Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060767) titled 'Biomechanical evaluation of hemiparetic gait during high-speed treadmill walking with ankle assist' on Feb. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Gakkentoshi Hospital

Condition: Condition - Ambulatory stroke patients with hemiparesis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to investigate biomechanical changes in hemiparetic gait during high-speed treadmill walking with ankle assist in individuals with post-stroke hemiparesis. Specifically, the study observationally evaluates changes in propulsive force and walking speed associated with push-off assistance. The study aims to assess gait characteristics and does not evaluate therapeutic efficacy. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants will perform a high-speed treadmill walking task with an ankle assist mechanism driven by artificial muscles that provide active push-off assistance.

The initial treadmill speed will be set at 0.2 m/s below the participant's maximum walking speed and will be increased within an individually tolerable range. Each session will consist of 3 trials of 10 s, and a total of 10 sessions will be conducted.

This task is conducted to evaluate changes in gait kinematics and kinetics associated with ankle assist. Interventions/Control_2 - Participants will perform high-speed treadmill walking without ankle assist. The treadmill speed and task volume will be identical to those of the assist condition. This condition is included solely for biomechanical comparison and does not represent a therapeutic control.

Eligibility: Age-lower limit - 47 years-old = Gender - Male and Female Key inclusion criteria - 1.Hemiparetic stroke patients within 6 months post-onset. 2.Ability to walk independently using an ankle-foot orthosis and a cane. 3.Provision of written informed consent for study participation Key exclusion criteria - 1.Presence of bone or joint diseases affecting gait. 2.Gait disturbance caused by neuromuscular diseases other than the primary stroke. 3.Inability to follow test instructions due to aphasia or dementia. Target Size - 16

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2022 Year 09 Month 01 Day Date of IRB - 2021 Year 05 Month 01 Day Anticipated trial start date - 2026 Year 02 Month 28 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069372

Disclaimer: Curated by HT Syndication.