Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062812) titled 'Effects of shoe height on the opposite side on energy expenditure during walking with a leg brace' on Sept. 3.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to investigate the effects of different contralateral shoe lift heights on oxygen consumption during walking with a knee-ankle-foot orthosis (KAFO) in healthy adults. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Walking without a knee-ankle-foot orthosis (KAFO) or shoe lift. For respiratory gas analysis, participants walk on a treadmill for 6 minutes at the predetermined comfortable walking speed. For three-dimensional motion analysis, participants walk along an approximately 6-m walkway at a comfortable walking speed. Interventions/Control_2 - Walking with a knee-ankle-foot orthosis (KAFO) and without a shoe lift on the contralateral side (0-cm condition). For respiratory gas analysis, participants walk on a treadmill for 6 minutes at the predetermined comfortable walking speed. For three-dimensional motion analysis, participants walk along an approximately 6-m walkway at a comfortable walking speed.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Healthy adults aged 18 years or older 2.Individuals who have no difficulty walking in daily life and are able to walk independently without assistive devices 3.Individuals without apparent orthopedic or neurological disorders of the lower limbs or trunk that may affect walking 4.Individuals who have received and understood a sufficient explanation of the purpose and procedures of the study and provided written informed consent Key exclusion criteria - 1.Individuals with a history of lower-limb fracture or surgery that may affect joint range of motion, muscle strength, or gait pattern 2.Individuals with brain or spinal cord disorders, peripheral neuropathy, balance disorders, or other conditions that may affect the safety or stability of walking 3.Individuals with hypertension, ischemic heart disease, asthma, or other conditions that may pose a health risk during exercise testing or respiratory gas analysis 4.Individuals with apparent lower-limb deformity or a leg length discrepancy of 1.0 cm or greater 5.Individuals with wounds, skin disorders, inflammation, or pain at the sites of contact with the knee-ankle-foot orthosis, for whom orthosis use may worsen symptoms Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 21 Day Date of IRB - 2026 Year 08 Month 27 Day Anticipated trial start date - 2026 Year 09 Month 07 Day Last follow-up date - 2027 Year 03 Month 10 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071868

Disclaimer: Curated by HT Syndication.