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

NCT ID: NCT01004926

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Unilateral Trans Tibial Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Echelon

Group Type EXPERIMENTAL

Echelon foot

Intervention Type DEVICE

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

Interventions

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Echelon foot

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Itzhak Siev-Ner

Dr. Itzhak Siev-Ner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Itzhak Siev- Ner, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-09-7325-IS-CTIL

Identifier Type: -

Identifier Source: org_study_id

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