Tokyo, May 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061597) titled 'Footwear Type Modulates Lower Limb Inter-Joint Coordination During Running: A Randomized Controlled Trial Comparing Barefoot, Minimalist, and Standard Shoes' on May 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Self funding
Condition:
Condition - one test
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Barefoot Condition
Interventions/Control_2 - Minimalist (Five Finger) Footwear Condition
Eligibility:
Age-lower limit - 18
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 Size - 150
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070478
Disclaimer: Curated by HT Syndication.