UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023766 |
|---|---|
| Receipt number | R000027381 |
| Scientific Title | Interventions to help the rehabilitation of patients with schizophrenia living in the community - Comparison of the virtual reality sports game (VRG)- |
| Date of disclosure of the study information | 2016/08/25 |
| Last modified on | 2017/02/24 09:16:32 |
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Basic information
Public title
Interventions to help the rehabilitation of patients with schizophrenia living in the community - Comparison of the virtual reality sports game (VRG)-
Acronym
Interventions to help the rehabilitation of patients with schizophrenia
Scientific Title
Interventions to help the rehabilitation of patients with schizophrenia living in the community - Comparison of the virtual reality sports game (VRG)-
Scientific Title:Acronym
Interventions to help the rehabilitation of patients with schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effect of VRG (Nintendo Wii TM Sports Resort) on the frontal lobe function of resident schizophrenia patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebral blood flow measurement
We measured cerebral blood flow while playing virtual reality games using
functional near-infrared spectroscopy(fNIRS).
Key secondary outcomes
Details of the survey
1.Basic characteristics
2.Measurement of general mental function
3.Cognitive function scale
4.HRQOL Scale (SF-36)
5.Measurement of physical function
This is evaluated on the following six items of skillfulness and agility (Timed Up and Go), flexibility (functional reach test), balance (one-leg standing test with eyes open), gait (walk 10m at maximum force),muscle endurance (30-second chair test) and muscle force (grip strength).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
This intervention was implemented as one 60-minute session per week for three months.
Interventions/Control_2
During the control period, the same intervention group participated in a normal occupational therapy program during the same period one year later (Jun-Sep).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects attended psychiatric day services at one location in Ishikawa prefecture and two locations in Fukui prefecture. They met all five of the following criteria: 1.diagnosed as "schizophrenic" following the criteria defined by the international classification of diseases (ICD-10);2) not diagnosed with a mental disability, alcoholism or drug addiction;3) aged 18-64 years;4) score of 40 points or more in the Global Assessment of Functioning (GAF; indicating a non-severe mental state) and 5) capable of fully understanding the purpose and content of this research.
Key exclusion criteria
Other than the above
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuko Shimizu |
Organization
Ishikawa Prefectural Nursing University
Division name
Dept.of Psychiatric and Mental Health Nursing
Zip code
Address
1-1,Gakuendai,Kahoku-City,Ishikawa,JAPAN.
TEL
076-281-8300
nshimizu@ishikawa-nu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuko Shimizu |
Organization
Ishikawa Prefectural Nursing University
Division name
Dept.of Psychiatric and Mental Health Nursing
Zip code
Address
1-1,Gakuendai,Kahoku-City,Ishikawa,JAPAN.
TEL
076-281-8300
Homepage URL
nshimizu@ishikawa-nu.ac.jp
Sponsor or person
Institute
Ishikawa Prefectural Nursing University
Dept.of Psychiatric and Mental Health Nursing
Institute
Department
Personal name
Funding Source
Organization
Ishikawa Prefectural Nursing University
Dept.of Psychiatric and Mental Health Nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
ときわ病院（石川県），福井病院（福井県）福仁会病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 25 | Day |
Last modified on
| 2017 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027381
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
