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

Phase 1
Completed
Conditions
Unilateral Trans Tibial Amputation
Interventions
Device: Echelon foot
Registration Number
NCT01004926
Lead Sponsor
Sheba Medical Center
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
10
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
EchelonEchelon foot-
Primary Outcome Measures
NameTimeMethod
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.Beginning of the trial and one month after
Secondary Outcome Measures
NameTimeMethod
Using the Echelon foot the Kinematic of level ground walking and climbing up and down stairs will be closer to normal curves.At the beginning of the trial and one month later

Trial Locations

Locations (1)

Sheba Medical Center

🇮🇱

Ramat- Gan, Israel

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