UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Interventions to help the rehabilitation of patients with schizophrenia living in the community - Comparison of the virtual reality sports game (VRG)-
Title of the study (Brief title)	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	Nobuko Shimizu
Organization	Ishikawa Prefectural Nursing University
Division name	Dept.of Psychiatric and Mental Health Nursing
Address	1-1,Gakuendai,Kahoku-City,Ishikawa,JAPAN.
TEL	076-281-8300
Email	nshimizu@ishikawa-nu.ac.jp

Public contact
Name of contact person	Nobuko Shimizu
Organization	Ishikawa Prefectural Nursing University
Division name	Dept.of Psychiatric and Mental Health Nursing
Address	1-1,Gakuendai,Kahoku-City,Ishikawa,JAPAN.
TEL	076-281-8300
Homepage URL
Email	nshimizu@ishikawa-nu.ac.jp

Sponsor
Institute	Ishikawa Prefectural Nursing University Dept.of Psychiatric and Mental Health Nursing
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027381