Overview

This trial is active, not recruiting.

Condition amputation
Treatments unrectified prosthetic socket, rectified prosthetic socket
Phase phase 2
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date April 2001
End date March 2005
Trial size 59 participants
Trial identifier NCT00061217, R01HD38919-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
socket selection
time frame:
PEQ
time frame:
gait speed
time frame:

Secondary Outcomes

Measure
gait kinematics
time frame:
gait kinetics
time frame:
energy consumption
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Comparison of Rectified and Unrectified Amputee Sockets
Principal investigator Jack R. Engsberg, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).