Hybrid Prosthetic Leg for Amputation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new type of prosthetic leg called the Hybrid Leg. The goal is to determine if this lightweight, powered leg can enhance the lives of people with lower limb amputations by evaluating its use in both lab settings and daily life. Participants will either try the Hybrid Leg or continue using their current prosthetic leg. Ideal candidates for the trial are those who have had one or both legs amputated and are already using a prosthesis for mobility. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve mobility solutions for amputees.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the Hybrid Prosthetic Leg is safe?
Research has shown that robotic prostheses, such as the Hybrid Leg, help people walk faster and with less effort. These devices are generally safe, especially when tested and used in controlled settings. Users of these prosthetic legs have a lower chance of falling compared to some other types of prosthetic knees. As a result, the Hybrid Leg is well-accepted and may offer a safer experience for users.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the Hybrid Leg because it combines advanced technology to improve mobility for amputees. Unlike traditional passive prosthetic legs, which rely on the user's own motion to function, the Hybrid Leg integrates active components that can provide powered assistance and more natural movement. This innovative approach could lead to better balance, increased walking speed, and reduced fatigue for users, making daily activities easier and more comfortable.
What evidence suggests that this trial's prosthetic legs could be effective for amputation?
Research has shown that robotic prostheses like the Hybrid Leg, which participants in this trial may receive, help people walk faster and use less energy. Studies also indicate that these devices lower the risk of falling. The Hybrid Leg employs advanced controls to make walking smoother and more natural. Recent improvements in smart prosthetic limbs allow them to adjust to different walking speeds and needs. This technology aims to make walking more efficient and safe for users. Meanwhile, another group in this trial will use their currently prescribed passive prosthesis, serving as a comparison to evaluate the benefits of the Hybrid Leg.13678
Who Is on the Research Team?
Levi Hargrove, PhD
Principal Investigator
Shirley Ryan AbilityLab
Are You a Good Fit for This Trial?
This trial is for individuals with a single or double lower limb amputation who currently use a prosthesis and can walk at various speeds (K2/K3/K4 level). Participants must speak English to understand the study and give feedback. Those with cognitive impairments, other serious health issues, or new injuries that prevent prosthesis use cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
In-lab Therapy
Participants are fit with the Hybrid Leg and receive in-lab therapy to learn how to ambulate with the device
Ambulation and Community Mobility Training
Subjects complete extensive ambulation and community mobility training to learn optimal use of their own passive device or the Hybrid Leg
Home Trial
Subjects complete 4-week trials using their assigned prosthesis (Condition A or B) at home and within their community
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hybrid Leg
- Prescribed Passive Prosthesis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shirley Ryan AbilityLab
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator