Amputation
Conditions
Keywords
amputation, amputee, prosthetic, foot, prosthesis, Tensegrity, Prosthetics, K3 Promoter
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.
Interventions
DEVICEExperimental prosthetic foot (K3 Promoter)
Experimental prosthetic foot
Sponsors
National Institutes of Health (NIH)
Tensegrity Prosthetics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in metabolic cost of transport | 30 and 60 days after the beginning of the protocol |
| Stride time variability | 30 and 60 days after beginning of protocol |
Secondary
| Measure | Time frame |
|---|---|
| Amputee Mobility Predictor Questionnaire | Beginning and end of protocol |
| Actual change in activity as measured by a step counter | throughout protocol (60 days) |
Countries
United States
Contacts
Primary ContactJerome Rifkin, MS ME
Outcome results
None listed