NCT07486063 Motorized Prostheses for Lower-limb Amputees
| NCT ID | NCT07486063 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Utah |
| Condition | Lower-Limb Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2031-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-07-01 with a primary completion date of 2031-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Tommaso Lenzi, PhD
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT07486063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lower-Limb Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07486063 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07486063 currently recruiting?
Yes, NCT07486063 is actively recruiting participants. Contact the research team at t.lenzi@utah.edu for enrollment information.
Where is the NCT07486063 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT07486063 clinical trial?
NCT07486063 is sponsored by University of Utah. The principal investigator is Tommaso Lenzi, PhD at University of Utah. The trial plans to enroll 40 participants.