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

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.

Study Overview

• Status: Unknown
• Conditions: Amputation
• Intervention / Treatment: Device: adaptive prosthetic socket

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus
    • SAFE LLC
• United States
  • New York
    • New York, New York, United States, 11023
      • George Papaioannou Ph.d
  • Wisconsin
    • Milwaukee, New York, Nicosia, Wisconsin, United States, 53211
      • Safe Llc Move Center and Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• trans-tibial amputation, proficiency in prosthesis use

Exclusion Criteria:

• pregnancy, balance impairment, stump skin breakdown

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: SMART socket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in skin/socket displacement with different prosthetic sockets	one (1) year -baseline end of first year i.e. end of 2010 - with measurements at sixth and twelveth month

Collaborators and Investigators

• Sponsor: University of Wisconsin, Milwaukee
• Investigators: Principal Investigator: George Papaioannou, Ph.D, SAVE LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: March 22, 2010
• First Submitted That Met QC Criteria: April 21, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Estimate): August 1, 2012
• Last Update Submitted That Met QC Criteria: July 30, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: prosthetics; socket comfort; amputation stump; amputee rehabilitation
• Other Study ID Numbers: CPSHI/IRB 00002053