Stability and 3D Motion Study of an Experimental Prosthetic Foot

Amputation Clinical Trial

Official title: Stability & 3D Motion Study of an Experimental Prosthetic Foot

Status Not yet recruiting

Clinical Trial Summary

The investigators are currently verifying early data showing that the K3 Promoter prosthetic foot affects walking efficiency or stability in transtibial, unilateral amputees when compared to their current prostheses. Phase II funds are being used to address these metrics. These studies are important basic research, however, while Tensegrity has the unique opportunity to study amputee gait and movement in the CGMA's state-of-the-art facility the investigators will expand these studies with BRDG-SPAN funding by studying the following metrics:

1. Four Square Step Test (FSST)

2. Amputee Mobility Predictor (AMP)

3. Timed Up and Go Test (TUG)

4. Quality of life (QOL) index (SF-36)

5. Activity-specific Balance Confidence Questionnaire (ABC)

6. 3D motion analysis

Clinical Trial Description

The tests will be unblinded randomized studies of the subject's current prosthetic foot and the K3 Promoter on traumatic/congenital amputees and dysvascular/diabetic amputees. Assessments will be made after a 30-day accommodation period with each foot prosthesis. In order to randomize the treatment and factor out habituation to the testing site and the protocol, two cohorts will be used. Half of the volunteers will be randomly assigned to be fitted with the K3 Promoter by their regular prosthetist or will continue wearing their current foot prothesis. Both cohorts will have a 30-day accommodation period. Subjects in either cohort will then visit the CGMA to be tested. Volunteers will then use the other prosthesis for 30 days. After that second 30-day period, height and weight will again be recorded, and the tests will be repeated. Because of anticipated difficulty with scheduling, volunteers will be given a +3 day grace period on the 30 day-accommodation time. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation

• NCT number: NCT00968292
• Study type: Interventional
• Source: Tensegrity Prosthetics
• Contact: Jerome Rifkin, MS
• Phone: 303 666 7722
• Email: jrifkin@tenspro.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2010
• Completion date: August 2010