SchizophreniaNCT04629898
Level of Immersion of Virtual Reality and Cognition and Motor Performance in Patients of Schizophrenia Spectrum Disorder
A study testing multi-task in the real world and virtual reality video sport games in people with Schizophrenia and Virtual Reality, run by National Taiwan Normal University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Virtual Reality, Video Games
- What is being tested?
- multi-task in the real world and virtual reality video sport games
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
- Conditions
- Schizophrenia, Virtual Reality, Video Games, Multi-tasks
- Being tested
- multi-task in the real world and virtual reality video sport games
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-task in the real world and virtual reality video sport gamesBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: Measured at one week before and after the 1st stage training begin and one week after the end of the 2nd stage intervention .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Aug 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jen-Suh Chern, National Taiwan Normal University
- Investigators
- Jen-Suh Chern, PhD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629898
- Sponsor's protocol ID
- 201612HM014
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35771832
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Level of Immersion on Training Effects of Exergaming for Persons With Schizophrenia Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04629898
- Acronym / sponsor ID
- 201612HM014
- Conditions
- Schizophrenia, Virtual Reality, Video Games, Multi-tasks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-task in the real world and virtual reality video sport gamesThis 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. | Behavioural | – |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Derived from this study: PubMed 35771832Chien 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen-Suh Chern, PhD principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-task in the real world and virtual reality video sport games in people with Schizophrenia and Virtual Reality, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.