protocolSection identificationModule nctId: NCT06390033, orgStudyIdInfo id: ITS/133/21, briefTitle: Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-06-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: 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 do1. 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., conditionsModule conditions: Amputation, conditions: Prosthesis User, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Prosthetic foot, outcomesModule primaryOutcomes measure: Basic mobility function with two prostheses by Berg Balance Test, primaryOutcomes measure: Basic mobility function with two prostheses by Time to Go Up, primaryOutcomes measure: Basic mobility function with two prostheses by Four Square Step Test, primaryOutcomes measure: Basic mobility function with two prostheses by 10-meter Walk Test, primaryOutcomes measure: Stability index with two prostheses by Eye Close Standing, primaryOutcomes measure: Stability index with two prostheses by Tandem Test, primaryOutcomes measure: Functional Reach Test, primaryOutcomes measure: Gait symmetry analysis of lower limb joint angle, primaryOutcomes measure: Gait symmetry analysis of lower limb joint power, primaryOutcomes measure: Gait symmetry analysis of lower limb joint moment, primaryOutcomes measure: Walking feasibility with two prostheses, primaryOutcomes measure: Jump feasibility with two prostheses, primaryOutcomes measure: Subjective evaluation by Locomotion Capabilities Index questionnaire, eligibilityModule sex: ALL, minimumAge: 36 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, city: Kowloon, zip: 999077, country: Hong Kong, geoPoint lat: 22.31667, lon: 114.18333, hasResults: False