Unilateral Trans Tibial Amputation Clinical Trial
Official title:
Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | July 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 20 Years to 70 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sheba Medical Center | Ramat- Gan |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Beginning of the trial and one month after | No | |
| Secondary | Using the Echelon foot the Kinematic of level ground walking and climbing up and down stairs will be closer to normal curves. | At the beginning of the trial and one month later | No |