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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046141
Receipt No. R000046062
Scientific Title A Study of the Relationship between Balance Training and shift the Center of Gravity
Date of disclosure of the study information 2021/11/24
Last modified on 2021/11/22

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Basic information
Public title A Study of the Relationship between Balance Training and shift the Center of Gravity
Acronym A Study of the Relationship between Balance Training and shift the Center of Gravity
Scientific Title A Study of the Relationship between Balance Training and shift the Center of Gravity
Scientific Title:Acronym A Study of the Relationship between Balance Training and shift the Center of Gravity
Region
Japan

Condition
Condition healthy people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to verify the relationship between balance training and shift of the center of gravity, and clarify the fall prevention mechanism of balance training by computer simulation program.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Variable of Center of Gravity during balance training and walking
Key secondary outcomes electromyography of low extremities,area of postural sway,Locus Length Per Unit Area,Berg Balance Scale,Timed Up and Go Test,One-leg standing time,muscle strength of ankle joint,10 meter walking time and speed,Threshold of Fall.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 balance training
Using equipment:balance training equipment(Cotoho Corporation)
2 sets of Twice a week for 4 weeks
Interventions/Control_2 walking training.
2 sets of Twice a week for 4 weeks
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Healthy people of the daily living independent
Person who can walk 10m.
Key exclusion criteria Those who are prohibited from exercise by the doctor.
A history of acute illness requiring hospitalization within the past 3 months.
Dementia.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoshio
Middle name
Last name Takano
Organization International University Health and Welfare
Division name Department of Physical Therapy School of Health Sciences at Fukuoka
Zip code 8318501
Address 137-1 Enokizu, Okawa, Fukuoka JAPAN
TEL 0944892000
Email y-takano@iuhw.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Takano
Organization International University Health and Welfare
Division name Department of Physical Therapy School of Health Sciences at Fukuoka
Zip code 8318501
Address 137-1 Enokizu, Okawa, Fukuoka JAPAN
TEL 0944892000
Homepage URL
Email y-takano@iuhw.ac.jp

Sponsor
Institute International University Health and Welfare
Institute
Department

Funding Source
Organization Cotoho Corpolation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization International University of Health and welfare
Address 137-1 Enokizu, Okawa, Fukuoka JAPAN
Tel 0944892000
Email y-takano@iuhw.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 久留米大学

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 24 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 20
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 No longer recruiting
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
2020 Year 07 Month 01 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2023 Year 03 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
2021 Year 11 Month 22 Day
Last modified on
2021 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046062

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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