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

• ClinicalTrials.gov Identifier: NCT01004926
• Recruitment Status: Completed
• First Posted: October 30, 2009
• Last Update Posted: April 15, 2016
• Sponsor: Sheba Medical Center
• Information provided by (Responsible Party): Dr. Itzhak Siev-Ner, Sheba Medical Center

Tracking Information

• First Submitted Date: October 19, 2009
• First Posted Date: October 30, 2009
• Last Update Posted Date: April 15, 2016
• Study Start Date: October 2009
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures (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 (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: Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Unilateral Trans Tibial Amputation

Intervention

Device: Echelon foot

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

Study Arms

Experimental: Echelon

Intervention: Device: Echelon foot

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 29, 2009): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT01004926
• Other Study ID Numbers: SHEBA-09-7325-IS-CTIL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Itzhak Siev-Ner, Sheba Medical Center
• Study Sponsor: Sheba Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Itzhak Siev- Ner, MD; Sheba Medical Center

• PRS Account: Sheba Medical Center
• Verification Date: April 2016