UMIN-CTR Clinical Trial

Basic information
Public title	The effect of insole insertion on the dynamic stability of young healthy subjects
Acronym	The effect of insole insertion on dynamic stability
Scientific Title	The effect of insole insertion on the dynamic stability of young healthy subjects
Scientific Title:Acronym	The effect of insole insertion on dynamic stability
Region	Japan

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

Objectives
Narrative objectives1	To clarify the long term effect of plantar insole usage on dynamic stability of young healthy subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	dynamic stability after 1 month or 2 month of insole usage
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
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	Treatment
Type of intervention	Other
Interventions/Control_1	1-month insole usage
Interventions/Control_2	2-months insole usage
Interventions/Control_3	control (no insole usage)
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	24 years-old >=
Gender	Male and Female
Key inclusion criteria	shoe size between 23cm and 28 cm experience of regular club sports activity
Key exclusion criteria	low dynamic stability fulfilling chronic ankle instability criteria
Target sample size	60

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

Sponsor
Institute	Tohoku University Graduate School of Biomedical Engineering
Institute
Department

Funding Source
Organization	Tohoku University Graduate School of Biomedical Engineering
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	IRB Tohoku University School of Medicine
Address	Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
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	2019 Year 02 Month 25 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	18
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	2019 Year 02 Month 21 Day
Date of IRB	2019 Year 02 Month 28 Day
Anticipated trial start date	2019 Year 03 Month 10 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry	2019 Year 11 Month 15 Day
Date trial data considered complete	2019 Year 11 Month 30 Day
Date analysis concluded	2020 Year 01 Month 05 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 25 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041013