UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035315
Receipt No. R000040237
Scientific Title Verification of effectiveness of sitting training equipment using virtual reality for patients with stroke hemiplegia
Date of disclosure of the study information 2018/12/19
Last modified on 2018/12/19

* 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 Verification of effectiveness of sitting training equipment using virtual reality for patients with stroke hemiplegia
Acronym Verification of effectiveness of sitting training equipment using virtual reality for patients with stroke hemiplegia
Scientific Title Verification of effectiveness of sitting training equipment using virtual reality for patients with stroke hemiplegia
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda university
Division name Graduate School of Creative Science and Engineering, Department of Modern Mechanical Engineering
Zip code
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
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda university
Division name Graduate School of Creative Science and Engineering, Department of Modern Mechanical Engineering
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 19 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.