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Clinical Trials/NCT00061217
NCT00061217
Unknown
Phase 2

Comparison of Rectified and Unrectified Amputee Sockets

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)1 site in 1 country59 target enrollmentApril 2001
ConditionsAmputation

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Amputation
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Enrollment
59
Locations
1
Primary Endpoint
socket selection
Last Updated
20 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2001
End Date
March 2005
Last Updated
20 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

socket selection

PEQ

gait speed

Secondary Outcomes

  • gait kinematics
  • gait kinetics
  • energy consumption

Study Sites (1)

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