Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees

April 14, 2016 updated by: Dr. Itzhak Siev-Ner, Sheba Medical Center

Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial

The aim of this work was to test the Echelon foot efficiency to offer enhanced safety, comfort and function over a wide range of walking surfaces, inclines and stairs, thereby improving the quality of life for amputees.

Ten individuals with a unilateral trans- tibial amputation will participate in two test sessions- one while using their own prosthetic foot, the other while using the Echelon foot.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat- Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Ten individuals with a unilateral trans tibial amputation due to trauma.
  • Walking at list one year from the end of their gait training. Mobility status is 3 or 4.

Exclusion Criteria:

  • Bilateral amputation.
  • Injury of the sound limb that compromises the gait of the amputee.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Echelon
Device: Echelon foot
One Echelon foot for each subject, for a period of a month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
While using the Echelon foot the amputees will present lower internal mechanical strain in the soft tissue of the stump while standing on a 10 degrees platform.
Time Frame: Beginning of the trial and one month after
Beginning of the trial and one month after

Secondary Outcome Measures

Outcome Measure
Time Frame
Using the Echelon foot the Kinematic of level ground walking and climbing up and down stairs will be closer to normal curves.
Time Frame: At the beginning of the trial and one month later
At the beginning of the trial and one month later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Itzhak Siev- Ner, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHEBA-09-7325-IS-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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