sunnaas Rehabilitation Hospital | Norwegian University of Science and Technology |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Secondary Ecological Validity of VR TASIT assessed with paired sample t-tests. | It is expected that performance on the VR TASIT correlates with self-reported everyday social functioning, assessed with the Social Skills Questionnaire for TBI (SSQ-TBI). SSQ-TBI taps 16 desirable and 24 undesirable behaviors, which yield negative and positive subscales, respectively. A final item measures a global impression of social functioning. The SSQ-TBI will be translated to Norwegian. | 60 min | |
Other | Presence of VR TASIT versus DT TASIT in patient group assessed with paired sample t-test | It is expected that the VR TASIT is experienced as more immersive than the DT TASIT, assessed with the The Multimodal Presence Scale. The Multimodal Presence Scale measures the perceived physical, social and self-presence in a mediated experience on 15 five-point Likert-type questions. | 60 minutes | |
Primary | Known Groups Validity of VR TASIT assessed with Mann Whitney U test | It is expected that the patient group performs poorer than the control group on the VR TASIT, both total score and scores on each of the three subtests. | 60 minutes | |
Primary | Reliability of VR TASIT in the patient group assessed with paired sample t-tests | The test-retest reliability of VR TASIT in the patient group is determined by re-administering the test 16 weeks after the first administration and calculating the correlation. Analysis of both total score and subscores will be conducted. | 60 minutes | |
Secondary | Convergent Validity of VR TASIT in the patient group assessed with paired sample t-tests. | It is expected that performance on the VR TASIT correlates with performance on three established tests of social cognition, the Hinting Task, the Emotion Recognition Task, and the Interpersonal Reactivity Index.
The Hinting Task is a measure of Theory of Mind that assesses understanding of people's intentions from indirect messages. The task consists of 10 text vignettes of a protagonist expressing an indirect message to another person. Participants are asked to describe the meaning behind the indirect messages. The Emotion Recognition Task (ERT) measures emotion recognition by asking participants to label facial expressions from photographs. The Interpersonal Reactivity Index (IRI) is a measure of empathy, designed to distinguish persons who experience more of the feelings of others from those who are less responsive to the emotional expressions and experiences of others. It contains 28 items that participants answer on a five-point Likert-type scale. |
60 minutes | |
Secondary | Divergent Validity of VR TASIT in the patient group assessed with paired sample t-tests. | Weak to moderate associations between VR-TASIT and measures of mental efficiency, working memory, abstraction and executive functions.
Mental efficiency is assessed with Conners Continuous Performance Test III - Mean Hit Reaction Time. Working Memory is assessed with a composite score consisting of Digit Span Backward and Digit Span Sequencing from the Wechsler Adult Intelligence Scale IV. Abstraction is assessed with a composite score consisting of Similarities and Matrices from the Wechsler Adult Intelligence Scale IV. Three executive functions are assessed: mental flexibility, interference inhibition and sustained attention. Mental flexibility is measured with with Trail Making Test 4 from Delis-Kaplan Executive Function System, interference inhibition is measured with Color Word Interference Test 3 from Delis-Kaplan Executive Function System and sustained attention is measured with Standard deviation of Hit Reaction time from Conners Continuous Performance Test III. |
60 minutes | |
Secondary | Ecological Validity of VR TASIT assessed with paired sample t-tests. | It is expected that performance on the VR TASIT correlates with self-reported everyday social functioning, assessed with the La Trobe Communication Questionnaire (LCQ). LCQ measures impairments in social communication with 30 items rated by patients and informants. The LCQ has been translated into Norwegian and discriminates between people with brain injury and healthy adults. | 60 minutes |
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