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Level of Immersion of Virtual Reality and Cognition and Motor Performance in Patients of Schizophrenia Spectrum Disorder

Primary Purpose

Schizophrenia, Virtual Reality, Video Games

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
multi-task in the real world and virtual reality video sport games
Sponsored by
National Taiwan Normal University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan Normal University

Outcomes

Primary Outcome Measures

The changes of Color Trail Test (CTT)
There are two subtests: CTT1 & CTT2. The time spend to complete the two subtest is used representing executive function of the participants.
The changes of Box-and-Block Test
This is a measure of upper limb motor performance. The number of blocks moved in one minute is the score of performance.Both the right and the left arm are tested.
The changes of Timed-Up-and-Go Test
The time spend on completing the following task: standing up from a armless chair, walking ahead for 3 meteters, walking around a stool, walking back to the original chair and sitting down.
The changes of Postural sway while standing quietly
The participants are instructed to stand on a 0.5 meter pressure measurement plate in 3 different standing posture (bilateral foot shoulder width apart, bilateral feet side by side, and tandem stance) and two visual conditions (eyes open v.s. closed. Coordinates of center of pressure(COP) are recorded and output and the the total path length of COP is calculated. The longer the COP path length, the poorer the postural stability.
The changes of Voluntary postural sway
The participants are instructed to stand on a 0.5 meter pressure measurement plate when performing the Functional Reach Test. Coordinates of center of pressure(COP) are recorded and output and the total path length of COP is calculated. The longer the COP path length, the better the dynamic postural control.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2020
Last Updated
November 10, 2020
Sponsor
National Taiwan Normal University
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1. Study Identification

Unique Protocol Identification Number
NCT04629898
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan Normal University

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Virtual Reality, Video Games, Multi-tasks

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
multi-task in the real world and virtual reality video sport games
Intervention Description
This was a 2-staged intervention study. The 1st stage intervention uses multitasks in the real world including stepping exercise, ball-kicking activity and bean-bag tossing activity. The 2nd stage intervention used video sport games conveyed by Xbox Kinect. Tennis and golf games were selected.
Primary Outcome Measure Information:
Title
The changes of Color Trail Test (CTT)
Description
There are two subtests: CTT1 & CTT2. The time spend to complete the two subtest is used representing executive function of the participants.
Time Frame
Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
Title
The changes of Box-and-Block Test
Description
This is a measure of upper limb motor performance. The number of blocks moved in one minute is the score of performance.Both the right and the left arm are tested.
Time Frame
Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
Title
The changes of Timed-Up-and-Go Test
Description
The time spend on completing the following task: standing up from a armless chair, walking ahead for 3 meteters, walking around a stool, walking back to the original chair and sitting down.
Time Frame
Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
Title
The changes of Postural sway while standing quietly
Description
The participants are instructed to stand on a 0.5 meter pressure measurement plate in 3 different standing posture (bilateral foot shoulder width apart, bilateral feet side by side, and tandem stance) and two visual conditions (eyes open v.s. closed. Coordinates of center of pressure(COP) are recorded and output and the the total path length of COP is calculated. The longer the COP path length, the poorer the postural stability.
Time Frame
Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
Title
The changes of Voluntary postural sway
Description
The participants are instructed to stand on a 0.5 meter pressure measurement plate when performing the Functional Reach Test. Coordinates of center of pressure(COP) are recorded and output and the total path length of COP is calculated. The longer the COP path length, the better the dynamic postural control.
Time Frame
Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention .

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jen-Suh Chern, PhD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Normal University
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35771832
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.
Results Reference
derived

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Level of Immersion of Virtual Reality and Cognition and Motor Performance in Patients of Schizophrenia Spectrum Disorder

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