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

Official title

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

Overview

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.

Interventions

• Device 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.
• Other 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.

Primary outcome measures

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

Secondary outcome measures (4)

• The Component Timed-Up-and-Go test, cTUG [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• National Yang Ming Chiao Tung University — Taipei

Identifiers

NCT: NCT07049198 · NYCU114067AE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗