Status:
UNKNOWN
Stability and 3D Motion Study of an Experimental Prosthetic Foot
Lead Sponsor:
Tensegrity Prosthetics
Conditions:
Amputation
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief 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 cur...
Detailed 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...
Eligibility Criteria
Inclusion
- 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 their prosthetist
- Able to walk on their existing limb
- Have a healthy residual limb in good condition
- Have a socket with a good, trouble-free fit on their residual limb
Exclusion
- 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 will 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00968292
Start Date
May 1 2010
End Date
August 1 2010
Last Update
August 28 2009
Active Locations (1)
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1
Center for Gait and Movement Analysis
Arvada, Colorado, United States, 80045