Powered Knee Prosthesis for Above-Knee Amputation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Institute of Technology

Disqualifiers: Pregnancy, Severe comorbidity, Poor health, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

7 Participants Needed

Trial Summary

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 data supports the effectiveness of the MIT Powered Knee treatment for above-knee amputation?

Research shows that powered knee prostheses can help people with above-knee amputations walk more naturally and climb stairs, improving their mobility and quality of life. Studies also indicate that these prostheses can adjust to different walking conditions, making them more comfortable and safer for everyday use. ^{1 2 3 4 5}

Is the powered knee prosthesis safe for humans?

Research shows that powered knee prostheses can improve walking and stair climbing for people with above-knee amputations, and they may enhance mobility and quality of life. However, there is no specific mention of safety concerns or adverse effects in the studies, suggesting they are generally safe for use. ^{2 4 6 7 8}

How does the MIT Powered Knee treatment differ from other treatments for above-knee amputation?

The MIT Powered Knee treatment is unique because it uses a lightweight robotic design that mimics the natural movements of the knee, ankle, and toe, allowing for more natural walking and stair climbing. Unlike traditional passive prostheses, it features energy regeneration and a simplified control system, which helps improve mobility and efficiency without frequent battery charging. ^{2 3 9 10 11}

What is the purpose of this trial?

The purpose of the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment

Research Team

Hugh M Herr, PhD

Principal Investigator

Massachusetts Institute of Technology

Eligibility Criteria

This trial is for individuals who have had a below-knee amputation and are looking to improve their mobility. Participants should be able to walk with a prosthesis and commit to the study requirements. Specific eligibility details, such as age range or health status, are not provided.

Inclusion Criteria

My body can support the medical device properly.

I am between 22 and 65 years old.

I have had one leg amputated above the knee.

Exclusion Criteria

I am currently pregnant.

I do not have severe health issues that would prevent me from being a good candidate for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either their prescribed prosthesis or the MIT powered knee prosthesis to assess clinical and functional outcomes

1 week

2 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MIT Powered Knee

Trial Overview The study is testing the MIT Powered Knee, an advanced prosthetic knee designed to enhance walking and movement control for those with transfemoral amputations. The focus is on how this device affects gait, spatial management, and the user's sense of integration with the prosthesis.

Participant Groups

Group I: MIT Powered Knee Experimental Treatment 1 Intervention

Subjects wears the MIT powered knee 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+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

Findings from Research

In a study involving 41 individuals with above-knee amputations, those with higher functional mobility levels showed significant improvements in performance speed when using microprocessor-controlled prosthetic knee joints compared to mechanically controlled ones.

The results indicate that while there is considerable variability in functional performance among MFCL-2 amputees, many can benefit from the advanced technology of microprocessor-controlled knees for daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional added value of microprocessor-controlled knee joints in daily life performance of Medicare Functional Classification Level-2 amputees. Theeven, P., Hemmen, B., Rings, F., et al.[2014]

A case study demonstrated that lightweight powered knee and ankle prostheses can effectively restore natural leg movements for individuals with bilateral above-knee amputations, allowing them to walk and climb stairs with improved gait patterns.

The powered prostheses were able to replicate essential biomechanical functions, such as ankle push-off during walking and knee power generation during stair ascent, which are crucial for enhancing mobility and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered knee and ankle prostheses enable natural ambulation on level ground and stairs for individuals with bilateral above-knee amputation: a case study. Hood, S., Creveling, S., Gabert, L., et al.[2023]

The new robotic leg prosthesis effectively mimics the biomechanics of a biological leg while matching the weight, size, and battery life of traditional prostheses, making it more practical for daily use.

Preclinical tests with three individuals showed that this prosthesis allows for natural walking movements and includes a passive mode for unlimited walking on level ground without needing to recharge, which is a significant advancement over existing powered prosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lightweight robotic leg prosthesis replicating the biomechanics of the knee, ankle, and toe joint. Tran, M., Gabert, L., Hood, S., et al.[2023]

In a study comparing prosthetic knee systems for U.S. military service members with transfemoral amputations, the Power Knee™ (PK) showed greater peak knee power in the amputated limb during sit-to-stand tasks compared to the C-Leg, suggesting enhanced performance for PK users.

Despite the differences in knee power, both prosthetic systems resulted in greater forces on the intact limb, indicating that while PK may improve certain tasks, it does not significantly reduce impact on the remaining joints compared to the C-Leg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Power Knee and C-Leg during step-up and sit-to-stand tasks. Wolf, EJ., Everding, VQ., Linberg, AA., et al.[2022]

Transfemoral amputees typically experience higher metabolic costs while walking due to the limitations of passive prostheses, which do not effectively mimic the biomechanics of natural legs.

This study indicates that using a lightweight powered prosthesis that generates knee power during late stance can potentially enhance walking ability and reduce the effort required for ambulation in transfemoral amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Analysis Of Positive Knee Energy Injection In A Transfemoral Amputee Walking With A Powered Prosthesis. Hood, SA., Lenzi, T.[2020]

Current lower limb prostheses lack the ability to replicate the energy distribution and function of natural musculature, which is crucial for effective movement.

The proposed above-knee prosthesis incorporates a self-energized mechanism that captures and stores energy from passive movements at the knee and ankle, enabling active plantar-flexion and improving locomotion efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active plantar-flexion above-knee prosthesis: concept and preliminary design. Rigas, C.[2017]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Functional added value of microprocessor-controlled knee joints in daily life performance of Medicare Functional Classification Level-2 amputees. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Powered knee and ankle prostheses enable natural ambulation on level ground and stairs for individuals with bilateral above-knee amputation: a case study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A lightweight robotic leg prosthesis replicating the biomechanics of the knee, ankle, and toe joint. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Does the impedance of above-knee powered prostheses need to be adjusted for load-carrying conditions? [2020]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of the Power Knee and C-Leg during step-up and sit-to-stand tasks. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of function, performance, and preference as transfemoral amputees transition from mechanical to microprocessor control of the prosthetic knee. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Increasing Assistance From a Powered Prosthesis on Weight-Bearing Symmetry, Effort, and Speed During Stand-Up in Individuals With Above-Knee Amputation. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Preliminary Analysis Of Positive Knee Energy Injection In A Transfemoral Amputee Walking With A Powered Prosthesis. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Early evaluation of a powered transfemoral prosthesis with force-modulated impedance control and energy regeneration. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Upslope walking with a powered knee and ankle prosthesis: initial results with an amputee subject. [2022]

11. France pubmed.ncbi.nlm.nih.gov

Active plantar-flexion above-knee prosthesis: concept and preliminary design. [2017]