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New treatment option for Lower-Limb Amputation
Official title Motorized Prostheses for Lower-limb Amputees
ClinicalTrials.gov ID: NCT07486063
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Our will be
- Above-knee amputation
- K2/K3/K4 ambulators
- At least 18 years old
- At least one year since amputation
You likely can't join if
- 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...
- 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...
- Adults who are unable to consent
See the full eligibility criteria
- Our 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.