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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01004926
First received: October 19, 2009
Last updated: October 29, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Unilateral Trans Tibial Amputation
 Device: Echelon foot
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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: Begining of the trial and one month after ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 begining of the trial and one month later ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Echelon Device: Echelon foot
One Echelon foot for each subject, for a period of a month.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004926

Contacts
Contact: Anat Kristal, Msc. P.T. 00972-35739546 anatkristal@gmail.com

Locations
Israel
Sheba Medical Center Not yet recruiting
Ramat- Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Itzhak Siev- Ner, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Siev- Ner Itzhak, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01004926     History of Changes
Other Study ID Numbers: SHEBA-09-7325-IS-CTIL
Study First Received: October 19, 2009
Last Updated: October 29, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Unilateral trans-tibial amputees

ClinicalTrials.gov processed this record on May 22, 2013