Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058257) titled 'Biomechanical and Foot Function Effects of Different 3D-Printed Foot Orthoses Materials in Adults with Flexible Flatfoot' on July 22.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Niigata University of Health and Welfare
Condition:
Condition - flat foot
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study investigates the effects of two different 3D-printed insole materials on medial longitudinal arch support and hindfoot alignment in adults with flexible flatfoot. We will examine how varying speeds during walking and running tasks influence the therapeutic efficacy of these insoles. The research aims to explore the effectiveness of 3D printing materials in personalized flatfoot management.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Insoles Made From a Single Material
Interventions/Control_2 - Insoles made from different materials
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Individuals with a navicular drop exceeding 10 mm and a Foot Posture Index score of 6 or higher
Key exclusion criteria - 1. History of foot or ankle surgery.
2. Foot deformity or leg length discrepancy exceeding 1 cm.
3. Presence of musculoskeletal disorders, neurological conditions, or peripheral neuropathy that may affect gait ability.
4. Experience with customized insoles within the past year.
Target Size - 32
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 10 Day
Anticipated trial start date - 2025 Year 07 Month 10 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066594
Disclaimer: Curated by HT Syndication.
