NCT04629898

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

12 months

First QC Date

November 6, 2020

Last Update Submit

November 10, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 .

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Jen-Suh Chern, PhD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 16, 2020

Study Start

August 1, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

November 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations