UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047754 |
|---|---|
| Receipt number | 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 | 2023/04/06 13:57:01 |
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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
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
katsuhira@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054440
