Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062807) titled 'Subjective evaluation of the comfortability and functionality of the newly developed 2026 model ankle orthosis' on Sept. 3.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Shimane University
Condition:
Condition - None specified
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the comfort and functionality of a newly developed 2026 model ankle orthosis compared with a conventional orthosis based on users' subjective evaluations.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - 2026 model new-type ankle orthosis
Interventions/Control_2 - Conventional-type ankle orthosis
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Engages in sports activities at least twice a week.
2) Written consent for research participation has been obtained from the individual.
Key exclusion criteria - 1) The patient has a skin condition around the ankle joint or may develop skin damage due to wearing an orthotic device.
2) The patient is currently undergoing treatment for an injury or disease around the ankle joint.
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 19 Day
Date of IRB - 2026 Year 08 Month 24 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2027 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071903
Disclaimer: Curated by HT Syndication.
