UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Trial of Virtual Reality-based Cognitive Assessment for People with Aphasia
Title of the study (Brief title)	Development of Virtual Reality-based Cognitive Assessment
Region	Japan

Condition
Condition	stroke and traumatic brain injury
Classification by specialty	Neurology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop the system of virtual reality-based cognitive assessment for people with aphasia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	neuropsychological assessment
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	person with can understand word comprehension
Key exclusion criteria	person with cannnot see the movie on the PC screen
Target sample size	100

Research contact person
Name of lead principal investigator	Maki Kojima
Organization	Department of Rehabilitation,Nishiyamato Rehabilitation Hspital
Division name	Rehabilitation Dept.
Address	Kanmaki-sho,Kitakaturagi-gun
TEL	0745716688
Email	makiyama.sun@gmail.com

Public contact
Name of contact person	Maki Kojima
Organization	Nishiyamato Rehabilitation Hospital
Division name	Rehabilitaion Dept.
Address	Kanmaki-cho,Kitakaturagi-gun
TEL	0745716688
Homepage URL
Email	makiyama.sun@gmail.com

Sponsor
Institute	Nishiyamato Rehabilitation Hospital
Institute
Department

Funding Source
Organization	KAKENHI
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	西大和リハビリテーション病院(奈良県）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 09 Day
Anticipated trial start date	2012 Year 06 Month 09 Day
Last follow-up date	2017 Year 06 Month 13 Day
Date of closure to data entry	2017 Year 06 Month 13 Day
Date trial data considered complete	2017 Year 06 Month 13 Day
Date analysis concluded	2017 Year 06 Month 13 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	There are significant correlations between VR outcomes and neuropsychological assessments.
Other related information	We should develop the VR systems by decision appropriate outcomes to widely use.

Management information
Registered date	2012 Year 06 Month 09 Day
Last modified on	2017 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009572