UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055592 |
|---|---|
| Receipt number | R000063527 |
| Scientific Title | Effects of prosthetic socket fit and alignment adjustments on intra-socket pressure and kinematic and kinetic parameters during gait in trans tibial amputees. |
| Date of disclosure of the study information | 2024/09/25 |
| Last modified on | 2025/09/24 09:22:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of prosthetic socket fit and alignment adjustments on intra-socket pressure and gait motion.
Acronym
Pressure Measurement and Motion Analysis Testing
Scientific Title
Effects of prosthetic socket fit and alignment adjustments on intra-socket pressure and kinematic and kinetic parameters during gait in trans tibial amputees.
Scientific Title:Acronym
Pressure Measurement and Motion Analysis Testing
Region
| Japan |
Condition
Condition
Trans tibial amputee
Classification by specialty
| Cardiology | Surgery in general | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For an amputee to walk with a prosthetic limb, socket fit of the part where the amputated foot (stump) is inserted and alignment adjustment to adjust the attachment angle and position of each part are important, but there is no indicator to evaluate whether these are properly adjusted, and the decision is left to the experience of the prosthetist. As a result, there are cases in which amputees have difficulty walking due to mismatched socket geometry or poor adjustment of disconnection and alignment. Therefore, this study will elucidate the ideal pressure in the socket. In addition, the purpose of this study is to clarify the changes in pressure in the socket and its effect on the walking motion when the alignment is poorly adjusted. This will be of great significance to the subject and to the medical professionals involved in rehabilitation.
Basic objectives2
Others
Basic objectives -Others
A study to evaluate the effectiveness of prosthetist intervention
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Evaluate the pressure in the prosthetic socket. The timing of the evaluation should be before and after the prosthetist performs the alignment intervention.
Key secondary outcomes
Evaluate kinematic and kinematic parameters during gait. The timing of the evaluation should be before and after the prosthetist performs the alignment intervention.
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
| Device,equipment |
Interventions/Control_1
The prosthetist adjusts the socket alignment for the individual amputee's prosthetic limb.
There shall be a total of eight conditions: socket adduction angle (+/-), flexion angle (+/-), internal/external position (+/-), and anteroposterior position (+/-).
Experimental measurements will be taken after the intervention and returned to normal alignment after completion.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Lower leg amputees who can walk unassisted with a prosthesis in daily life.
Key exclusion criteria
Those with orthopedic disease in the lower limb on the healthy side, those with bilateral amputation, and those who have difficulty walking with a prosthetic limb.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Go |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation Department of Prosthetics & Orthotics and Assistive Technology
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL
025-257-4454
go@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Go |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation Department of Prosthetics & Orthotics and Assistive Technology
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL
025-257-4454
Homepage URL
go@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
Non profit foundation
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 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
025-257-4454
go@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
新潟医療福祉大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 25 | 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
| 2024 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 09 | Month | 23 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063527
