UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027616 |
|---|---|
| Receipt number | 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 | 2022/12/08 09:22:15 |
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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 | 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
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
jubi@waseda.jp
Sponsor or person
Institute
Waseda university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031645
