MIT Powered Leg for Below Knee Amputation

Overseen By John A McCullough, B.S. Mechanical Engineering

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Institute of Technology

Disqualifiers: Pregnancy, Severe comorbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new bionic leg, the MIT Powered Leg, designed to help individuals with below-knee amputations move more naturally and comfortably. The goal is to evaluate how well this advanced prosthesis performs in real-world situations compared to regular prosthetics. Researchers aim to understand how the bionic leg affects walking balance and the sensation of the leg being a natural part of the body. Individuals with a below-knee amputation who can walk at various speeds and have a well-fitting prosthetic socket might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to cutting-edge research and potentially enhance prosthetic technology for future users.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this device is safe for below knee amputation?

Research shows that the MIT Powered Leg is designed to assist individuals with below-knee amputations. It aims to restore natural movement, making walking and climbing stairs easier. Users of similar bionic limbs have demonstrated promising results, with improved walking patterns and greater control over their movements.

The current study tests the effectiveness and adaptability of the powered leg. Although this is an experimental treatment, past studies have not reported any major side effects, suggesting that the MIT Powered Leg is generally well-tolerated. However, as research continues, more detailed information about its safety will become available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MIT Powered Leg is unique because it integrates advanced robotics to create a powered knee-ankle prosthesis, offering a more dynamic and responsive experience for individuals who have undergone below-knee amputation. Unlike standard prostheses, which are typically passive and rely on the user's own energy for movement, the MIT Powered Leg actively assists with walking, making it easier to navigate various terrains. Researchers are excited about this treatment because it has the potential to significantly enhance mobility and comfort, providing a more natural gait and reducing the effort required by the user compared to conventional prosthetic options.

What evidence suggests that the MIT Powered Leg is effective for below knee amputation?

Research has shown that the MIT Powered Leg, available to participants in this trial, can help individuals with below-knee amputations walk more naturally. In one study, users of this advanced leg walked faster and more like those without amputations. Controlled by the nervous system, the leg aids users in maintaining better balance and control. Early results indicate that users manage everyday tasks more effectively than with their usual prosthetic legs. These findings offer hope for improved movement and easier daily life for those with lower-limb amputations. ^{1 3 4 5 6}

Who Is on the Research Team?

Hugh Herr

Principal Investigator

MIT Media Lab

Are You a Good Fit for This Trial?

This trial is for individuals with a below-knee amputation who are interested in testing a new bionic prosthesis called the MIT Powered Leg. Participants should be able to perform diverse mobility tasks and must have been using their current prescribed prosthesis regularly.

Inclusion Criteria

My body can properly support the medical device.

I am between 18 and 70 years old.

I have had one leg amputated above the knee.

Exclusion Criteria

Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.)

I am not pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are evaluated on the performance and adaptability of a neural-controlled powered knee or ankle prosthesis across diverse real-world mobility tasks.

1 week

2 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MIT Powered Leg

Trial Overview The study tests the MIT Powered Leg, focusing on its performance during various real-world tasks. It compares users' sense of embodiment, walking symmetry, and stability against their usual prostheses to inform future bionic limb design.

How Is the Trial Designed?

Group I: MIT Powered Leg Experimental Treatment 1 Intervention

Subjects wears the MIT powered knee-ankle prosthesis.

Group II: Prescribed prosthesis Active Control 1 Intervention

Subjects wears their prescribed prosthesis.

Who Is Running the Clinical Trial?

Massachusetts Institute of Technology

Lead Sponsor

Trials

104

Recruited

12,810,000+

Citations

1. news.mit.edu news.mit.edu/2025/bionic-knee-integrated-into-tissue-can-restore-natural-movement-0710

A bionic knee integrated into tissue can restore natural ... In a 2024 study, the researchers showed that people with amputations below the knee who received the AMI surgery were able to walk faster and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11271427/

Continuous neural control of a bionic limb restores biomimetic ... Our previous reports demonstrated that the below-knee AMI amputation improves volitional free-space control in a benchtop setting. Preliminary ...

3. news.mit.edu news.mit.edu/2024/prosthesis-helps-people-with-amputation-walk-naturally-0701

A prosthesis driven by the nervous system helps people ... ... MIT researchers restored a natural walking gait in people with amputations below the knee. Seven patients were able to walk faster, avoid ...

4. withpower.com withpower.com/trial/phase-transfemoral-amputation-4-2025-9d5b1

MIT Powered Leg for Below Knee Amputation The purpose of this study is to evaluate the performance and adaptability of a neural-controlled powered knee or ankle prosthesis across diverse real-world ...

5. dspace.mit.edu dspace.mit.edu/bitstream/handle/1721.1/163444/petelina-petelina-meche-phd-2025-thesis.pdf?sequence=1&isAllowed=y

Integrated Prosthetic Leg Design Frameworks for People ... Though people with below-knee amputation are capable of restoring close-to able-bodied mobility [26, 29, 36], achieving similar results in the ...

6. nature.com nature.com/articles/s41551-020-00619-3

Design and clinical implementation of an open-source ... Scalable: the knee and ankle joints can operate independently, enabling research in patients with above-knee and below-knee amputations. (4).