Motorized Prostheses for Lower Limb Amputation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different motorized prostheses, specifically powered lower limb prostheses, affect movement and balance in people with above-knee amputations. Researchers test various knee and ankle configurations to determine which provide the best mobility. Participants must have had an above-knee amputation at least a year ago and already use a prosthetic leg. As an Early Phase 1 trial, this research focuses on understanding how these prostheses function in people, offering participants the opportunity to experience innovative mobility solutions.
What prior data suggests that this powered lower limb prosthesis is safe?
Research has shown that powered lower limb prostheses, like those being studied, are generally well-received by users. Powered prosthetic ankles, for instance, use battery power to ease walking, particularly for individuals who have lost a lower limb. This can make movement feel more natural and less tiring.
Previous studies have examined the safety and effectiveness of these prosthetics. Users have reported positive experiences, noting improved mobility and stability. However, as this trial is in its early stages, some unknown side effects or risks may still exist.
It is important to remember that these prostheses are still under testing, so participating in trials helps gather more information on their safety. Participants play a crucial role in helping researchers understand how these devices function in everyday life.12345Why do researchers think this study treatment might be promising?
Researchers are excited about powered lower limb prostheses because they offer enhanced mobility and functionality compared to traditional passive prosthetics. Unlike passive prostheses, which rely on the user's remaining muscle strength and momentum, powered prostheses feature motorized joints that assist in movement, allowing for a more natural walking pattern and reducing the effort required from the user. This innovation is especially promising for individuals with lower limb amputations, as it has the potential to improve balance, reduce fatigue, and enhance overall quality of life.
What evidence suggests that this powered lower limb prosthesis is effective for individuals with above-knee amputations?
Research has shown that powered prosthetic legs can greatly improve movement for people with above-knee amputations. Many participants report that these legs make daily activities, such as walking indoors and using the bathroom, easier. This trial will evaluate both powered and passive lower limb prostheses. Studies indicate that powered prosthetic legs help people walk better than non-powered ones, especially active individuals with below-knee amputations. However, the benefits for other groups remain less certain. Despite being heavier due to additional features, these devices show promise in enhancing movement and function.12367
Who Is on the Research Team?
Tommaso Lenzi, PhD
Principal Investigator
University of Utah
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Training
Participants familiarize themselves with the protocol and prosthesis in dedicated training sessions
Experimental Protocols
Participants undergo various experimental protocols to assess biomechanical and functional mobility outcomes using different prosthesis configurations
Follow-up
Participants are monitored for safety and effectiveness after completing the experimental protocols
What Are the Treatments Tested in This Trial?
Interventions
- Powered Lower Limb Prosthesis
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Powered and passive lower limb prosthesis and control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
The influence of powered prostheses on user perspectives ...
The efficacy of powered ankles has been shown in active, high functioning individuals with transtibial amputation, but is less clear in other populations.
Outcomes of Patients with Lower Limb Loss after Using a ...
The aim of this retrospective case series study was to investigate outcomes in patients with lower limb loss based on whether or not they used a training ...
A Review of Current State-of-the-Art Control Methods ... - PMC
First, powered lower-limb prostheses tend to have increased weight compared to microprocessor or passive prostheses due to the addition of sensing, actuation, ...
Powered Prosthesis for Amputation · Info for Participants
Research has shown that powered prosthetic legs can significantly enhance mobility for individuals with above-knee amputations. This trial will have ...
Virtual Assessment of Functional Mobility in Lower ...
Results. Most participants reported significant ease of completing basic indoor ambulation and toileting tasks (66%-75%) and significant difficulty in running ...
Motorized Prostheses for Lower-limb Amputees
The primary outcome of the first study will be residual limb effort measured through peak hip flexion torque on the prosthesis side. Secondary ...
Stability and Falls Evaluations in AMPutees (SAFE-AMP 2) ...
The purpose of this study was to identify factors associated with a history of injurious falls among LLP users using a clinical outcomes database.
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