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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01004926
Enrollment
10
Registered
2009-10-30
Start date
2009-10-31
Completion date
2010-07-31
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Trans Tibial Amputation

Keywords

Unilateral trans-tibial amputees

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.

Interventions

DEVICEEchelon foot

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

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 70 Years
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

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

Design outcomes

Primary

MeasureTime 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.Beginning of the trial and one month after

Secondary

MeasureTime frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026