UMIN-CTR Clinical Trial

Basic information
Public title	The effect of bandage socks on the dynamic stability of the ankle joint.
Acronym	Dynamic stability of the ankle joint by bandage socks
Scientific Title	The effect of bandage socks on the dynamic stability of the ankle joint.
Scientific Title:Acronym	Dynamic stability of the ankle joint by bandage socks
Region	Japan

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

Objectives
Narrative objectives1	Bandage socks are supposed to limit the range of motion of the ankle joints. How they affect the dynamic stability of the ankle joint, one of the major risk factors of ankle joint injury, is not clarified. The purpose of the study is to elucidate the effect of wearing bandage socks on the dynamic stability of ankle joints.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dynamic stability will be evaluated from ground reaction force measurement during 8 directional hopping movements.
Key secondary outcomes	Static stability will be evaluated from COP fluctuation during standing on a forceplate.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Wearing bandage socks for 1 month more than 8 hours/day.
Interventions/Control_2	No treatment control
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	18 years-old <=
Age-upper limit	24 years-old >=
Gender	Male and Female
Key inclusion criteria	Shoe size between 22.5 cm and 28 cm Having experiences in a club-sports activity.
Key exclusion criteria	1.Chronic ankle instability 2.Surgical history of lower limb neuromusculoskeletal system 3.Malalignment of lower limb or hip due to fracture or malformation which requires surgical intervention 4. Acute injury of lower limbs or hip that prohibited participation in any exercise more than a week within 3 months before the participation in the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Ryoichi Middle name Last name Nagatomi
Organization	Tohoku Univerisity
Division name	Graduate School of Biomedical Engineering
Zip code	980-8575
Address	Seiryo-cho 2-1, Aoba-ku, Sendai
TEL	022-717-8586
Email	nagatomi@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Ryoichi Middle name Last name Nagatomi
Organization	Tohoku Univerisity
Division name	Graduate School of Biomedical Engineering
Zip code	980-8575
Address	Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
TEL	022-717-8586
Homepage URL
Email	nagatomi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Graduate School of Medicine
Address	Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	2020 Year 12 Month 05 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
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 12 Month 05 Day
Date of IRB	2020 Year 12 Month 05 Day
Anticipated trial start date	2020 Year 12 Month 07 Day
Last follow-up date	2021 Year 01 Month 15 Day
Date of closure to data entry	2021 Year 01 Month 15 Day
Date trial data considered complete	2021 Year 01 Month 15 Day
Date analysis concluded	2021 Year 01 Month 25 Day

Other
Other related information

Management information
Registered date	2020 Year 12 Month 05 Day
Last modified on	2021 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048676