- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04629898
Level of Immersion of Virtual Reality and Cognition and Motor Performance in Patients of Schizophrenia Spectrum Disorder
The Influence of Level of Immersion on Training Effects of Exergaming for Persons With Schizophrenia Spectrum Disorder
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan
- National Taiwan Normal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The changes of Color Trail Test (CTT)
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
|
There are two subtests: CTT1 & CTT2.
The time spend to complete the two subtest is used representing executive function of the participants.
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Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
|
|
The changes of Box-and-Block Test
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
|
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.
|
Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
|
|
The changes of Timed-Up-and-Go Test
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
|
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.
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Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
|
|
The changes of Postural sway while standing quietly
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
|
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.
|
Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
|
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The changes of Voluntary postural sway
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 .
|
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.
|
Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention .
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jen-Suh Chern, PhD, National Taiwan Normal University
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201612HM014
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
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