UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030334
Receipt number 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 16:48:39

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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 or person

Institute

University of Tsukuba hospital

Institute

Department

Personal name



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

Value
https://center6.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