UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062675 |
|---|---|
| Receipt number | R000071751 |
| Scientific Title | The Effects of Running Shoes with Different Midsole Stiffness and Cushioning Characteristics on Lower Limb Joint Coordination and Centre of Gravity Dynamics During Constant-Speed Running on Field |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/25 00:34:20 |
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Basic information
Public title
The Effects of Max-cushion Running Shoes on Lower Limb Joint Coordination and Body Centre of Gravity Dynamics During Running
Acronym
The Effects of Max-cushion Running Shoes on Lower Limb Joints and Centre of Gravity Dynamics
Scientific Title
The Effects of Running Shoes with Different Midsole Stiffness and Cushioning Characteristics on Lower Limb Joint Coordination and Centre of Gravity Dynamics During Constant-Speed Running on Field
Scientific Title:Acronym
The Effects of High-Performance Running Shoes on Lower Limb Joints and Centre of Gravity Dynamics During Running
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate, with the high ecological validity unique to running on land, how artificial shoe features alter a runner's natural anatomical and coordinative movement control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Running economy (oxygen consumption) during constant-velocity treadmill running
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Advanced shoe group (Intervention group): Participants perform running trials wearing the advanced carbon-plated running shoes (Adios Pro 4). The protocol includes a 5-minute treadmill run at 95% of individual VT speed (Session 2) and overground running on force plates for 5 successful trials at the identical speed (Session 3).
Interventions/Control_2
Standard shoe group (Control group): Participants perform running trials under the identical protocol (treadmill and overground runs) as Intervention 1, wearing the standard lightweight running shoes without a carbon plate (Adizero RC).
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
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Participants who meet all of the following criteria will be included: 1. Male runners aged 18 to 22 years who belong to the Niigata University of Health and Welfare track and field team (long-distance block). 2. Individuals who have engaged in regular running training at least 3 days per week consistently for the past 3 months. 3. Individuals with a personal best time under 25 minutes for a 5000-meter run.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded: 1. Individuals with a history of acute or chronic musculoskeletal or orthopedic injuries/pain of the lower extremities within the past 3 months that prevented them from running. 2. Individuals with lower limb alignment abnormalities (e.g., severe pes planus/flat feet) that require the constant use of orthotic insoles during daily activities or sports. 3. Individuals with any pre-existing respiratory, cardiovascular, or neurological diseases or disorders.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Shimojo |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences
Zip code
9503198
Address
1398, Shimami-cho, Kita-ku, Niigata city, Niigata
TEL
0252574669
shimojo@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Shimojo |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences
Zip code
9503198
Address
1398, Shimami-cho, Kita-ku, Niigata city, Niigata
TEL
0252574669
Homepage URL
shimojo@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
Institutional Review Board Office, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, Japan
Tel
025-257-4455
rinri@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 | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | 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 | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071751
