Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390033
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-29
First Post:
2024-03-13
Brief Title:
Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1000 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 111 011ms 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
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 1000 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 111 011ms 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 20 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None