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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Itzhak Siev-Ner, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01004926
First received: October 19, 2009
Last updated: April 14, 2016
Last verified: April 2016
  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:


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: Beginning 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 beginning of the trial and one month later ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: March 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   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01004926

Locations
Israel
Sheba Medical Center
Ramat- Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Itzhak Siev- Ner, MD Sheba Medical Center
  More Information

Responsible Party: Dr. Itzhak Siev-Ner, 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: April 14, 2016
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on July 28, 2016