UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061597 |
|---|---|
| Receipt number | R000070478 |
| Scientific Title | Footwear Type Modulates Lower Limb Inter-Joint Coordination During Running: A Randomized Controlled Trial Comparing Barefoot, Minimalist, and Standard Shoes |
| Date of disclosure of the study information | 2026/05/27 |
| Last modified on | 2026/05/17 04:19:59 |
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Basic information
Public title
Footwear Type Modulates Lower Limb Inter-Joint Coordination During Running: A Randomized Controlled Trial Comparing Barefoot, Minimalist, and Standard Shoes
Acronym
Footwear Type Modulates Lower Limb Inter-Joint Coordination During Running: A Randomized Controlled Trial Comparing Barefoot, Minimalist, and Standard Shoes
Scientific Title
Footwear Type Modulates Lower Limb Inter-Joint Coordination During Running: A Randomized Controlled Trial Comparing Barefoot, Minimalist, and Standard Shoes
Scientific Title:Acronym
Footwear Type Modulates Lower Limb Inter-Joint Coordination During Running: A Randomized Controlled Trial Comparing Barefoot, Minimalist, and Standard Shoes
Region
| Asia(except Japan) |
Condition
Condition
one test
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this three arm randomized controlled trial was to investigate the acute effects of three different footwear conditions barefoot, minimalist (five finger) shoes, and standard cushioned running shoes on ankle-knee and knee hip joint coupling coordination during running in recreational runners. Specifically, the study aimed to determine whether minimalist footwear produces joint coupling patterns more similar to barefoot running compared with conventional running shoes, and to quantify the magnitude of differences in continuous relative phase angles across the stance phase of running at moderate and fast speeds.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
These primary outcomes were chosen because altered inter joint coupling patterns and abnormal coordinative variability have been linked to increased risk of running-related injuries, including patellofemoral pain, iliotibial band syndrome, and tibial stress fractures.
Key secondary outcomes
These secondary measures were selected to help explain potential changes in joint coupling by linking them to alterations in joint motion, foot strike strategy, and impact loading factors that are mechanistically associated with running-related injury risk and performance.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Barefoot Condition
Interventions/Control_2
Minimalist (Five Finger) Footwear Condition
Interventions/Control_3
Standard (Conventional) Running Shoes Condition
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male recreational runners aged years with a body mass index between who engaged in running at least twice per week for a minimum of six months prior to the study were eligible to participate. Participants were required to have no history of lower extremity musculoskeletal injury or surgery in the previous months, no neurological or cardiovascular conditions that could affect running gait, and no current pain or discomfort during running. All participants were required to demonstrate the ability to run comfortably at both speeds and to tolerate the testing protocol during the familiarization session.
Key exclusion criteria
Participants were excluded if they had any history of lower extremity musculoskeletal injury or surgery within the previous months, current lower limb pain or discomfort during running, neurological or vestibular disorders, cardiovascular conditions that could be aggravated by running, or any systemic disease affecting gait or balance. Individuals with a history of chronic ankle instability, patellofemoral pain syndrome, iliotibial band syndrome, or stress fractures in the past two years were also excluded. Participants who were unable to run comfortably at during the familiarization session, those with foot deformities or skin conditions that would prevent barefoot or minimalist shoe running, regular users of minimalist or five-finger shoes (more than once per week), and individuals with BMI outside the range of were not included in the study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hadi |
| Middle name | |
| Last name | Mohammad nia samakosh |
Organization
KHU
Division name
KHU
Zip code
4717647745
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
shahramsamakosh92@yahoo.com
Public contact
Name of contact person
| 1st name | Hadi |
| Middle name | |
| Last name | Mohammad nia samakosh |
Organization
Kharazmi university
Division name
KHU
Zip code
1491115719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
Homepage URL
shahramsamakosh92@yahoo.com
Sponsor or person
Institute
Self funding
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
phyical education
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
Tel
989336487376
a.mehmandoust@mail.sbu.ac.ir
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 | 05 | Month | 27 | 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 | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 14 | 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 | 05 | Month | 17 | Day |
Last modified on
| 2026 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070478
