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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • National Yang Ming Chiao Tung University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: 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)
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.
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
Time Frame: 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).
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.
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
Time Frame: 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.
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.
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
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.
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
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.
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
Time Frame: 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.
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
Time Frame: 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.
The trunk lateral flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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 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 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.
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 National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming Chiao Tung University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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