UMIN-CTR Clinical Trial

Basic information
Public title	About the effect of hallux extension dynamic orthotic device on attitude control.
Acronym	About the effect of hallux extension dynamic orthotic device on attitude control.
Scientific Title	About the effect of hallux extension dynamic orthotic device on attitude control.
Scientific Title:Acronym	About the effect of hallux extension dynamic orthotic device on attitude control.
Region	Japan

Condition
Condition	Healthy woman
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effect of wearing a hallux dynamic extension device on postural control using kinematic, kinematic and physiological methods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Physical exercise data in static standing and disturbed standing 2. Physical exercise data in the movement to start walking 3. Physical exercise data with continuous wearing for a certain period of time 4. Immediateness of reaction by wearing hallux orthotic device 5. Sustainability of reaction by wearing hallux orthotic device
Key secondary outcomes	1. Adverse events when wearing hallux orthotics 2.EMG data when wearing a hallux orthotic device 3. Relationship with basic physical function

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Hallux extension traction device with foot orthotic device.
Interventions/Control_2
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	19 years-old <=
Age-upper limit	77 years-old >=
Gender	Female
Key inclusion criteria	1. The subjects of the study are healthy women, both young and old. 2. Those who do not have musculoskeletal disorders and, in principle, have not undergone orthopedic surgery in the past year.
Key exclusion criteria	We decided to exclude those who have the following conditions that may affect the results of attitude control experiments. 1. Those who have difficulty in understanding verbal instructions and have low communication 2. Persons with internal medicine / circulatory system diseases, etc., who are judged to have low responsiveness to continuous measurement 3. Those who have surgical procedures or joint deformities with changes in anatomical structure
Target sample size	51

Research contact person
Name of lead principal investigator	1st name Keiichiro Middle name Last name Saito
Organization	Kyoto Tachibana University
Division name	Faculty of Health Sciences
Zip code	607-8175
Address	34 Yamada-cho Oyake Yamashina-ku Kyoto 607-8175 Japan
TEL	075-571-1111
Email	Saito-K@tachibana-u.ac.jp

Public contact
Name of contact person	1st name Keiichiro Middle name Last name Saito
Organization	Kyoto Tachibana University
Division name	Faculty of Health Sciences
Zip code	607-8175
Address	34 Yamada-cho Oyake Yamashina-ku Kyoto 607-8175 Japan
TEL	075-571-1111
Homepage URL
Email	saito-k@tachibana-u.ac.jp

Sponsor
Institute	Kyoto Tachibana University
Institute
Department

Funding Source
Organization	Kyoto Tachibana University
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	Kyoto Tachibana University
Address	34 Yamada-cho Oyake Yamashina-ku Kyoto 607-8175 Japan
Tel	075-571-1111
Email	saito-k@tachibana-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	2022 Year 04 Month 17 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	51
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	2014 Year 08 Month 24 Day
Date of IRB	2014 Year 08 Month 25 Day
Anticipated trial start date	2022 Year 04 Month 17 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 16 Day
Last modified on	2022 Year 04 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054176