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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047754
Receipt No. R000054440
Scientific Title Effect of insoles created using digital tools on static standing posture and level walking
Date of disclosure of the study information 2022/05/16
Last modified on 2022/05/14

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Basic information
Public title Effect of insoles created using digital tools on static standing posture and level walking
Acronym Effect of insoles on static standing posture and level walking
Scientific Title Effect of insoles created using digital tools on static standing posture and level walking
Scientific Title:Acronym Effect of insoles on static standing posture and level walking
Region
Japan

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

Objectives
Narrative objectives1 Kinematically and kinematically clarify the effects of insoles created using digital tools on static standing posture and walking.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ground reaction force, Center of pressure, Joint angles and moments, and Spatiotemporal gait parameters while using the insole.
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 Use of insoles made with a 3D printer
Interventions/Control_2 Use of manually made insoles
Interventions/Control_3 No insoles used
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
25 years-old >
Gender Male and Female
Key inclusion criteria Foot size is 22 cm or more and 26 cm or less. Those with a misaligned foot.
Key exclusion criteria Those with large laterality or with claudication when walking.
Those with difficulty to maintain a standing position for 30 seconds or more.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name Junji
Middle name
Last name Katsuhira
Organization Toyo University
Division name Faculty of Life Design
Zip code 115-8650
Address Akabanedai1-7-11, Kitaku, Tokyo
TEL 03-5924-2267
Email katsuhira@toyo.jp

Public contact
Name of contact person
1st name Junji
Middle name
Last name Katsuhira
Organization Toyo University
Division name Faculty of Life Design
Zip code 115-8650
Address Akabanedai1-7-11, Kitaku, Tokyo
TEL 03-5924-2267
Homepage URL
Email katsuhira@toyo.jp

Sponsor
Institute Toyo University
Institute
Department

Funding Source
Organization Toyo University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Toyo University
Address Akabanedai1-7-11, Kitaku, Tokyo
Tel 03-5924-2148
Email ml-akj@toyo.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 05 Month 16 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 04 Month 26 Day
Date of IRB
2022 Year 04 Month 26 Day
Anticipated trial start date
2022 Year 05 Month 16 Day
Last follow-up date
2023 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 05 Month 14 Day
Last modified on
2022 Year 05 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054440

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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