Tokyo, Oct. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062927) titled 'Comparison of Lower Limb Joint Angles and Muscle Activity During Gait Based on Differences in Plantarflexion Resistance of Ankle-Foot Orthoses' on Oct. 9.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Niigata University of Health and Welfare
Condition:
Condition - Post-stroke hemiplegia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study compares lower-limb joint angles and muscle activity during walking in individuals with hemiplegia, using ankle-foot orthoses with varying degrees of plantarflexion resistance, to verify whether the devices possess a practical mechanism for adjusting plantarflexion resistance.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ankle-foot orthosis with plantarflexion control
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Stroke patients presenting with hemiplegia
Key exclusion criteria - Individuals who have difficulty walking even with proximal supervision by a physical therapist; individuals who have difficulty understanding verbal instructions due to impaired consciousness or aphasia; and individuals exhibiting marked limitation of knee extension or ankle dorsiflexion.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 10 Month 01 Day
Anticipated trial start date - 2026 Year 10 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/icdr_e/ctr_view.cgi?recptno=R000072051
Disclaimer: Curated by HT Syndication.
