UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039037 |
|---|---|
| Receipt number | R000044517 |
| Scientific Title | Stability of REIHO standing |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2019/12/31 16:01:41 |
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Basic information
Public title
Stability of REIHO standing
Acronym
Stability of REIHO standing
Scientific Title
Stability of REIHO standing
Scientific Title:Acronym
Stability of REIHO standing
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether traditional REIHO way of training is effective in improving standing stability.
Basic objectives2
Others
Basic objectives -Others
To examine whether traditional REIHO way of training for 2 weeks is effective in improving standing stability as assessed by the variability in the center of pressure.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
variability of center of pressure during standing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Stable standing training of standard REIHO presented as a 5 minutes-movie once a day for 2 weeks at home.
Interventions/Control_2
No treatment control
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer who has not experienced REIHO training before this study and gives full informed consent to the study over the age of 16.
Key exclusion criteria
Any disease, disability or injury that compromises the standing balance measurement and training.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL
022-717-8586
Homepage URL
nagatomi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Biomedical Engineering
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Biomedical Engineering
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine
Address
Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
Tel
022-717-8586
med-kenkyo@grp.tohoku.ac.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
東北大学（宮城県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 06 | 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
| 2019 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 10 | 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
| 2019 | Year | 12 | Month | 31 | Day |
Last modified on
| 2019 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044517
