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

Not Applicable

Not yet recruiting

• Conditions: Unilateral Knee Disarticulation; Unilateral Transfemoral Amputation

• Registration Number: NCT07049198
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-13
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Study Start: 2025-07-15
• Primary Completion: 2027-07-10
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stance time ratio	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).
Trunk lateral flexion angle	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.
Step width ratio	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	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).
Swing time ratio	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	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	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
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 Activities-specific Balance Confidence Scale is a self-reported questionnaire used to assess balance confidence. Scores range from 0% to 100%, with higher scores indicating greater confidence. The scale consists of 16 items in total.
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 National Aeronautics and Space Administration Task Load Index is a self-repoted scale, totally has 6 items, including mental demand, physical demand, temporal demand, performance, effort, and frustration. The score will recorded as 0 to 100, with the higher score indicating higher work load.
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.	The participant will first be instructed to sit on a chair with a backrest. When the assessor says 'go,' the participant will stand up, walk forward, circle around a cone, return to the chair, and sit down, all at a self-selected speed. The assessor will time the duration of the entire process. The timing of the Component Timed-Up-and-Go test will be divided into five components: standing up, walking forward, circling around the cone, walking back to the chair, and sitting down. Time will be measured in seconds.
Gait speed	The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.	Gait speed will be measured by the assessor with a timer. The participant will be instructed to walk 5 meters at a self-selected speed. The first and last 1 meter will serve as the acceleration and deceleration phases, while the gait speed in middle 3 meters will be measured. Time will be measured in seconds.

Trial Locations

Locations (1)

National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan