Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees
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|ClinicalTrials.gov Identifier: NCT01004926|
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : April 15, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Unilateral Trans Tibial Amputation||Device: Echelon foot||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||July 2010|
Device: Echelon foot
One Echelon foot for each subject, for a period of a month.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004926
|Sheba Medical Center|
|Ramat- Gan, Israel|
|Principal Investigator:||Itzhak Siev- Ner, MD||Sheba Medical Center|