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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04629898
Other study ID # 201612HM014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date July 31, 2018

Study information

Verified date November 2020
Source National Taiwan Normal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
multi-task in the real world and virtual reality video sport games
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.

Locations

Country Name City State
Taiwan National Taiwan Normal University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
Primary 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. Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
Primary 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. Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
Primary 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. Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention
Primary 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. 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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