UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058143 |
|---|---|
| Receipt number | R000066456 |
| Scientific Title | Establishment of an evaluation method for thigh soft tissue hardness - Examination of the establishment of an objective evaluation method using a tape measure and hardness meter - |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/10 17:36:04 |
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Basic information
Public title
Establishment of an evaluation method for thigh soft tissue hardness - Examination of the establishment of an objective evaluation method using a tape measure and hardness meter -
Acronym
Establishment of an evaluation method for thigh soft tissue hardness - Examination of the establishment of an objective evaluation method using a tape measure and hardness meter -
Scientific Title
Establishment of an evaluation method for thigh soft tissue hardness - Examination of the establishment of an objective evaluation method using a tape measure and hardness meter -
Scientific Title:Acronym
Establishment of an evaluation method for thigh soft tissue hardness - Examination of the establishment of an objective evaluation method using a tape measure and hardness meter -
Region
| Japan |
Condition
Condition
transfemoral amputee
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish soft tissue assessment of the thigh in transfemoral amputees and healthy controls.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation item will be the flexibility of the soft tissue in the thigh. Using a hardness meter and tape measure, the hardness of the soft tissue in the stump will be measured for both the amputated leg of the femoral amputee and the right leg of the healthy subject. The subjects will be asked to stand, and a comparison will be made of the soft tissue flexibility at two tape measure locations and 16 hardness meter locations.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The subject is asked to stand and a hardness tester is used to measure 16 points. A tape measure is also used to measure the circumference at two points and the value calculated by squeezing the circumference with the tape measure.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects with transfemoral amputation
Key exclusion criteria
History of musculoskeletal or central nervous system disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | eri |
| Middle name | |
| Last name | matsushima |
Organization
Niigata University of Health and Welfare
Division name
Health Science Major, Prosthetics and Orthotics Independent Living Major
Zip code
9503198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252574621
ham25003@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | eri |
| Middle name | |
| Last name | matsushima |
Organization
Niigata University of Health and Welfare
Division name
Health Science Major: Prosthetics and Orthotics for Independent Living
Zip code
9503198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252574621
Homepage URL
ham25003@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
0252674621
ham25003@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
| 2025 | Year | 06 | Month | 30 | 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
| 2025 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066456
