- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07049198
- Original Trial
Real-time Motion Capture and Visual Feedback for Amputation Gait Training
July 1, 2025 updated by: Hui-Ting Shih, National Yang Ming Chiao Tung University
The Effect of a Real-time 2D Motion Capture and Visual Feedback Gait Training Systems on Walking Performance in People With Unilateral Transfemoral Amputation
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.
Study Overview
Status
Not yet recruiting
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui-Ting Shih
- Phone Number: +886 921 078 256
- Email: huiting.shih@nycu.edu.tw
Study Locations
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Taipei, Taiwan, 112
- National Yang Ming Chiao Tung University
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Contact:
- Hui-Ting Shih, PT, PhD
- Phone Number: +886-921078256
- Email: huiting.shih@nycu.edu.tw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
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Active Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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The step width ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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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)
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The step length ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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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).
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The stride time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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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).
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The stance time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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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).
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The swing time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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The hip extension angle is measured in the sagittal plane during terminal stance.
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The hip extension angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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The hip flexion angle is measured in the sagittal plane at the maximum angle of hip flexion during the swing phase.
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The hip flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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The trunk extension and flexion angle is measured in the sagittal plane at the initial contact and terminal stance.
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The trunk extension and flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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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.
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The hip adduction and abduction angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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The horizontal pelvis tilt angle is measured in the coronal plane at the maximum pelvis tilt angle during single-leg stance.
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The horizontal pelvis tilt angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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Trunk lateral flexion angle
Time Frame: The trunk lateral flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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The trunk lateral flexion angle is measured in the coronal plane during midstance.
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The trunk lateral flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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The Component Timed-Up-and-Go test will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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Gait speed
Time Frame: The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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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.
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The Activities-specific Balance Confidence Scale will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
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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.
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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.
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The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 15, 2025
Primary Completion (Estimated)
July 10, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
May 13, 2025
First Submitted That Met QC Criteria
July 1, 2025
First Posted (Actual)
July 3, 2025
Study Record Updates
Last Update Posted (Actual)
July 3, 2025
Last Update Submitted That Met QC Criteria
July 1, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- NYCU114067AE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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