UMIN-CTR Clinical Trial

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
Email	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
Email	shuhei-numano@hiroshima-u.ac.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)

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039998