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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01004926
• Date of registration: 19/10/2009
• Primary sponsor: Sheba Medical Center
• Public title: Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees
• Scientific title: Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial
• Date of first enrolment: October 2009
• Target sample size: 10
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01004926
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Israel

Contacts

• Name: Anat Kristal, Msc. P.T.

• Name: Itzhak Siev- Ner, MD
• Affiliation: Sheba Medical Center

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 70 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Unilateral Trans Tibial Amputation

Intervention(s)

Device: Echelon foot

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

SHEBA-09-7325-IS-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors