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

Sheba Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Unilateral Trans Tibial Amputation

Treatments: Device: Echelon foot

Study type: Interventional

Funder types: Other

Identifiers

NCT01004926

SHEBA-09-7325-IS-CTIL

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Echelon

Experimental group

Treatment:

Device: Echelon foot