Tokyo, March 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060918) titled 'Stratified Effectiveness of Knee Orthosis for Knee Osteoarthritis' on March 13.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Fukuoka Tenjin Medical Rehabilitation Academy
Condition:
Condition - Knee Osteoarthritis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Estimates indicate that 253 million patients in Japan are diagnosed with knee osteoarthritis based on plain radiographs Among musculoskeletal disorders osteoarthritis including knee osteoarthritis is the leading cause of disability requiring long term care certification Knee orthotic therapy for patients with knee osteoarthritis is established as a common treatment method but research demonstrating scientific evidence is insufficient and its general applicability is low This study aims to contribute to measures concerning orthotic therapy for knee osteoarthritis by measuring and understanding the effects of knee orthoses worn by patients with knee osteoarthritis
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Knee orthosis
Interventions/Control_2 - Without knee orthosis
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - Patients with knee osteoarthritis hospitalized or receiving outpatient care at research facilities, based on an estimated number derived from prior studies
Key exclusion criteria - Patients exhibiting functional impairment or pain that impedes measurement
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 01 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069145
Disclaimer: Curated by HT Syndication.