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CompletedNCT01004926Updated Apr 15, 2016

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

A Phase 1/2 interventional study of Echelon foot in Unilateral Trans Tibial Amputation, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to male participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-04-15.

Sponsored by Sheba Medical Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Unilateral Trans Tibial Amputation

Keywords

  • Unilateral trans-tibial amputees
03

In context

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Bilateral amputation.
  • Injury of the sound limb that compromises the gait of the amputee.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Echelon

    Device: Echelon foot

Interventions

  • DeviceEchelon foot

    One Echelon foot for each subject, for a period of a month.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Sheba Medical Center
    Ramat- Gan, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01004926
Lead sponsor
Sheba Medical Center
Responsible party
Dr. Itzhak Siev-Ner (Dr. Itzhak Siev-Ner, Sheba Medical Center) — Principal investigator
First posted
Oct 30, 2009
Start date
Oct 2009
Primary completion
Mar 2010
Completion
Jul 2010
Last update
Apr 15, 2016

Study contacts

Itzhak Siev- Ner, MD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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