The Effect of a Real-time 2D Motion Capture and Visual Feedback Gait Training Systems on Walking Performance in People With Unilateral Transfemoral Amputation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Step width ratio
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Uncorrected visual impairments
- •Congenital limb deficiency
研究组 & 干预措施
Real-time 2D motion capture and visual feedback system gait training group (VF)
The VF group, the 2D motion capture and visual feedback training group, received an intervention consisting of 10 minutes of strength training followed by 30 minutes of visual feedback gait training using the 2DMV system.
干预措施: Real-time 2D motion capture and visual feedback system gait training (Device)
Conventional physical therapy group (PT)
The PT group, the conventional physical therapy group, received an intervention consisting of 10 minutes of strength training followed by 30 minutes of gait training without the use of the 2DMV system for visual feedback. During gait training, the therapist provided standard gait correction feedback typically used in conventional physical therapy.
干预措施: Conventional physical therapy group (Other)
结局指标
主要结局
Step width ratio
时间窗: The step width ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Step width ratio is calculated by dividing step width by pelvis width (step width/pelvis width), and the normal range is between 0.4 to 1.1.
Stride time ratio
时间窗: The stride time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Stride time ratio is calculated by dividing the stride time of the amputated limb by the stride time of the non-amputated limb (a value closer to 1 indicates more symmetry, the stride time of the amputated limb is calculated as the time from initial contact of the amputated limb to next initial contact of the same limb; the stride time of the non-amputated limb is calculated as the time from initial contact of the non-amputated limb to next initial contact of the same limb).
Stance time ratio
时间窗: The stance time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Stance time ratio is calculated by dividing the stance time of the amputated limb by the stance time of the non-amputated limb (a value closer to 1 indicates more symmetry, the stance time is calculated from initial contact to toe off of the same limb).
Swing time ratio
时间窗: The swing time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Swing time ratio is calculated by dividing the swing time of the amputated limb by the swing time of the non-amputated limb (a value closer to 1 indicates more symmetry, the swing time is calculated from toe off to initial contact of the same limb).
Hip adduction and abduction angle
时间窗: The hip adduction and abduction angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The hip adduction and abduction angle is measured in the coronal plane at the maximum angle of hip adduction or abduction angle during the swing phase.
Step length ratio
时间窗: The step length ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Step length ratio is calculated by dividing the step length of the amputated limb by the step length of the non-amputated limb (a value closer to 1 indicate more symmetry, the step length of amputated limb is calculated as the distance between the heel of the non-amputated limb when initial contact and the heel of the amputated limb when initial contact; the step length of non-amputated limb is calculated as the distance between the heel of the amputated limb when initial contact and the heel of the non-amputated limb when initial contact)
Hip extension angle
时间窗: The hip extension angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The hip extension angle is measured in the sagittal plane during terminal stance.
Hip flexion angle
时间窗: The hip flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The hip flexion angle is measured in the sagittal plane at the maximum angle of hip flexion during the swing phase.
Trunk extension and flexion angle
时间窗: The trunk extension and flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The trunk extension and flexion angle is measured in the sagittal plane at the initial contact and terminal stance.
Horizontal pelvis tilt angle
时间窗: The horizontal pelvis tilt angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The horizontal pelvis tilt angle is measured in the coronal plane at the maximum pelvis tilt angle during single-leg stance.
Trunk lateral flexion angle
时间窗: The trunk lateral flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The trunk lateral flexion angle is measured in the coronal plane during midstance.
次要结局
- The Activities-specific Balance Confidence Scale, ABC scale(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(The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.)
- The Component Timed-Up-and-Go test, cTUG(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(The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.)
研究者
Hui-Ting Shih
Assistant Professor
National Yang Ming Chiao Tung University