Virtual Reality and Social Cognition After Acquired Brain Injury

NCT05309005 | Unknown

• 1 other identifier: Sosial kognisjon
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TBI; Stroke; Acquired Brain Injury; Brain Injuries

Keywords

Virtual Reality; VR; Social cognition; Emotion recognition; Theory of Mind; Assessment; Ecological validity; TBI; Stroke; Acquired Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Convergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.

  60 minutes

• Divergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.

  60 minutes

• Ecological Validity of VR TASIT assessed with paired sample t-tests.

  60 minutes

Other Outcomes (2)

• Secondary Ecological Validity of VR TASIT assessed with paired sample t-tests.

  60 min

• Presence of VR TASIT versus DT TASIT in patient group assessed with paired sample t-test

  60 minutes

Study Arms (2)

ABI group

The patient group consists of 100 patients with acquired brain injury (e.g. cerebrovascular incidents, anoxia, encephalitis and non-progressive brain tumors)

Behavioral: VR TASIT; Behavioral: DT TASIT

Healthy control group

100 healthy adults will be matched to the patients with respect to age, gender and education.

Behavioral: VR TASIT; Behavioral: DT TASIT

Interventions

VR TASIT BEHAVIORAL

Consists of a Norwegian adaptation of the 59 videos of social scenes that constitute the A Form in the original TASIT. The stimulus material in the Virtual Reality version is perceived through a head mounted display. This allows the test person to watch the scenes in three dimensions and a 360 degree angle, increasing the sense of social presence.

ABI group; Healthy control group

DT TASIT BEHAVIORAL

Consists of a Norwegian adaptation of the 59 videos of social scenes that constitute the A Form in the original TASIT, with identical content as the VR TASIT. The stimulus material in the desktop version is perceived on a two dimensional desktop computer screen.

ABI group; Healthy control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acquired Brain Injury

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, 1453, Norway

RECRUITING

MeSH Terms

Conditions

Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marianne Løvstad, Professor

  Sunnaas Rehabilitation Hospital and University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Løvstad, Professor

CONTACT

+4793452003; marianne.lovstad@sunnaas.no

Martin Matre, can.psychol.

CONTACT

+4795870663; martin.matre@sunnaas.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: September 15, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

NO (1)