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

NCT07049198 | Not Yet Recruiting

• 1 other identifier: NYCU114067AE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Transfemoral Amputation; Unilateral Knee Disarticulation

Outcome Measures

Primary Outcomes (11)

• Step width ratio

  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.

  The step width ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

• Step length ratio

  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)

  The step length ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

• Stride time ratio

  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).

  The stride time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

• Stance time ratio

  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).

  The stance time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

• Swing time ratio

  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).

  The swing time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

• Hip extension angle

  The hip extension angle is measured in the sagittal plane during terminal stance.

  The hip extension angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

• Hip flexion angle

  The hip flexion angle is measured in the sagittal plane at the maximum angle of hip flexion during the swing phase.

  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

  The trunk extension and flexion angle is measured in the sagittal plane at the initial contact and terminal stance.

  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

  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.

  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

  The horizontal pelvis tilt angle is measured in the coronal plane at the maximum pelvis tilt angle during single-leg stance.

  The horizontal pelvis tilt angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

• Trunk lateral flexion angle

  The trunk lateral flexion angle is measured in the coronal plane during midstance.

  The trunk lateral flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Secondary Outcomes (4)

• 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.

• 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.

Study Arms (2)

Real-time 2D motion capture and visual feedback system gait training group (VF)

EXPERIMENTAL

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.

Device: Real-time 2D motion capture and visual feedback system gait training

Conventional physical therapy group (PT)

ACTIVE COMPARATOR

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.

Other: Conventional physical therapy group

Interventions

Real-time 2D motion capture and visual feedback system gait training DEVICE

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.

Real-time 2D motion capture and visual feedback system gait training group (VF)

Conventional physical therapy group OTHER

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.

Conventional physical therapy group (PT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

Related Links

• Related Info

Central Study Contacts

Hui-Ting Shih

CONTACT

+886 921 078 256; huiting.shih@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: July 3, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

TW (1)