Stability and 3D Motion Study of an Experimental Prosthetic Foot

Status unconfirmed · Phase 3

Conditions studied: Amputation

In brief

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

Key facts

Study ID

NCT00968292

Run by

Tensegrity Prosthetics

People needed

50

Starts

2010-05-01

Expected to finish

2010-08-01

Last updated by the study team

2009-08-28

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Gait and Movement Analysis — Arvada, Colorado, United States

Full record on ClinicalTrials.gov

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