Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities - Trial NCT06390033

Timeline & Enrollment

Primary Outcome

Basic mobility function with two prostheses by Berg Balance Test,Basic mobility function with two prostheses by Time to Go Up,Basic mobility function with two prostheses by Four Square Step Test,Basic mobility function with two prostheses by 10-meter Walk Test,Stability index with two prostheses by Eye Close Standing,Stability index with two prostheses by Tandem Test,Functional Reach Test,Gait symmetry analysis of lower limb joint angle,Gait symmetry analysis of lower limb joint power,Gait symmetry analysis of lower limb joint moment,Walking feasibility with two prostheses,Jump feasibility with two prostheses,Subjective evaluation by Locomotion Capabilities Index questionnaire

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.

ICD-10 Classifications