NCT00888199

Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tensegrity Prosthetics · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Experimental prosthetic foot (K3 Promoter)	Experimental prosthetic foot

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-04-27
• Last updated: 2009-04-27

Locations

1 site across 1 country: United States