UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023766
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.