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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027616
Receipt No. R000031645
Scientific Title Verification of the effectiveness of a rehabilitation system with suppression of reciprocity by vibration and virtual reality space
Date of disclosure of the study information 2017/06/03
Last modified on 2017/06/03

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Basic information
Public title Verification of the effectiveness of a rehabilitation system with suppression of reciprocity by vibration and virtual reality space
Acronym Verification of the effectiveness of a rehabilitation system with suppression of reciprocity by vibration and virtual reality space
Scientific Title Verification of the effectiveness of a rehabilitation system with suppression of reciprocity by vibration and virtual reality space
Scientific Title:Acronym Verification of the effectiveness of a rehabilitation system with suppression of reciprocity by vibration and virtual reality space
Region
Japan

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

Objectives
Narrative objectives1 Brain function activation using device
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electroencephalogram
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 . Observe dorsiflexion behavior of ankle joint on VR by switch input

2. Vibration stimulation is performed on the lower leg triceps tendon during dorsiflexion motion in the image
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 1. Those not having sufficient joint mobility
2. Those without sensuous loss
3. Those who are not dementia
4. Those who do not exhibit higher brain dysfunction
Key exclusion criteria 1. Uncontrolled heart failure
2. Acute myocardial infarction
3. Active myocarditis, or pericarditis
4. Unstable angular nature
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
Ten. 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
13. Higher brain dysfunction
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 Faculty science and engineering
Zip code
Address 27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 Prof. Iwata Lab.
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 Faculty science and engineering
Zip code
Address 27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P
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
2017 Year 06 Month 03 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
2016 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 03 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
2017 Year 06 Month 03 Day
Last modified on
2017 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031645

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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