UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035390
Receipt number 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 2020/01/06 09:31:04

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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 Kumiko
Middle name
Last name ONO

Organization

Kobe University

Division name

Graduate school of health sciences

Zip code

654-0142

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 Kumiko
Middle name
Last name ONO

Organization

Kobe University

Division name

Graduate school of health sciences

Zip code

654-0142

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 or person

Institute

Kobe University

Institute

Department

Personal name



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

Kobe University Graduate School of Health Sciences, Health Sciences Ethical Committee

Address

7-10-2 Tomogaoka, Suma, Kobe-shi, Hyogo

Tel

078-792-2555

Email

syomu2@ams.kobe-u.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



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

Completed

Date of protocol fixation

2018 Year 10 Month 16 Day

Date of IRB

2018 Year 12 Month 25 Day

Anticipated trial start date

2018 Year 12 Month 28 Day

Last follow-up date

2019 Year 12 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

2018 Year 12 Month 28 Day

Last modified on

2020 Year 01 Month 06 Day



Link to view the page

Value
https://center6.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