- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07111689
- Original Trial
The Effect of Virtual Reality on Cognitive Skills in Schizophrenia
Virtual Reality for Cognitive Enhancement in Schizophrenia: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a randomized controlled trial and conducted using the CONSORT checklist. Individuals who met the inclusion and exclusion criteria were included in the study. Both groups received traditional occupational therapy intervention, while the intervention group also received virtual reality intervention. All intervention procedures in the study were planned to take place three days a week for eight weeks, with each session lasting 45 minutes. A total of 114 individuals were included in the study; 54 were in the control group and 60 were in the intervention group.
Interventions
Conventional occupational therapy intervention approach was applied in both groups. The intervention group additionally received VR application with Microsoft Xbox 360 and Kinect. The interventions consisted of 45-minute sessions 3 days a week for 8 weeks. The intervention procedures are described in detail below and all interventions were performed by the last author of the study :
Conventional Occupational Therapy Intervention:
1-2. Week: Occupation-based interventions for visual skills Within the framework of the occupational therapy intervention calendar, in the first two weeks, participants were given training on visual memory, figure-ground perception, visual discrimination, visual completion, spatial perception, etc., which are the sub-parameters of visual perception skills. It is aimed to increase the visual skill levels of people by making interventions to improve the parameters. Response plan; As a result of the participants' occupation preferences and evaluation results, it was created and implemented using client-centered occupations that aim to increase people's visual skill levels.
3-6. Week: Social Skills Training In these weeks, it was aimed to develop different social skill levels of the participants by using various occupations related to the problematic areas of social skills with personalized targeted occupations. Within the framework of the intervention plan, various activities were prepared to develop skills such as "listening to others, making requests, expressing positive emotions and expressing unpleasant emotions", which are among the basic social skills areas. In addition, social skills parameters such as communication skills, assertiveness skills, conflict management skills, social life skills, friendship skills, interpersonal skills, health maintenance skills, professional/work skills were also included in the intervention plan. During these weeks, social skills were practiced with different tasks and sequential operations, and the development of memory, attention, orientation, praxis and executive skills was also aimed.
7-8. Week: Interventions for participation problems in ADLs Participants' problems in ADLs were identified through client-centered interviews and assessments, and their participation problems were evaluated in terms of personal, environmental and occupation-related factors. It was aimed to solve these problems by applying a holistic client-centered intervention approach to participation problems. During these weeks, the client-centered intervention approach aimed to improve cognitive functions, especially at the level of executive skills such as problem solving, time management, task initiation and completion.
VR Intervention Procedure In this study, the Xbox 360 gaming console and Kinect sensor were utilized for the virtual reality (VR) intervention. The Xbox 360 functions as an interactive gaming platform, while the Kinect sensor is a motion-detection device that captures users' positions and movements through an integrated camera and sensors.
The selection of games for the VR intervention was conducted in collaboration with experts from various disciplines. The evaluation process considered the cognitive and functional demands required for successful gameplay, the potential skills each game could enhance, and the overall therapeutic purpose of the selected games. Following an independent assessment of each game, nine games were identified as suitable for the intervention. Given that all selected games shared similar functional requirements, participants were provided access to the full set of games to optimize engagement and motivation. The specific games and the cognitive functions they target are detailed in Appendix 1.
The intervention was conducted in a designated unit with a total area of approximately 30 m². To mitigate the risk of falls, the flooring of the intervention space was covered with a soft, impact-absorbing surface.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- University of Health Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (1) age between 18 and 65 years,
- (2) Participants must have been diagnosed with Schizophrenia according to the ICD-10 diagnostic criteria,
- (3) Participants must be able to read and write at a level that will allow them to understand the content of the study,
- (4) There must be no severe cognitive impairment diagnosed that would prevent participation in the study,
- (5) Participants' antipsychotic treatments must be stable (no medication changes in the last 3 months),
- (6) Participants must be competent to provide informed consent
Exclusion Criteria:
- (1) Existence of additional diagnoses such as schizoaffective disorder, bipolar disorder or severe depressive disorder,
- (2) Existence of active substance or alcohol addiction diagnosed in the last 6 months,
- (3) Presence of diseases that may affect cognitive functions such as epilepsy, dementia, Parkinson's disease,
- (4) Exclusion of individuals who have active psychotic episodes or severe agitation during the study period,
- (5) Exclusion of individuals who are at risk of harming themselves or others,
- (6) For female participants, there is pregnancy or breastfeeding,
- (7) There are conditions such as visual or hearing impairment that may prevent active participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
cognitive rehabilitation with conventional occupational therapy intervention
|
1-2.
Week: Occupation-based interventions for visual skills 3-6.
Week: Social Skills Training 7-8.
Week: Interventions for participation problems in ADLs
|
|
Experimental: Study Group
virtual reality intervention in addition to conventional occupational therapy intervention
|
1-2.
Week: Occupation-based interventions for visual skills 3-6.
Week: Social Skills Training 7-8.
Week: Interventions for participation problems in ADLs
In this study, the Xbox 360 gaming console and Kinect sensor were utilized for the virtual reality (VR) intervention.
The Xbox 360 functions as an interactive gaming platform, while the Kinect sensor is a motion-detection device that captures users' positions and movements through an integrated camera and sensors.
The selection of games for the VR intervention was conducted in collaboration with experts from various disciplines.
The evaluation process considered the cognitive and functional demands required for successful gameplay, the potential skills each game could enhance, and the overall therapeutic purpose of the selected games.
Following an independent assessment of each game, nine games were identified as suitable for the intervention.
Given that all selected games shared similar functional requirements, participants were provided access to the full set of games to optimize engagement and motivation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
Time Frame: 1 hour
|
The LOTCA is a performance test that consists of 20 items.
The test includes testing materials such as card decks, colored blocks, a pegboard set, and other items.
Additionally, a manual is provided that defines the cognitive domains assessed and provides administration instructions, and specific scoring guidelines.
The LOTCA was scored on a Likert-type scale from 1 to 4, except for items 1-5 which related to categorization, unstructured Risk Object Classification, and structured Risk Object Classification.
Higher scores indicate better cognitive functions
|
1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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