UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of effectiveness of sitting training equipment using virtual reality for patients with stroke hemiplegia
Title of the study (Brief title)	Verification of effectiveness of sitting training equipment using virtual reality for patients with stroke hemiplegia
Region	Japan

Condition
Condition	stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of effect of sitting training equipment using virtual reality in stroke patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Center of gravity fluctuation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Virtual reality by viewing spatial gradient
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Not dementia
Key exclusion criteria	1. Uncontrolled heart failure 2. Acute myocardial infarction 3. Active myocarditis, or pericarditis 4. Unstable type of narrowness 5. Acute systemic embolism, or pulmonary embolism 6. Acute infection 7. Thrombophlebitis 8. Ventricular tachycardia or refractory ventricular arrhythmia 9. Severe ventricular outflow tract obstruction 10. Uncontrolled arterial hypertension, or pulmonary hypertension 11. If you are in other subjects of intervention study at the same time (verbally verified to the physiotherapist in charge) 12. Excessive contracture
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroyasu Iwata
Organization	Waseda university
Division name	Graduate School of Creative Science and Engineering, Department of Modern Mechanical Engineering
Address	Waseda University, Green Computing System Research Organization 40-603, Waseda-cho 27, Shinjuku-ku, Tokyo
TEL	03-3203-4427
Email	jubi@waseda.jp

Public contact
Name of contact person	Hiroyasu Iwata
Organization	Waseda university
Division name	Graduate School of Creative Science and Engineering, Department of Modern Mechanical Engineering
Address	Waseda University, Green Computing System Research Organization 40-603, Waseda-cho 27, Shinjuku-ku,
TEL	03-3203-4427
Homepage URL
Email	jubi@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Waseda University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 19 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 01 Day
Anticipated trial start date	2018 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
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	2018 Year 12 Month 19 Day
Last modified on	2018 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040237