No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
40 (estimated)
Sponsor
University of Utah · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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
Ou…
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
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