Real-time Motion Capture and Visual Feedback for Amputation Gait Training

Официальное название

The Effect of a Real-time 2D Motion Capture and Visual Feedback Gait Training Systems on Walking Performance in People With Unilateral Transfemoral Amputation

Обзор

People with transfemoral amputation face challenges such as gait asymmetry, instability, and increased energy consumption due to loss of the knee joint. Because of the loss of proprioceptive feedback from their missing limbs, visual feedback is essential for gait correction. Additionally, current visual feedback systems lack portability, cost-effectiveness, and they fail to provide precise, intuitive feedback on spatiotemporal parameters, joint angles, and both frontal and sagittal plane information, limiting their effectiveness in correcting gait abnormalities.This study aims to investigate whether gait training using a real-time 2D motion capture and visual feedback gait training system (2DMV) can improve the gait biomechanics and psychosocial functions of people with unilateral transfemoral amputation (uTFA). The 2DMV system analyzes spatiotemporal parameters and joint kinematics during gait and displays the uTFA's image on a screen, providing visual feedback specifically targeting gait abnormalities. This allows individuals with uTFA to intuitively understand the feedback and make real-time gait adjustments. The biomechanical parameters include joint kinematics, gait symmetry, and walking performance.

Вмешательства

• Устройство Real-time 2D motion capture and visual feedback system gait training
  The difference between the VF group and the PT group lies in the use of real-time visual feedback during gait training; the VF group receives real-time visual feedback, while the PT group undergoes gait training without visual feedback.
• Другое Conventional physical therapy group
  Ten minutes of strength training followed by thirty minutes of gait training, during which the 2DMV system is not used to provide visual feedback. During the gait training, the therapist provides gait correction feedback typically used in conventional physical therapy.

Первичные конечные точки

• Step width ratio [Срок оценки: The step width ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Step length ratio [Срок оценки: The step length ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Stride time ratio [Срок оценки: The stride time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Stance time ratio [Срок оценки: The stance time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Swing time ratio [Срок оценки: The swing time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Hip extension angle [Срок оценки: The hip extension angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Hip flexion angle [Срок оценки: The hip flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Trunk extension and flexion angle [Срок оценки: The trunk extension and flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Hip adduction and abduction angle [Срок оценки: The hip adduction and abduction angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Horizontal pelvis tilt angle [Срок оценки: The horizontal pelvis tilt angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]

Вторичные конечные точки (4)

• The Component Timed-Up-and-Go test, cTUG [Срок оценки: The Component Timed-Up-and-Go test will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• Gait speed [Срок оценки: The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• The Activities-specific Balance Confidence Scale, ABC scale [Срок оценки: The Activities-specific Balance Confidence Scale will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.]
• The National Aeronautics and Space Administration Task Load Index, NASA-TLX [Срок оценки: The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.]

Критерии участия

Критерии включения

• Age between 18 and 65 years
• Individuals with unilateral transfemoral amputation or knee disarticulation
• Wear a prosthesis for at least 3 hours per day
• Have been using a prosthesis for more than 6 months
• Medicare Functional Classification Level (K-level) of 2 or above
• Able to walk independently for 5 meters without assistive devices
• No pain caused by poor prosthetic fit
• Montreal Cognitive Assessment Taiwan Version (MoCA-T) score ≥ 26

Критерии исключения

• Uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension)
• Cardiopulmonary or cardiovascular diseases (e.g., heart failure, severe asthma)
• History of neurological conditions that affect movement (e.g., stroke, spinal cord injury, cerebellar injury)
• Vestibular disorders
• Severe osteoporosis
• Other musculoskeletal injuries or open wounds
• Epilepsy
• Uncorrected visual impairments
• Congenital limb deficiency

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Yang Ming Chiao Tung University — Taipei

Идентификаторы

NCT: NCT07049198 · NYCU114067AE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗