Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433648
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-16
Brief Title:
Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
Status:
RECRUITING
Status Verified Date:
2024-05
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 study is to understand how providing power at the knee or ankle individually or providing power at both the knee and ankle impacts ambulation for K2 level transfemoral amputees
Aim 1 measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis Ottobock ClegOttobock foot or a powered knee and ankle prosthesis SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle
Aim 2 Participants will be evaluated on the contribution of adding power at the knee only or the ankle only
Aim 3 The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis SRALab Hybrid Knee and SRALab Polycentric Powered Ankle
Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements
Aim 1 measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis Ottobock ClegOttobock foot or a powered knee and ankle prosthesis SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle
Aim 2 Participants will be evaluated on the contribution of adding power at the knee only or the ankle only
Aim 3 The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis SRALab Hybrid Knee and SRALab Polycentric Powered Ankle
Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements
Detailed Description:
Amputation of the lower limb causes profound disability significantly limiting mobility independence and the ability to pursue employment or leisure activities Nearly 90 of all lower limb amputations in the United States occur in older persons mostly due to vascular disease and this population is expected to triple by 2050 After lower limb loss individuals walk more slowly and more asymmetrically are less stable and expend more metabolic energy during walking than persons with intact limbs Even when using state-of-the-art microprocessor-controlled prostheses typically a microprocessor knee with a passive ankle persons with transfemoral amputations expend approximately 60 more energy than able-bodied individuals during ambulation In addition to the physical limitations caused by the amputation the increased energy requirements affect performance of everyday activities including getting up out of a chair or off the toilet or stepping up or down a curb
Most commercially available prosthetic legs are passive The movement of a passive prosthetic joint relies on the properties of its mechanical components such as hydraulic or pneumatic valves or sliding joints together with compensatory adjustments made by the user Since these computerized prostheses are passive the user cannot efficiently negotiate stairs an incline or the numerous other functions that require net knee andor ankle power
Powered prostheses can actively generate joint torque allowing easy and efficient performance of more demanding activities such as ascending stairs and hills Powered knees and ankles may allow for better outcomes in both older and younger individuals with transfemoral amputation this powered componentry may enable more energy efficient walking allow users to stand up from a seated position with ease and enable them to walk across more challenging terrains-such as up and down hills ramps and stairs-safely and with more normal and symmetric gait kinematics and kinetics
This study will demonstrate the functional benefits of adding power at an individual joint This knowledge will be critical for prioritizing future device development and will provide valuable information for clinicians and individuals on selecting appropriate componentry for transfemoral K2 amputees
Most commercially available prosthetic legs are passive The movement of a passive prosthetic joint relies on the properties of its mechanical components such as hydraulic or pneumatic valves or sliding joints together with compensatory adjustments made by the user Since these computerized prostheses are passive the user cannot efficiently negotiate stairs an incline or the numerous other functions that require net knee andor ankle power
Powered prostheses can actively generate joint torque allowing easy and efficient performance of more demanding activities such as ascending stairs and hills Powered knees and ankles may allow for better outcomes in both older and younger individuals with transfemoral amputation this powered componentry may enable more energy efficient walking allow users to stand up from a seated position with ease and enable them to walk across more challenging terrains-such as up and down hills ramps and stairs-safely and with more normal and symmetric gait kinematics and kinetics
This study will demonstrate the functional benefits of adding power at an individual joint This knowledge will be critical for prioritizing future device development and will provide valuable information for clinicians and individuals on selecting appropriate componentry for transfemoral K2 amputees
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?:
False
Is an FDA AA801 Violation?:
None