Tokyo, May 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061708) titled 'Pilot study investigating the effects of forefoot design of ankle-foot orthoses on gait' on May 28.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Seijoh University
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This exploratory pilot study aims to investigate the effects of different forefoot designs of ankle-foot orthoses (AFOs) on gait mechanics in healthy adults. As a preliminary investigation for future studies involving children with cerebral palsy, gait characteristics during walking with a forefoot-cut AFO and a rigid forefoot AFO will be compared.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Gait assessment will be performed under the barefoot condition.
Interventions/Control_2 - Gait assessment will be performed while wearing a forefoot-cut ankle-foot orthosis (AFO).
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - Individuals who provided informed consent for study participation
Healthy male adults aged 18 to 30 years
Individuals compatible with the orthosis size (foot length: 26.5 cm)
Key exclusion criteria - Individuals with gait impairment
Individuals for whom surface electromyography electrode placement is difficult due to skin disorders or related conditions
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 01 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2026 Year 12 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070616
Disclaimer: Curated by HT Syndication.
