Prosthetic Limbs After Leg Amputation: Alternative Method of Socket Design

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2004 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Recruitment status was Active, not recruiting

First Received on May 22, 2003. Last Updated on June 23, 2005 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00061217

Purpose

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.

Condition	Intervention	Phase
Amputation	Device: Unrectified prosthetic socket Device: Rectified prosthetic socket	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Comparison of Rectified and Unrectified Amputee Sockets

Resource links provided by NLM:

MedlinePlus related topics: Limb Loss

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

socket selection
PEQ
gait speed

Secondary Outcome Measures:

gait kinematics
gait kinetics
energy consumption

Estimated Enrollment:	59
Study Start Date:	April 2001
Estimated Study Completion Date:	March 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Unilateral transtibial amputation
Mature residual limbs (i.e., no major change in stump volume due to atrophy or other destabilizing factors)
Continuously worn a prosthesis for at least 1 year prior to study entry
Scheduled for a new prosthesis
Independent ambulation
No acute health problems

Exclusion Criteria

Constant recurring prosthetic problems (i.e., adherent scar tissue, neuromas, bony protuberances at distal end)
Requires gel inserts, additional ply socks, or other atypical fitting components or methods
Health status that prohibits patient from performing graded exercise test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061217

Locations

United States, Missouri
Jack R. Engsberg
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Jack R. Engsberg, Ph.D.

More Information

Publications:

Engsberg JR, Sprouse SW, Uhrich ML, Ziegler B Preliminary Investigation Comparing Rectified and Unrectified Sockets for Transtibial Amputees. Journal of Prosthetics and Orthotics 15(4):119-124, 2003

ClinicalTrials.gov Identifier:	NCT00061217 History of Changes
Other Study ID Numbers:	R01HD38919-02
Study First Received:	May 22, 2003
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Transtibial amputees
Rectified sockets
Unrectified sockets

Gait
Energy expenditure
Prosthetic evaluation questionnaire

ClinicalTrials.gov processed this record on February 12, 2012