Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amputation |
Device: Experimental prosthetic foot (K3 Promoter) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis |
- Change in metabolic cost of transport [ Time Frame: 30 and 60 days after the beginning of the protocol ] [ Designated as safety issue: No ]
- Stride time variability [ Time Frame: 30 and 60 days after beginning of protocol ] [ Designated as safety issue: No ]
- Amputee Mobility Predictor Questionnaire [ Time Frame: Beginning and end of protocol ] [ Designated as safety issue: No ]
- Actual change in activity as measured by a step counter [ Time Frame: throughout protocol (60 days) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Congenital/Traumatic
Individuals who were born with a limb deficiency or who have had a traumatic amputation.
|
Device: Experimental prosthetic foot (K3 Promoter)
Experimental prosthetic foot
|
|
Experimental: Dysvascular/Diabetic
Individuals who have had an amputation as a result of vascular disease.
|
Device: Experimental prosthetic foot (K3 Promoter)
Experimental prosthetic foot
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- K2 or K3 classification based on current prosthetic device.
- Males and females ≥ 18 years of age
- Willing and able to sign informed consent
- Able to read, write, and speak English
- Documented to have a unilateral trans-tibial amputation
- Actively utilizing a definitive prosthesis for at least 12 months
- Utilizing current prosthetic foot for at least 3 months
- Cognitively functional, in the opinion of the prosthetists'
- Able to maintain a good gait on their existing limb for approximately 45 minutes
- have a healthy residual limb in good condition
- have a socket with a good, trouble-free fit on their residual limb
Exclusion Criteria:
- Significant ulcers or infections associated with a compromised circulation of the other lower limb
- Intermittent Claudication or Critical Leg Ischemia in the non-amputated leg
- K0, K1or K4 Classification
- Irreducible, pronounced knee or hip flexion contractures
- Bilateral amputations
- Use of a walker for ambulation
- 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
- 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
- Advanced neurologic disorder
- Severe congestive heart failure, angina pectoris, or obstructive pulmonary disease
- Use of medication that causes impaired balance or judgment
Contacts and Locations| Contact: Jerome Rifkin, MS ME | 303-666-7722 | jrifkin@tenspro.com |
| United States, Colorado | |
| University of Colorado Gait Lab | Not yet recruiting |
| Boulder, Colorado, United States, 80310 | |
| Contact: Rodger Kram, Ph.D. 303-492-7984 Rodger.Kram@colorado.edu | |
| Principal Investigator: Jerome Rifkin, MS | |
| Principal Investigator: | Jerome Rifkin, MS ME | Tensegrity Prosthetics |
More Information
No publications provided
| Responsible Party: | Jerome Rifkin/CEO & CTO, Tensegrity Prosthetics |
| ClinicalTrials.gov Identifier: | NCT00888199 History of Changes |
| Other Study ID Numbers: | 1-Rifkin |
| Study First Received: | April 23, 2009 |
| Last Updated: | April 24, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tensegrity Prosthetics:
|
amputation amputee prosthetic foot |
prosthesis Tensegrity Prosthetics K3 Promoter |
ClinicalTrials.gov processed this record on May 19, 2013