Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061217
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-05-22
Brief Title:
Prosthetic Limbs After Leg Amputation Alternative Method of Socket Design
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Comparison of Rectified and Unrectified Amputee Sockets
Status:
UNKNOWN
Status Verified Date:
2004-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
People who have had a leg amputated often choose to use a prosthetic artificial leg This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee
Detailed Description:
The traditional assumption when fabricating a transtibial amputee TTA socket is that the residual limb is not homogeneous in its ability to tolerate load As a result prosthetic sockets are currently fabricated by modifying a positive mold to account for this non-homogeneity these are called rectified sockets Unrectified sockets retain the shape of the residual limb except for a distal end pad Unrectified sockets use an alginate gel method of fabricating that is simpler and less time consuming than the method used to fabricate rectified sockets This study will compare patient satisfaction and function with rectified and unrectified sockets
Participants in this study will be randomized to either a recitified socket group or an unrectified socket group Participants will wear the socket for a minimum of 4 weeks Participants will then fill out a Prosthesis Evaluation Questionnaire PEQ The PEQ quantifies patient satisfaction by evaluating nine validated scales Functional measures of energy expenditure kinematics and ground reaction forces during gait will also be collected After 4 weeks participants in the rectified socket group will switch to an unrectified socket and participants in the unrectified socket group will switch to a rectified socket At the end of 4 weeks with the new socket participants will once again fill out the PEQ and undergo functional assessment At the end of study participation each participant will freely choose the socket they wish to have in their final prosthesis
Thus far 10 study participants with unilateral transtibial amputations have been evaluated after randomly wearing both rectified and unrectified sockets for 4 weeks Results indicated no differences between sockets for gait speed and timing gait kinematics and kinetics gait energy expenditure and Rate of Perceived Exertion RPE There were also no differences in the Prosthetic Evaluation Questionnaire Four participants selected the rectified socket and 6 selected the unrectified socket as their exit socket
Participants in this study will be randomized to either a recitified socket group or an unrectified socket group Participants will wear the socket for a minimum of 4 weeks Participants will then fill out a Prosthesis Evaluation Questionnaire PEQ The PEQ quantifies patient satisfaction by evaluating nine validated scales Functional measures of energy expenditure kinematics and ground reaction forces during gait will also be collected After 4 weeks participants in the rectified socket group will switch to an unrectified socket and participants in the unrectified socket group will switch to a rectified socket At the end of 4 weeks with the new socket participants will once again fill out the PEQ and undergo functional assessment At the end of study participation each participant will freely choose the socket they wish to have in their final prosthesis
Thus far 10 study participants with unilateral transtibial amputations have been evaluated after randomly wearing both rectified and unrectified sockets for 4 weeks Results indicated no differences between sockets for gait speed and timing gait kinematics and kinetics gait energy expenditure and Rate of Perceived Exertion RPE There were also no differences in the Prosthetic Evaluation Questionnaire Four participants selected the rectified socket and 6 selected the unrectified socket as their exit socket
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None