Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

Status Not yet recruiting

Clinical Trial Summary

The purpose of this clinical trial is to determine if the experimental Tensegrity prosthetic foot offers a reduction of the amount of oxygen used while walking, if stability is improved over current prosthetic feet, and whether the experimental device actually increases activity in amputees.

Clinical Trial Description

Tensegrity Prosthetics' objectives are to test whether the K3 Promoter prosthetic foot affects walking efficiency or stability in trans-tibial unilateral amputees when compared to their current prostheses. The primary objectives are to determine if the experimental foot changes Cost of Transport (ml O2/kg/meter) or Stride Time Variability compared to an amputee's current prosthesis. Cost of Transport is an indicator of metabolic efficiency and Stride Time Variability indicates how likely a person is to fall. Oxygen consumption and stride time will be collected on a treadmill at the Gait and Motion Lab at the University of Colorado in Boulder. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Amputation

Clinical Trial Details

NCT number	NCT00888199
Study type	Interventional
Source	Tensegrity Prosthetics
Contact	Jerome Rifkin, MS ME
Phone	303-666-7722
Email	jrifkin@tenspro.com
Status	Not yet recruiting
Phase	Phase 2/Phase 3
Start date	January 2010
Completion date	June 2010

View Details

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