Tokyo, Oct. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063236) titled 'Development of a lower limb asymmetry improvement device using vibration feedback for post-knee surgery patients' on Oct. 10.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Waseda University

Condition: Condition - Anterior Cruciate Ligament (ACL) injury and motor dysfunction after knee surgery Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To promote the conscious awareness of correct bilateral muscle activity in patients by enabling them to perceive the left-right asymmetry in muscle activation timing. This is achieved using a wearable device that converts the difference in force onset timing between the involved and uninvolved limbs into a physical sensation of "simultaneous bilateral vibration." Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Motion training (knee flexion/extension) using a device that calculates the difference in force onset timing between the involved and uninvolved limbs from lower leg acceleration, and presents vibration feedback to the involved limb with a temporal shift relative to the uninvolved limb.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Individuals aged 18 to 65 years. [Healthy subjects] Individuals with no history of lower limb trauma or surgery, no current orthopedic or neurological complaints, and confirmed via interview to have no difficulty performing the test movements. [Patients] Post-knee surgery patients, including those with ACL reconstruction, who are currently undergoing rehabilitation at the collaborating hospital. Key exclusion criteria - Individuals with uncontrolled heart failure, acute myocardial infarction, active myocarditis/pericarditis, unstable angina, acute systemic embolism/pulmonary embolism, or acute infection. Subjects will also be excluded if they exhibit abnormal symptoms during the test, such as moderate dyspnea, heart rate exceeding 140 bpm, or tachyarrhythmia. Target Size - 36

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 14 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072382

Disclaimer: Curated by HT Syndication.