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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035390
Receipt No. R000040322
Scientific Title The optimal time for balance exercise that affects Star excursion balance test; SEBT and toe grip strength
Date of disclosure of the study information 2018/12/28
Last modified on 2019/02/27

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Basic information
Public title The optimal time for balance exercise that affects Star excursion balance test; SEBT and toe grip strength
Acronym The optimal time for balance exercise that affects Star excursion balance test; SEBT and toe grip strength
Scientific Title The optimal time for balance exercise that affects Star excursion balance test; SEBT and toe grip strength
Scientific Title:Acronym The optimal time for balance exercise that affects Star excursion balance test; SEBT and toe grip strength
Region
Japan

Condition
Condition healthy young adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the optimal time for balance exercise that affects SEBT and toe grip strength
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SEBT
toe grip strength
Key secondary outcomes subjective fatigue level of lower limb

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 7
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Measurement of SEBT and toe grip strength > Balance exercise A > Measurement of subjective fatigue level of lower limb > Measurement of SEBT and toe grip
Interventions/Control_2 Measurement of SEBT and toe grip strength > Balance exercise B > Measurement of subjective fatigue level of lower limb > Measurement of SEBT and toe grip
Interventions/Control_3 Measurement of SEBT and toe grip strength > Balance exercise C > Measurement of subjective fatigue level of lower limb > Measurement of SEBT and toe grip
Interventions/Control_4 Measurement of SEBT and toe grip strength > Balance exercise D > Measurement of subjective fatigue level of lower limb > Measurement of SEBT and toe grip
Interventions/Control_5 Measurement of SEBT and toe grip strength > Balance exercise E > Measurement of subjective fatigue level of lower limb > Measurement of SEBT and toe grip
Interventions/Control_6 Measurement of SEBT and toe grip strength > Balance exercise F > Measurement of subjective fatigue level of lower limb > Measurement of SEBT and toe grip
Interventions/Control_7 Measurement of SEBT and toe grip strength > Balance exercise G > Measurement of subjective fatigue level of lower limb > Measurement of SEBT and toe grip
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria Healthy young adults who have given written informed consent
Key exclusion criteria injuries of ankle joint in the past two years
dizziness
inner ear disorder
neurological disorder
motor disorder
medical history of consciousness disorder
vision disorder
disorder of balance ability
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kumiko ONO
Organization Kobe University
Division name Graduate school of health sciences
Zip code
Address 7-10-2 Tomogaoka, Suma-ku, Kobe-shi, Hyogo, JAPAN
TEL 078-796-4582
Email onoku@tiger.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kumiko ONO
Organization Kobe University
Division name Graduate school of health sciences
Zip code
Address 7-10-2 Tomogaoka, Suma-ku, Kobe-shi, Hyogo, JAPAN
TEL 078-796-4582
Homepage URL
Email onoku@tiger.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
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
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
2018 Year 12 Month 28 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 28 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
2018 Year 12 Month 28 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040322

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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