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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039037
Receipt No. R000044517
Scientific Title Stability of REIHO standing
Date of disclosure of the study information 2020/01/06
Last modified on 2019/12/31

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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
Email 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
Email nagatomi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Biomedical Engineering
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044517

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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