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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030334
Receipt No. R000034642
Scientific Title Effects of various balance training in healthy adults : an exploratory research
Date of disclosure of the study information 2019/03/30
Last modified on 2017/12/10

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Basic information
Public title Effects of various balance training in healthy adults : an exploratory research
Acronym Effects of various balance training in healthy adults : an exploratory research
Scientific Title Effects of various balance training in healthy adults : an exploratory research
Scientific Title:Acronym Effects of various balance training in healthy adults : an exploratory research
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the effects of balance training and resistance training on postural stability in healthy volunteers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes index of postural stability
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 balance training on firm ground with eyes open
Interventions/Control_2 balance training on foam rubber with eyes open
Interventions/Control_3 balance training on firm ground with eyes closed
Interventions/Control_4 balance training on foam rubber with eyes closed
Interventions/Control_5 resistance training
Interventions/Control_6 control
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >
Gender Male and Female
Key inclusion criteria 1)Healthy volunteers can walk independently
2)Healthy volunteers can were obtained this study's consent
Key exclusion criteria 1)diabetes,
2)hypertension,
3)paralysis caused by central nervous system damage,
4)can't keep standing on foam rubber with eyes closed for 10 seconds
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hada Yasushi
Organization University of Tsukuba
Division name department of rehabilitation medicine
Zip code
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
TEL 029-853-3795
Email tsukuba.hosp.reha@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Ryotaro Ide
Organization University of Tsukuba hospital
Division name department of rehabilitation medicine
Zip code
Address 2-1-1 Amakubo, Tsukuba,Ibaraki
TEL 029-853-3795
Homepage URL
Email ryotaro-0076@umin.ac.jp

Sponsor
Institute University of Tsukuba hospital
Institute
Department

Funding Source
Organization nothing
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
2019 Year 03 Month 30 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
2017 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 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 12 Month 10 Day
Last modified on
2017 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034642

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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