UMIN-CTR Clinical Trial

Basic information
Public title	A study to examine the correlation between foot information and gait
Acronym	A study to examine the correlation between foot information and gait
Scientific Title	A study to examine the correlation between foot information and gait
Scientific Title:Acronym	A study to examine the correlation between foot information and gait
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine whether there is a correlation between foot and gait data for adult men and women.
Basic objectives2	Others
Basic objectives -Others	Correlation between foot information and gait
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between foot information and gait
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy male and female subjects who are between 20 and 65 years of age from the time consent is obtained to the end of the study. (2) Subjects who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a good understanding of the purpose and content of the study, and who have agreed to participate in the study in writing.
Key exclusion criteria	(1) Pregnant (including possibly pregnant) or lactating female (2) Systolic blood pressure less than 90 mmHg at the most recent physical examination. (3) Subjects with heart, liver, or kidney disease (including cases where the disease is a complication of other diseases) (4) Subjects with a history of cardiovascular disease (5) Subjects who have diabetes (*Criteria: According to the diagnostic criteria established by the Japan Diabetes Society) (6) Subjects who are missing a foot or a part of the foot such as a toe or heel, and are unable to ground the entire sole to the surface of the measuring device. (7) Subjects who cannot walk independently (those who use walking aids such as "canes," "nursing care walkers," "wheelbarrows for the elderly," and "walking carts" on a daily basis). (8) Subjects who are allergic to the materials and components of the devices and measuring instruments used in this test. (9) Subjects who are participating in other clinical studies, or who finished clinical study within the last 4 weeks. (10) Subjects who are injured, dizzy, or otherwise unable to maintain daily standing or walking on the day of the examination as determined by the physician assigned to the case. (11) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	550

Research contact person
Name of lead principal investigator	1st name Mitsuhiro Middle name Last name Zeida
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	080-2546-4385
Email	Mitsuhiro_Zeida@suntory.co.jp

Public contact
Name of contact person	1st name Junki Middle name Last name Yamamura
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0474
Homepage URL
Email	Junki_Yamamura@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Macromill, Inc. Healthcare Systems Co., Ltd. Data Select Co. Ltd
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel	03-6809-2722
Email	soumu@hc-sys.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 11 Month 14 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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date	2022 Year 11 Month 11 Day
Last follow-up date	2022 Year 12 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Correlation between foot information and gait

Management information
Registered date	2022 Year 11 Month 13 Day
Last modified on	2022 Year 11 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056343