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
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Sponsor:
Sheba Medical Center
Information provided by (Responsible Party):
Dr. Itzhak Siev-Ner, Sheba Medical Center
Tracking Information | ||||
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First Submitted Date ICMJE | October 19, 2009 | |||
First Posted Date ICMJE | October 30, 2009 | |||
Last Update Posted Date | April 15, 2016 | |||
Study Start Date ICMJE | October 2009 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] | |||
Original Primary Outcome Measures ICMJE |
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: Begining of the trial and one month after ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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 ] | |||
Original Secondary Outcome Measures ICMJE |
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 begining of the trial and one month later ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees | |||
Official Title ICMJE | Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial | |||
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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Unilateral Trans Tibial Amputation | |||
Intervention ICMJE | Device: Echelon foot
One Echelon foot for each subject, for a period of a month.
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Study Arms ICMJE | Experimental: Echelon
Intervention: Device: Echelon foot
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
10 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2010 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Israel | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01004926 | |||
Other Study ID Numbers ICMJE | SHEBA-09-7325-IS-CTIL | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Dr. Itzhak Siev-Ner, Sheba Medical Center | |||
Study Sponsor ICMJE | Sheba Medical Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sheba Medical Center | |||
Verification Date | April 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |