Motorized knee and ankle prostheses for people with above-knee amputations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with unilateral above-knee amputation will complete repeated laboratory sessions using their usual passive prosthesis and a lightweight powered knee paired with powered, semi-active, and passive ankle configurations under different volitional controllers. Testing includes level and inclined treadmill walking at self-selected speeds to measure residual limb hip torque, contralateral effort, gait symmetry, and balance, as well as instrumented stair ascent and descent to measure prosthesis and residual limb work and upper-body effort. Each tested condition includes familiarization and a training session, and participants will rate intuitiveness, safety, and physical and mental demand with a 5-point questionnaire. Data will compare biomechanics and functional mobility across device and controller combinations to identify configurations that reduce effort or improve performance.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Tommaso Lenzi, PhD — University of Utah
• Study coordinator: Tommaso Lenzi, PhD
• Email: t.lenzi@utah.edu
• Phone: 3126190442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.