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Prosthetic Limbs After Leg Amputation: Alternative Method of Socket Design

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ClinicalTrials.gov Identifier: NCT00061217
Recruitment Status : Unknown
Verified October 2004 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
First Posted : May 23, 2003
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Condition or disease Intervention/treatment Phase
Amputation Device: Unrectified prosthetic socket Device: Rectified prosthetic socket Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Rectified and Unrectified Amputee Sockets
Study Start Date : April 2001
Study Completion Date : March 2005



Primary Outcome Measures :
  1. socket selection
  2. PEQ
  3. gait speed

Secondary Outcome Measures :
  1. gait kinematics
  2. gait kinetics
  3. energy consumption


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Publications:
ClinicalTrials.gov Identifier: NCT00061217     History of Changes
Other Study ID Numbers: R01HD038919-02 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 2004

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