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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035087
Receipt No. R000039998
Official scientific title of the study The study of lower extremity movement with ankle braces
Date of disclosure of the study information 2018/12/03
Last modified on 2018/11/30

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Basic information
Official scientific title of the study The study of lower extremity movement with ankle braces
Title of the study (Brief title) 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 Yukio Urabe
Organization Graduate school of Biomedical and Health Sciences, Hiroshima University
Division name Sports rehabilitation laboratory
Address 1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima-prefecture
TEL 082-257-5405
Email yurabe@hiroshima-u.ac.jp

Public contact
Name of contact person Shuhei Numano
Organization Graduate school of Biomedical and Health Sciences, Hiroshima University
Division name Sports rehabilitation laboratory
Address 1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima-prefecture
TEL 08029954320
Homepage URL
Email shuhei-numano@hiroshima-u.c.jp

Sponsor
Institute Hiroshima University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 03 Day
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 30 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039998

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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