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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01004926
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Itzhak Siev-Ner, Sheba Medical Center

Tracking Information
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
 (submitted: April 14, 2016)
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
 (submitted: October 29, 2009)
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
 (submitted: April 14, 2016)
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
 (submitted: October 29, 2009)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Unilateral Trans Tibial Amputation
Intervention  ICMJE Device: Echelon foot
One Echelon foot for each subject, for a period of a month.
Study Arms  ICMJE Experimental: Echelon
Intervention: Device: Echelon foot
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2009)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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
Principal Investigator: Itzhak Siev- Ner, MD Sheba Medical Center
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