UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058007 |
|---|---|
| Receipt number | R000066309 |
| Scientific Title | Acceleration evaluation during prosthetic leg running |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/05/29 10:29:45 |
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Basic information
Public title
The effect of spike sole shape on the acceleration of running prosthetic legs
Acronym
The effect of spike sole shape on the acceleration of running prosthetic legs
Scientific Title
Acceleration evaluation during prosthetic leg running
Scientific Title:Acronym
Acceleration evaluation during prosthetic leg running
Region
| Japan |
Condition
Condition
lower limb amputation
Classification by specialty
| Surgery in general | Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Running prosthetic legs use specialized prosthetic foot components called blades, which are made of carbon fiber plates that flex and return to their original shape, generating propulsive force. In track and field events for able-bodied athletes, it has been established that the shape of the spike sole and the thickness of the outsole affect running performance. Therefore, this study aims to clarify whether the shape and thickness of the spike sole also affect running performance in running prosthetic legs, similar to able-bodied athletes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measure the forward and backward acceleration, vertical acceleration, running speed, and running pitch of the swing phase for each spike sole condition. There are two spike sole conditions: normal sole and thick sole.
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Running with thick-soled prosthetic legs for lower limb amputees.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Lower limb amputees with experience running with prosthetic legs
Key exclusion criteria
Both lower limbs amputated, history of orthopedic surgery in the healthy lower limb, unable to walk 50 meters due to physical limitations
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
950-3198
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
950-3198
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
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 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
0252574454
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
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | 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 | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066309
