RecruitingEarly Phase 1NCT07486063
Motorized Prostheses for Lower-limb Amputees
Lightweight Motorized Prostheses for Lower-limb Amputees
Sponsor
University of Utah
Enrollment
40 participants
Start Date
Jul 1, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria6
- 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
Exclusion Criteria8
- 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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Interventions
DEVICEPowered and passive lower limb prosthesis and control
Effect of prosthesis function on mobility and ambulation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07486063
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