Dynamic Management of Excess Residual Limb Pressure With New Smart Socket Technology/Intelligent Prosthetic Socket With Variable Volume and Elevated Vacuum Systems (SMARTsocket-)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01108536
Recruitment Status : Unknown
Verified July 2012 by Yiorgos, University of Wisconsin, Milwaukee.
Recruitment status was:  Active, not recruiting
First Posted : April 22, 2010
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
Yiorgos, University of Wisconsin, Milwaukee

March 22, 2010
April 22, 2010
August 1, 2012
January 2011
June 2012   (Final data collection date for primary outcome measure)
Change in skin/socket displacement with different prosthetic sockets [ Time Frame: one (1) year -baseline end of first year i.e. end of 2010 - with measurements at sixth and twelveth month ]
Same as current
Complete list of historical versions of study NCT01108536 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Dynamic Management of Excess Residual Limb Pressure With New Smart Socket Technology/Intelligent Prosthetic Socket With Variable Volume and Elevated Vacuum Systems
Dynamic Management of Excess Residual Limb Pressure With New Smart Socket Technology/Intelligent Amputee Sockets Employing Real Time Advanced Photonic Sensors for Optimum Fit and Pressure Relief Through Active Controls/Intelligent Prosthetic Socket With Variable Volume and Elevated Vacuum Systems

This study centers around the imaging of internal structures of residual limb by means of modern radiographic imaging techniques (Dynamic Radiography-DRSA).

The purpose of our research is to further study the behavior of bones and soft tissue of the socket-stump interface during dynamic tasks such as walking or brisk walking. In the long term this research could prove a basis for improvements in the general design of sockets for the new generation of prosthetic devices.

There is very little known about the dynamic conditions inside a prosthetic socket, despite several research efforts based on pressure sensors, static X-ray images and/or computer simulations (FEM). The man reason is the inability of current measuring devices to track with enough resolution the in-vivo high speed kinematics of the stump-socket interface. Socket manufacturing and rectification in the field still relies on the experience and skill of the technician and feedback from the patient. This results in considerable dissatisfaction among the users and poor quantification of the socket fitting problems.

For lower extremity amputees, a well-fitting socket is an important element for a successful rehabilitation. The socket provides the interface between the prosthesis and residual limb, which is designed to provide comfort, appropriate load transmission, and efficient movement control. Attaining these objectives is extremely challenging, with up to 55% of lower limb amputees reporting dissatisfaction with socket comfort, residual limb pain, and/or skin breakdown. In addition, current techniques used to produce sockets with suitable characteristics are labor and cost intensive, and depend on the work of skilled prosthetists that are relatively scarce compared to the number of amputees. Currently, there are more than 500,000 lower limb amputees in the U.S. alone, with 60,000 new ones every year. For upper extremity amputees the issues related to the efficiency of movement, load transmission and comfort become even more challenging due to the different nature of the associated motor skills and performing tasks. Similarly there are l7,350 annual upper limb amputations distal to elbow in individuals under 21 years of age in the US. In most developed countries there are 1.55 amputees per 1000 people. Most amputees wear a prosthesis for about 70 hr/week and use crutches or wheelchairs as alternative assistive devices when performing certain tasks. Current solutions do not meet the patient specific needs.

It is suggested that our findings can further the understanding of the effects of slippage or harmful relative motion between stump and socket. Eventually new - and scientific based - guidelines for the fitting of artificial limbs could be recommended.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Device: adaptive prosthetic socket
trans tibial socket with actuator zones (inflatable fluid bladders)
Other Name: SMART socket
Experimental: adaptive trans-tibial socket
subjects are fitted with experimental sockets.
Intervention: Device: adaptive prosthetic socket
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
August 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • trans-tibial amputation, proficiency in prosthesis use

Exclusion Criteria:

  • pregnancy, balance impairment, stump skin breakdown
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Cyprus,   United States
CPSHI/IRB 00002053
Not Provided
Not Provided
Yiorgos, University of Wisconsin, Milwaukee
University of Wisconsin, Milwaukee
Not Provided
Principal Investigator: George Papaioannou, Ph.D SAVE LLC
University of Wisconsin, Milwaukee
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP