UMIN-CTR Clinical Trial

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 Hiroyasu Middle name Last name Iwata
Organization	Waseda university
Division name	Faculty science and engineering
Zip code	162-0042
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 Hiroyasu Middle name Last name Iwata
Organization	Waseda university
Division name	Faculty science and engineering
Zip code	162-0042
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	Waseda university
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

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	2025 Year 03 Month 31 Day
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	2022 Year 12 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031645