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Recruiting
NCT07486063
Motorized Prostheses for Lower-limb Amputees
Conditions: Lower-Limb Amputation
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 40
Sponsor: University of Utah
Location: University of Utah Salt Lake City Utah
Summary
The investigators will assess biomechanical and functional mobility outcomes in individuals with unilateral, above-knee amputations using different knee/ankle configurations of a lightweight powered prosthesis and different volitional controllers in individuals with unilateral, above-knee amputations.
Eligibility Criteria
Our inclusion criteria will be
* Above-knee amputation
* K2/K3/K4 ambulators
* At least 18 years old
* At least one year since amputation
* At least six months since the definitive prosthesis fitting
* Currently prescribed and using a mechanically passive or microprocessor-controlled prosthesis
Our exclusion criteria will be
* Over 350 lbs. body weight, the weight limit for our safety suspension systems
* Cognitive deficits or visual impairment that could impair their ability to give informed consent or to follow simple instructions during the experiments
* Pregnant women due to elevated safety concerns for this population
* Co-morbidity that limits their ability to participate in the study protocol (e.g., stroke, pacemaker placement that would interfere with the powered prosthesis, severe ischemia, cardiac disease, etc.)
* Adults who are unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Individuals who use a wheelchair for mobility both outdoors and indoors because they may not be able to perform the necessary activities with their passive prosthesis or the powered prosthesis
* Prisoners, due to concerns with informed consent
Source: ClinicalTrials.gov (NCT07486063). StuddyBuddy aggregates publicly available trial information.