UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063151 |
|---|---|
| Receipt number | R000072264 |
| Scientific Title | Effect of compression values in transtibial prosthetic sockets on socket interface pressure and comfort |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/10/02 15:58:05 |
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Basic information
Public title
Effect of compression values in transtibial prosthetic sockets on socket interface pressure and comfort
Acronym
Effect of compression values in transtibial prosthetic sockets on socket interface pressure and comfort
Scientific Title
Effect of compression values in transtibial prosthetic sockets on socket interface pressure and comfort
Scientific Title:Acronym
Effect of compression values in transtibial prosthetic sockets on socket interface pressure and comfort
Region
| Japan |
Condition
Condition
transtibial amputee
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For an amputee to walk comfortably with a prosthesis, the fit of the socket which houses the residual limb is crucial. There are currently no quantitative standards for adjusting parameters such as residual limb elongation and circumferential compression. Compression Value is CV during the design process instead these decisions largely rely on the experience of prosthetists. Consequently, issues such as instability due to shallow socket depth or excessive localized pressure can arise, leading to pain and poor fit. This study focuses on the interaction of "optimal CV values" tailored to the individual and aims to clarify the effects of residual limb elongation versus non-elongation on socket interface pressure distribution and Subjective Comfort Score. We believe that this research will establish fundamental data for developing quantitative standards for socket fit in CAD design, thereby providing significant benefits to both amputees and the medical professionals involved in their rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For transtibial amputees, two types of sockets, one extended and one nonextended based on CV values are fabricated. Pressure sensors are attached inside the sockets to measure internal pressure using a test prosthesis. Additionally, a socket comfort score chart is used to objectively evaluate the comfort of the socket fit. The activities performed consist of standing, marching in place, and walking.
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
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
This study compares the effects of combining a 10 mm distal end extension with the individual's optimal compression value (CV value) on reducing local peak pressures within the socket and improving pressure distribution based on Total Surface Bearing (TSB) theory and wearing comfort.
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
Healthy adults with no history of orthopedic or spinal disorders. Individuals with the cognitive ability to understand the purpose and content of the study.
Key exclusion criteria
Individuals with a history of orthopedic conditions who lack the cognitive ability to understand the purpose and content of the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Suda |
Organization
Niigata University of Health and Welfare
Division name
Dept. of Prosthetics, Orthotics and Assistive Technology
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-City 950-3198, Japan
TEL
0252574602
suda@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Suda |
Organization
Niigata University of Health and Welfare
Division name
Dept. of Prosthetics, Orthotics and Assistive Technology
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-City 950-3198, Japan
TEL
0252574602
Homepage URL
suda@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Hironori Suda
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-City 950-3198, Japan
Tel
0252574602
suda@nuhw.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
| 2026 | Year | 10 | Month | 02 | 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
| 2026 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 10 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072264
