Real-time Motion Capture and Visual Feedback for Amputation Gait Training
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational Yang Ming Chiao Tung University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Real-time 2D motion capture and visual feedback system gait training
DeviceThe 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 group
Other interventionTen 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Real-time 2D motion capture and visual feedback system gait training group (VF)Experimental treatment 1 intervention
Group B: Conventional physical therapy group (PT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The step width ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.2
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)
Time frame
The step length ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.3
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).
Time frame
The stride time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.4
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).
Time frame
The stance time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.Secondary outcomes
1
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.
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.2
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.
Time frame
The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.3
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.
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.4
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.
Time frame
The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.Sponsors and contacts
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Source ClinicalTrials.gov
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