UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049487 |
|---|---|
| Receipt number | R000056343 |
| Scientific Title | A study to examine the correlation between foot information and gait |
| Date of disclosure of the study information | 2022/11/14 |
| Last modified on | 2022/11/13 19:28:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Junki_Yamamura@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056343
