UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035087 |
|---|---|
| Receipt number | R000039998 |
| Scientific Title | The study of lower extremity movement with ankle braces |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2019/10/10 20:42:02 |
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Basic information
Public title
The study of lower extremity movement with ankle braces
Acronym
The study of lower extremity movement with ankle braces
Scientific Title
The study of lower extremity movement with ankle braces
Scientific Title:Acronym
The study of lower extremity movement with ankle braces
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is to clarify the effect of the ankle brace used after the ankle sprain on the lower extremity joint movement during the landing motion in the anterior and lateral directions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
The joint angle of the lower limbs during the landing motion is evaluated using a three-dimensional motion analysis device (VICON 612, Oxford).
Measurement is carried out until three successive trials are recorded, and the average value of three times is used as a representative value of the research subject for analysis.
[Setting rationale]
In this study, in order to study the influence of the use of ankle orthosis on knee joint movement, it is necessary to calculate the joint angle of the lower limb and use it for analysis
Key secondary outcomes
The ground reaction force
By evaluating the floor reaction force component, we analyze the impact applied to the joint. The average value of the three measured data is used as a representative value for analysis.
[Setting rationale]
The floor reaction force component reflects the strength of energy generated at the time of landing, the three-dimensional direction in which the energy works, and the temporal element, thereby analyzing the floor reaction force component, whereby the trauma other than the joint angle. Because it is possible to consider the risk of disability.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
NB (No Brace) condition to perform task operation with bare feet without using the brace
Interventions/Control_2
SB (Soft Brace) condition using biped foot ankle bracelet (FA-1 software support, Japan SIGMAX)
Interventions/Control_3
Condition for ankle-foot SRB (Semi-Rigid Brace, A-1 semi-rigid support, Japan SIGMAX) Condition
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Male and female employees aged 20 to over 30 who are enrolled in Hiroshima University at the time of acquisition.
Persons who have exercise habits at the recreation level.
A Person who obtains consent in writing on the participation of this research.
Key exclusion criteria
A person with a history of ankle sprain
Persons who have orthopedic diseases in lower limbs and trunk
Persons who have a history of operation in the lower limbs (excluding skin injuries)
Research staff and research subjects are in a relationship between teachers and students, and students take lectures of research staff
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Urabe |
Organization
Graduate school of Biomedical and Health Sciences, Hiroshima University
Division name
Sports rehabilitation laboratory
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima-prefecture
TEL
082-257-5405
yurabe@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Numano |
Organization
Graduate school of Biomedical and Health Sciences, Hiroshima University
Division name
Sports rehabilitation laboratory
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima-prefecture
TEL
08029954320
Homepage URL
shuhei-numano@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Self-sourcing
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
Tel
082-257-1551
iryo-seisaku@office.hiroshima-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 | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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 | 12 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039998
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| Registered date | File name |
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