Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

NCT ID: NCT00888199

Last Updated: 2009-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Congenital/Traumatic

Individuals who were born with a limb deficiency or who have had a traumatic amputation.

Group Type: EXPERIMENTAL

Experimental prosthetic foot (K3 Promoter)

Intervention Type: DEVICE

Experimental prosthetic foot

Dysvascular/Diabetic

Individuals who have had an amputation as a result of vascular disease.

Group Type: EXPERIMENTAL

Experimental prosthetic foot (K3 Promoter)

Intervention Type: DEVICE

Experimental prosthetic foot

Interventions

Experimental prosthetic foot (K3 Promoter)

Experimental prosthetic foot

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. K2 or K3 classification based on current prosthetic device.

2. Males and females ≥ 18 years of age

3. Willing and able to sign informed consent

4. Able to read, write, and speak English

5. Documented to have a unilateral trans-tibial amputation

6. Actively utilizing a definitive prosthesis for at least 12 months

7. Utilizing current prosthetic foot for at least 3 months

8. Cognitively functional, in the opinion of the prosthetists'

9. Able to maintain a good gait on their existing limb for approximately 45 minutes

10. have a healthy residual limb in good condition

11. have a socket with a good, trouble-free fit on their residual limb

Exclusion Criteria

1. Significant ulcers or infections associated with a compromised circulation of the other lower limb

2. Intermittent Claudication or Critical Leg Ischemia in the non-amputated leg

3. K0, K1or K4 Classification

4. Irreducible, pronounced knee or hip flexion contractures

5. Bilateral amputations

6. Use of a walker for ambulation

7. Severe arthritis that would limit the ability to stand without pain or discomfort or the subject's ability to ambulate is limited by symptoms other than the prothesis (e.g., shortness of breath, fatigue, angina, arthritis, etc.). If, in the opinion of the investigator, the subject were to improve their ability to ambulate from the K3 Promoter to the extent that his or her walking would then be limited by a symptom other than the prothesis, the subject should not be enrolled

8. Any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial

9. Advanced neurologic disorder

10. Severe congestive heart failure, angina pectoris, or obstructive pulmonary disease

11. Use of medication that causes impaired balance or judgment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Tensegrity Prosthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Tensegrity Prosthetics

Principal Investigators

Jerome Rifkin, MS ME

Role: PRINCIPAL_INVESTIGATOR

Tensegrity Prosthetics

Locations

University of Colorado Gait Lab

Boulder, Colorado, United States

Countries

United States

Central Contacts

Jerome Rifkin, MS ME

Role: CONTACT

jrifkin@tenspro.com

303-666-7722

Facility Contacts

Rodger Kram, Ph.D.

Role: primary

Rodger.Kram@colorado.edu

303-492-7984

Other Identifiers

1-Rifkin

Identifier Type: -

Identifier Source: org_study_id