Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058599) titled 'A Study to Examine the Effects of Insoles Designed Based on Physical Therapist Assessment' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Kio University
Condition:
Condition - Individuals with musculoskeletal disorders affecting the lower limb and trunk
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of custom-made insoles designed based on physical therapist assessment on lower limb and trunk function and pain in users.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - insole
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Those who have had insoles made based on the evaluation of a physical therapist
Key exclusion criteria - Those who cannot walk independently
Those who are judged to have a neurological disorder or other condition that affects their walking more than the effect of insoles.
Target Size - 500
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 25 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067002
Disclaimer: Curated by HT Syndication.
