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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Amputation Device: adaptive prosthetic socket Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : January 2011
Actual Primary Completion Date : June 2012
Estimated Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: adaptive trans-tibial socket
subjects are fitted with experimental sockets.
Device: adaptive prosthetic socket
trans tibial socket with actuator zones (inflatable fluid bladders)
Other Name: SMART socket

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • trans-tibial amputation, proficiency in prosthesis use

Exclusion Criteria:

  • pregnancy, balance impairment, stump skin breakdown

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 identifier (NCT number): NCT01108536

United States, New York
George Papaioannou Ph.d
New York, New York, United States, 11023
United States, Wisconsin
Safe Llc Move Center and Laboratories
Milwaukee, New York, Nicosia, Wisconsin, United States, 53211
Nicosia, Cyprus
Sponsors and Collaborators
University of Wisconsin, Milwaukee
Principal Investigator: George Papaioannou, Ph.D SAVE LLC

Responsible Party: Yiorgos, Dr., University of Wisconsin, Milwaukee Identifier: NCT01108536     History of Changes
Other Study ID Numbers: CPSHI/IRB 00002053
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by Yiorgos, University of Wisconsin, Milwaukee:
socket comfort
amputation stump
amputee rehabilitation