Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities
- Conditions
- AmputationProsthesis User
- Interventions
- Device: Prosthetic foot
- Registration Number
- NCT06390033
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
The goal of this observational study is to evaluate and compare the performance of two prosthetic feet for unilateral transtibial amputees during both indoor and outdoor activities. The main research questions aim to answer are:
1. Can a low-cost prosthetic foot enhance gait mechanics and physical performance in individuals who have undergone traumatic unilateral transtibial amputation, as compared to the traditional K2 - K3 prosthetic feet currently available on the market, during both indoor and outdoor activities?
2. Can the low-cost prosthetic foot meet user satisfaction levels after traumatic unilateral transtibial amputation, when compared to the traditional K2 - K3 prosthetic foot on the market?
Participants will be asked to do
1. Prior to the commencement of the experiment, a professional prosthetist and orthotist will conduct all fitting and alignment procedures for the transtibial amputees. Participants will then be given a two to three-week period to train and acclimate to the individual socket alignment and prosthetic foot.
2. Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests.
3. Participants will be required to perform the Berg Balance Test.
4. Participants will undergo a series of clinical tests, including: 1) Time to Go Up (measured in seconds), 2) Four Square Step Test (measured in seconds), 3) 10-Meter Walk Test (measured in seconds), 4) Eye Close Standing, 5) Tandem Test, and 6) Functional Reach Test. Each test will be conducted three times. The test items of 4) and 5) will be performed on a force plate (Bertect, Ohio, USA) with dimensions of 400 x 600 mm and a capturing frequency of 1,000 Hz.
5. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis.
6. Participants will perform the Counter Movement Jump Test three times with maximum effort on the force plate (Bertect, Ohio, USA), which will be performed without a hand swing.
7. Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively.
8. Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire.
- Detailed Description
Thirty-nine passive-reflective markers of 14 mm in diameter were placed on the participant (Figure 1) according to the landmarks set of the plug-in full body model. An 8-camera motion capturing system (VICON, Nexus 2.0 Inc., Oxford, UK) and 2 force plates (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) mounted under the walkway were utilized for gait analysis and recorded 100 frames per second simultaneously. All the systems were calibrated before the experiment.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 6
- unilateral transtibial amputees,
- with more than 12 months of experience using a prosthesis,
- with a K2 prosthesis or above,
- be able to walk continuously unaided with the prosthetic foot for at least 20 minutes.
- with a short or an injured residual limb,
- pregnant,
- any neurological or musculoskeletal diseases,
- have a record of active endocarditis and acute myocarditis/pericarditis,
- experience ongoing unstable angina,
- have uncontrolled cardiac arrhythmia with hemodynamic compromise,
- have had a recent stroke or transient ischemic attack,
- have high blood pressure, etc.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A low-cost prosthesis Prosthetic foot Unilateral transtibial amputees will engage in both indoor and outdoor activities, utilizing a low-cost prosthesis K2 or above prosthesis Prosthetic foot Unilateral transtibial amputees will engage in both indoor and outdoor activities, utilizing a K2 or above prosthesis.
- Primary Outcome Measures
Name Time Method Basic mobility function with two prostheses by Time to Go Up up to 12 weeks Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting Time to Go Up (seconds), including stand up from chair, walk 3 meters, turn around and back, then sit.
Basic mobility function with two prostheses by Four Square Step Test up to 12 weeks Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting Four Square Step Test (seconds).
Stability index with two prostheses by Tandem Test up to 12 weeks Participants will be invited to the laboratory twice to participate in an experiment. In each session, they will be required to perform the Tandem Test on a force plate (Bertect, Ohio, USA). The test will be conducted three times, with each attempt lasting 30 seconds. Participants will perform the task using either a low-cost prosthesis or their own prosthetic foot. The averaged anterior-posterior stability index (mm), and medial-lateral stability index (mm) will be calculated automatically by Noraxon software for each task to assess the ability of maintaining posture stability with two prostheses.
Gait symmetry analysis of lower limb joint power up to 12 weeks For collecting the kinematic and kinetic data for gait symmetry analysis, thirty-nine passive-reflective markers were placed on the participant according to the landmarks set of the plug-in full body model. An 8-camera motion capturing system (VICON, Nexus 2.0 Inc., Oxford, UK) and 2 force plates (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) mounted under the walkway were recorded 100 frames per second simultaneously. All the systems were calibrated before the experiment. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis. The power (W/kg) of symmetry index with two prostheses during gait will be compared.
Walking feasibility with two prostheses up to 12 weeks Participants will be invited to visit the campus twice to participate in an experiment. During each visit, they will be asked to walk on flat ground, stairs, and a ramp for two minutes each, using either a low-cost prosthesis or their own prosthetic foot. The distances (meters) covered with the two different prostheses will then be compared.
Functional Reach Test up to 12 weeks Participants will move from the vertical standing position to the maximum lean forward position, with the feet firmly placed on the floor with either prosthetic foot for three times. The averaged distance (cm) with two prostheses will be compared.
Basic mobility function with two prostheses by Berg Balance Test up to 12 weeks Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting Berg Balance Test including 14 items, each item is graded using a 5-point ordinal scale.
Basic mobility function with two prostheses by 10-meter Walk Test up to 12 weeks Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting 10-Meter Walk Test (m/s).
Stability index with two prostheses by Eye Close Standing up to 12 weeks Participants will be invited to the laboratory twice to participate in an experiment. In each session, they will be required to perform the Eye Close Standing on a force plate (Bertect, Ohio, USA). The test will be conducted three times, with each attempt lasting 30 seconds. Participants will perform the task using either a low-cost prosthesis or their own prosthetic foot. The averaged anterior-posterior stability index (mm), and medial-lateral stability index (mm) will be calculated automatically by Noraxon software for each task to assess the ability of maintaining posture stability with two prostheses.
Gait symmetry analysis of lower limb joint angle up to 12 weeks For collecting the kinematic and kinetic data for gait symmetry analysis, thirty-nine passive-reflective markers were placed on the participant according to the landmarks set of the plug-in full body model. An 8-camera motion capturing system (VICON, Nexus 2.0 Inc., Oxford, UK) and 2 force plates (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) mounted under the walkway were recorded 100 frames per second simultaneously. All the systems were calibrated before the experiment. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis. The joint angle (degree) of symmetry index with two prostheses during gait will be compared.
Gait symmetry analysis of lower limb joint moment up to 12 weeks For collecting the kinematic and kinetic data for gait symmetry analysis, thirty-nine passive-reflective markers were placed on the participant according to the landmarks set of the plug-in full body model. An 8-camera motion capturing system (VICON, Nexus 2.0 Inc., Oxford, UK) and 2 force plates (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) mounted under the walkway were recorded 100 frames per second simultaneously. All the systems were calibrated before the experiment. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis. The moment (Nm/kg) of symmetry index with two prostheses during gait will be compared.
Jump feasibility with two prostheses up to 12 weeks Participants will be invited to visit the laboratory twice to participate in an experiment. During each visit, they will be asked to perform the countermovement jump on the force plate (Bertect, Ohio, USA) for three times, using either a low-cost prosthesis or their own prosthetic foot. The average of three times jump height, vertical ground reaction force during different jump phases with two different prostheses will be compared.
Subjective evaluation by Locomotion Capabilities Index questionnaire up to 12 weeks participants will be asked to complete the Locomotion Capabilities Index questionnaire including 14 items, each rated with a 5-level scale.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Hong Kong Polytechnic University
🇭🇰Kowloon, Hong Kong