UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046141 |
|---|---|
| Receipt number | 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 | 2023/05/25 19:02:52 |
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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
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
y-takano@iuhw.ac.jp
Sponsor or person
Institute
International University Health and Welfare
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 22 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046062
