Tokyo, Jan. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060453) titled 'Analysis of lower limb muscle oxygenation kinetics during upper limb exercise in wheelchair users' on Jan. 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Fukushima Medical University

Condition: Condition - Spinal cord injury, Spina bifida, Lower limb amputation, Healthy participants Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to elucidate the characteristics of circulatory and metabolic responses in relation to impairment type and neurological level in wheelchair users (specifically individuals with spinal cord injury, spina bifida, and lower limb amputation) by measuring lower limb muscle oxygenation kinetics during upper limb exercise using NIRS. Basic objectives2 - Bio-equivalence

Intervention: Interventions/Control_1 - Cardiopulmonary exercise testing Interventions/Control_2 - Wheelchair propulsion exercise

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - Wheelchair User Group Adult males who are habitual wheelchair users due to conditions such as spinal cord injury (cervical or thoracolumbar), spina bifida, or lower limb amputation. Individuals capable of safely performing voluntary exercise using an upper limb ergometer. Individuals who demonstrated a full understanding of participation in this study and provided written informed consent. Healthy Control Group Healthy males matched to the wheelchair user group for age and sex. Individuals with no history of neurological or orthopedic disorders affecting lower limb motor function. Individuals who demonstrated a full understanding of participation in this study and provided written informed consent. Key exclusion criteria - Individuals with acute or uncontrolled cardiovascular diseases (e.g., heart failure, arrhythmia, angina pectoris). Individuals with severe respiratory diseases. Individuals with marked autonomic dysfunction presenting a high risk of exercise-induced hypotension or syncope. Individuals unable to safely perform arm crank exercise due to severe contracture, pain, or orthopedic disorders in the upper limbs. Individuals unable to understand the study, provide informed consent, or adhere to instructions due to cognitive impairment or psychiatric disorders. Individuals deemed unsuitable for participation by a physician for safety reasons. Target Size - 75

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 01 Month 21 Day Date of IRB - 2026 Year 01 Month 21 Day Anticipated trial start date - 2026 Year 01 Month 23 Day Last follow-up date - 2030 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069168

Disclaimer: Curated by HT Syndication.