Unilateral Transfemoral AmputationNCT07049198
Real-time Motion Capture and Visual Feedback for Amputation Gait Training
A study testing Real-time 2D motion capture and visual feedback system gait training and Conventional physical therapy group in people with Unilateral Transfemoral Amputation and Unilateral Knee Disarticulation, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unilateral Transfemoral Amputation, Unilateral Knee Disarticulation
- What is being tested?
- Real-time 2D motion capture and visual feedback system gait training and Conventional physical therapy group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Epilepsy
- Uncorrected visual impairments
- Congenital limb deficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Yang Ming Chiao Tung University
Taipei, 112
Hui-Ting Shih, PT, PhD, +886-921078256, huiting.shih@nycu.edu.tw
About this study
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
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.
- Being tested
- Real-time 2D motion capture and visual feedback system gait training, Conventional physical therapy group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time 2D motion capture and visual feedback system gait trainingDevice
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.
Conventional physical therapy groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional physical therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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
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.
Measured: 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 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.
Measured: 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 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.
Measured: The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion10 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Transfemoral AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Ting Shih, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049198
- Sponsor's protocol ID
- NYCU114067AE
- Status last verified
- Jul 2025
- First submitted
- 13 May 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07049198
- Acronym / sponsor ID
- NYCU114067AE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time 2D motion capture and visual feedback system gait training group (VF) | Experimental | Device: Real-time 2D motion capture and visual feedback system gait trainingThe 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. |
| Conventional physical therapy group (PT) | Active comparator | Other: Conventional physical therapy groupThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time 2D motion capture and visual feedback system gait trainingThe 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. | Device | Real-time 2D motion capture and visual feedback system gait training group (VF) |
| Conventional physical therapy groupTen 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. | Other | Conventional physical therapy group (PT) |
Primary outcome
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.
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)
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).
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).
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).
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.
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.
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.
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.
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.
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time 2D motion capture and visual feedback system gait training and Conventional physical therapy group in people with Unilateral Transfemoral Amputation and Unilateral Knee Disarticulation, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Ting Shih (+886 921 078 256, huiting.shih@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.