UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059421 |
|---|---|
| Receipt number | R000067957 |
| Scientific Title | Applied research for shoes outsole adjustment by foot pressure measurement during walking with mock prosthetic leg |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/10/15 15:15:01 |
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Basic information
Public title
Foot pressure measurement during walking with mock prosthetic leg
Acronym
Foot pressure measurement during walking with mock prosthetic leg
Scientific Title
Applied research for shoes outsole adjustment by foot pressure measurement during walking with mock prosthetic leg
Scientific Title:Acronym
Applied research for shoes outsole adjustment by foot pressure measurement during walking with mock prosthetic leg
Region
| Japan |
Condition
Condition
one leg amputation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Measuring and comparing foot pressure during walking with mock prothesis and intact
2. Constructing shoes outsole for enhancing stability during walking, and verifying its effect by comparing foot pressure with and without mock prothesis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
foot pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1- Normal walking
2- Walking with mock prothesis
3- Walking with mock prothesis attached with constructed shoes outsole
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy people who have no problems walking daily
Key exclusion criteria
Having a medical condition that makes it difficult to normal walk
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Kaneda |
Organization
Chiba Institute of Technology
Division name
Faculty of Advanced Engineering
Zip code
275-0023
Address
Shibazono 2-1-1, Narashino-City, Chiba Pref., Japan
TEL
047-454-9935
koichi.kaneda@p.chibakoudai.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Kaneda |
Organization
Chiba Institute of Technology
Division name
Faculty of Advanced Engineering
Zip code
275-0023
Address
Shibazono 2-1-1, Narashino-City, Chiba Pref., Japan
TEL
047-454-9935
Homepage URL
koichi.kaneda@p.chibakoudai.jp
Sponsor or person
Institute
Chiba Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Chiba Institute of Technology
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
Human Ethics Committee at Chiba Institute of Technology
Address
Tsudanuma 2-17-1, Narashino-City, Chiba-Pref., Japan
Tel
047-478-0325
kenkyushien-stf@it-chiba.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
| 2025 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067957
