Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061739) titled 'The Effect of a Six-Week Corrective Exercise Program on Plantar Pressure Distribution and Dynamic Balance in Young Male Soccer Players with Flexible Pes Planus' on June 16.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - self funding
Condition:
Condition - pre-post
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This study is a two-arm, parallel-group, randomized controlled trial designed to evaluate the effect of a six-week corrective exercise program on plantar pressure distribution and dynamic balance in young male soccer players with flexible flatfoot. Participants (n=40) aged 10 to 15 years were randomly assigned to either a corrective exercise group (n=20) or a control group (n=20). The primary outcomes are peak plantar pressure (kPa) in the forefoot and heel regions and the Center of Pressure Excursion Index (CPEI). The secondary outcome is dynamic balance measured by the Y Balance Test composite score. All outcomes were assessed at baseline and immediately post-intervention (6 weeks).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants in the experimental group performed a six week corrective exercise program
Interventions/Control_2 - Participants in the control group
Eligibility:
Age-lower limit - 10
years-old
=
Gender - Male
Key inclusion criteria - Male sex
Age 10 to 15 years
Active participation in a football club or school team for at least two years, with a minimum of three training sessions per week
Confirmed flexible flatfoot based on both.
Key exclusion criteria - Presence of systemic or neuromuscular disorders (cerebral palsy, spina bifida, peripheral neuropathy, vestibular disorders, rheumatoid arthritis, lupus, diabetes mellitus)
History of severe lower extremity injury within the past year (fracture) or within the past two years (anterior cruciate ligament rupture, meniscus tear, ankle dislocation)
Obvious lower limb deformities such as cavus foot, knee varus valgus (abnormal Q angle), or leg length discrepancy greater than cm confirmed by an orthopedic specialist
Limited ankle dorsiflexion range of motion (less than with knee fully extended).
Target Size - 42
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 03 Day
Date of IRB - 2026 Year 04 Month 01 Day
Anticipated trial start date - 2026 Year 05 Month 01 Day
Last follow-up date - 2026 Year 06 Month 13 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070657
Disclaimer: Curated by HT Syndication.