Tokyo, Dec. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059999) titled 'Development and Clinical Evaluation of a Gluteus Medius Assistive Device for Abnormal Gait Correction' on Dec. 5.

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 - -Knee osteoarthritis -Trendelenburg gait Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Verification of the Gait-Correction Effect of an Assistive Motion Device Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will walk for 10 minutes at a unified walking cadence of 100 bpm while wearing the device. The examiner will give the start and stop instructions, and lateral knee acceleration, pelvic frontal plane inclination angle, and other gait data will be continuously recorded during walking. The assistive mechanism of the device will operate in the normal support mode, and the intervention will be conducted while ensuring safety at all times.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - - Individuals who request to participate in training using the motion-assist orthosis, have been diagnosed with an abnormal gait, require the use of a corrective orthosis, and are deemed eligible for participation by both the attending physician and the physical therapist. - Healthy older adults who request to participate in training using the motion-assist orthosis. Key exclusion criteria - 1. Uncontrolled heart failure 2. Acute myocardial infarction 3. Active myocarditis or pericarditis 4. Unstable angina 5. Acute systemic embolism or pulmonary embolism 6. Acute infectious disease 7. Thrombophlebitis 8. Ventricular tachycardia or refractory ventricular arrhythmia 9. Severe left ventricular outflow tract obstruction 10. Uncontrolled arterial hypertension or pulmonary hypertension 11. Participation in another interventional study during the same period (to be verbally confirmed with the responsible physical therapist) * The exclusion criteria will be determined by the attending physician. Target Size - 48

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 05 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068616

Disclaimer: Curated by HT Syndication.