Clinical trial NCT04629898: Level of Immersion of Virtual Reality and Cognition and Motor Performance in Patients of Schizophrenia Spectrum Disorder
Official title: The Influence of Level of Immersion on Training Effects of Exergaming for Persons With Schizophrenia Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Virtual Reality
Video Games
Multi-tasks
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Schizophrenia Spectrum Disorder (SSD) is the main diagnosis in subjects with mental disability. The number of disabled SSD increased yearly and might be due to the ineffective medical and rehabilitative interventions on improving cognitive and motor function. Innovative and effective training programs are needed to decrease financial burden of medical care and social welfare.

Multi-tasks in real world were found to be effective in improving the sports skill of athletes and multi-tasking ability in the real world. No any study investigates in depth how the multi-tasks affect SSD patients' cognitive and motor performance.

Virtual reality exergaming (VREG) is a new form of multi-tasks incorporating information technology. It has been proved as an effective intervention media for patients with SSD in the single domain of physical fitness. No study exists examining its simultaneous influence in cognition and motor performance in SSD patients.

The purpose of this study is to examine the effects of different forms of multi-tasks on the cognitive and motor performance. The results of this study might be used by clinician treating patients with SSD in clinical decision making regarding to whether or not incorporating contemporary information technology in daily intervention and, furthermore, benefit the SSD more than using only the multi-task in the real world.

A total of 25 patients were recruited and participated in this study. They underwent 2-stage multi-task training. The first stage training used multi-tasks in the real world; the second stage training used new forms of multi-tasks which is virtual reality video sport games conveyed by Xbox Kinect. The training in each stage last for 12 weeks and there were 2 sessions in each week. The training duration in each session was 40 minutes.

All participants were measured at the following three time points: before any training begins, after the 1st stage of training and after the 2nd stage of training. The outcome measures include: upper limb motor function (measured by Box-and-Block Test), cognitive function (measured by Color Trail Test), functional mobility measured by Timed-Up-and-Go Test, and standing stability in 6 stance conditions, and voluntary center of gravity shifts during Functional Reach Test (measured by Footscan pressure measurement system).


Eligibility criteria: Inclusion Criteria:

* (1) diagnosed as schizophrenia or schizoaffective disorder by senior psychiatrists according to DSM-IV criteria and the disease onset was \>1 year ago, (2) been judged as symptomatically stable by therapists, (3) was free of interfering or uncontrolled behaviors, (4) could stand independently for at least 3 minutes and walk 10 m without any mobility aids, (5) was ≥18 years old during recruitment for this study, (6) willing to participate in the study voluntarily

Exclusion Criteria:

* Patients were excluded if they were diagnosed with musculoskeletal impairment in the past year, had significant visual and auditory impairments, with severe cognitive impairment (based on Mini Mental State Examination score \< 18), or were unable to follow verbal instructions or training and evaluation regimen.

Primary outcomes:
measure: The changes of Color Trail Test (CTT)
timeFrame: Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
measure: The changes of Box-and-Block Test
timeFrame: Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
measure: The changes of Timed-Up-and-Go Test
timeFrame: Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
measure: The changes of Postural sway while standing quietly
timeFrame: Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
measure: The changes of Voluntary postural sway
timeFrame: Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention .
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
affiliation: National Taiwan Normal University
name: Jen-Suh Chern, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chien TY, Chern JS, Wang SP, Yang Y. Effects of multitask training on cognition and motor control in people with schizophrenia spectrum disorders. PLoS One. 2022 Jun 30;17(6):e0264745. doi: 10.1371/journal.pone.0264745. eCollection 2022.