A Study on the Biomechanical Mechanisms of Orthotic/Physical Training Correction of Hallux Valgus and Its Impact on the Lower Limbs

Обзор

The study population of this project is mainly young people. Our goal is to investigate the kinematic and kinetic characterization brought about by different conservative treatment modalities for hallux valgus. The main study involves recruiting volunteers, grouping them into 12-week interventions with orthotics or foot exercises, and analyzing the kinematic and kinetic alterations in young and middle-aged subjects before, during, and after cessation of the interventions by motion capture, surface electromyography, and musculoskeletal ultrasound. A database of human biomechanical characteristics was constructed through in-vivo exercise techniques to analyze changes in the biomechanical characteristics of the population with hallux valgus after the use of different intervention methods.

Вмешательства

• Устройство orthosis
  (1) one pair of two orthoses, regardless of the right and left sides; (2) loosen the two Velcro straps, put the large Velcro strap into the arch of the foot, and put the small Velcro strap on the thumb; (3) place the rigid plastic fixation plate along the medial edge of the foot and align the axis of rotation with the 1st metatarsalphalangeal joint; (4) tighten the Velcro straps as much as possible to prevent dislocation of the orthoses, without interfering with sleep; (5) tighten the Velcro str
• Поведенческое foot exercises
  1. Warm-up: 30 seconds per movement 1. Joint loosening 2. Plantar relaxation 2. Toe spreading: 10 reps/set, 3 sets/day 3. Toe grasping towel: 10 times/set, 3 sets/day 4. Standing Heel Raise: 10 times/group, 3 groups/day 5. Short Foot Exercise: 10 times/sets, 3 sets/day 6. Relax the soles of the feet again at the end of all exercises.

Первичные конечные точки

• Measuring muscle synergy using a 16-channel surface electromyography device [Срок оценки: From baseline to 12 weeks of intervention]
• Measuring kinematic synergy using optical infrared cameras [Срок оценки: From baseline to 12 weeks of intervention]

Вторичные конечные точки (3)

• Measuring hallux valgus angle with a protractor [Срок оценки: From baseline to 12 weeks of intervention]
• Using ultrasound diagnostic system to capture a cross-sectional image of the thickest part of the muscle for measuring the cross-sectional area of the muscle [Срок оценки: From baseline to 12 weeks of intervention]
• Using a force plate to measure the center of foot pressure [Срок оценки: From baseline to 12 weeks of intervention]

Критерии участия

Критерии включения

• Hallux valgus angle > 15°
• Age 18-45 years
• Right leg dominant (based on the Waterloo Foot Questionnaire)
• Bilateral hallux valgus

Критерии исключения

• History of lower limb surgery or neuromuscular diseases causing gait abnormalities (such as lumbar disc herniation and chronic ankle instability)
• Any treatment for hallux valgus within the past 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Китай · 1 центр

• Southern Medical University — Гуанчжоу

Публикации

• Liu Y, Liu R, Wan X, Chen C, Wang Y, Yu W, OuYang J, Qian L, Liu G. The Effect of Short-Term Kinesiology Taping on Neuromuscular Controls in Hallux Valgus During Gait: A Study of Muscle and Kinematic Synergy. IEEE Trans Neural Syst Rehabil Eng. 2024;32:3199-3209. doi: 10.1109/TNSRE.2024.3451651. Epub 2024 Sep 5. PMID 39208038

Идентификаторы

NCT: NCT07036120 · NFYKX003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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