65 Participants NeededMy employer runs this trial

Modular Powered Orthoses for Knee Arthritis

EK
RG
KP
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Overseen ByRobert Gregg, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wearable device, known as a modular powered orthosis (exoskeleton), to assist individuals with knee osteoarthritis. The goal is to determine if this device can ease knee pain and reduce muscle effort during daily activities by taking on some of the work usually done by muscles. It targets individuals medically diagnosed with knee osteoarthritis who experience significant pain during daily activities. Participants should be able to walk for six minutes without assistance from another person and manage stairs or ramps, even if using a walking aid. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for managing knee osteoarthritis pain.

What prior data suggests that this device is safe for managing knee arthritis?

Research has shown that powered exoskeletons are generally safe for people with knee arthritis. Studies have found that these devices can reduce stress on the knee and improve movement without surgery, making them well-received by users. For instance, the Ascend exoskeleton is lightweight and provides crucial knee support for those with osteoarthritis.

Regarding safety, several exoskeletons, such as the ReWalk and Indego, have received FDA approval for other uses. Although these are different devices, their approval suggests that similar technologies can be safely used in people. Overall, while more research is beneficial, current evidence indicates that powered exoskeletons are a safe option for managing knee arthritis pain.12345

Why are researchers excited about this trial?

Unlike traditional treatments for knee arthritis, which mainly include pain medications, physical therapy, and sometimes surgery, the modular powered orthosis offers a unique approach. This wearable exoskeleton not only supports the knee but also assists with movement, potentially reducing pain and improving mobility. Researchers are excited because it could provide immediate support and relief without the need for drugs or invasive procedures, offering a new, non-invasive way to manage knee arthritis.

What evidence suggests that this modular powered orthosis is effective for knee osteoarthritis?

This trial will evaluate the effectiveness of modular powered orthoses, such as exoskeletons, in reducing knee strain. Studies have shown that these devices can significantly reduce strain on knee muscles. For instance, one study found that wearing an exoskeleton lowered muscle activity by 44.8–71.5%. Another study demonstrated that participants walked 24.11% faster and took steps 7.41% longer, indicating improved movement. These exoskeletons support the knee by sharing some of the joint's workload, which can alleviate pain for individuals with osteoarthritis. By easing the strain on muscles during everyday activities, they can effectively manage knee pain. Participants in this trial will perform various tasks while wearing the modular powered orthosis to assess these benefits.678910

Are You a Good Fit for This Trial?

This trial is for people with knee osteoarthritis or arthritis who have pain and difficulty moving their knees. Participants should be able to walk and perform daily activities, but may struggle due to joint pain or weakness.

Inclusion Criteria

Knee osteoarthritis participants weigh less than 300 lbs due to challenges in bracing heavier participants
Able-bodied, young participants BMI less than 40 due to challenges in bracing heavier participants
I can walk for 6 minutes without help from another person.
See 7 more

Exclusion Criteria

I do not have major memory or vision problems that affect my understanding or ability to follow instructions.
I have a nerve or heart problem that makes it hard for me to walk.
I have knee osteoarthritis with uncontrolled high blood pressure or diabetes.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform various tasks while wearing the modular powered orthosis to assess muscle effort, joint moment load, and pain score

8 weeks
Multiple visits for assessments and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Modular powered orthosis

Trial Overview

The study tests a new motorized knee brace (powered orthosis) that helps support the knee during movement. The device aims to reduce pain and muscle effort by assisting with some of the force needed for walking and other daily tasks.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ExoskeletonExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials
102
Recruited
21,600+

Citations

(PDF) Is modular control related to functional outcomes in ...

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Under the condition of wearing the exoskeleton, the average reduction of muscle activity was 44.8–71.5%, and the plantar pressure was 58.5–64.2%.

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Patients who utilized valgus knee braces experienced significantly decreased levels of pain 2,3,6 and improved levels of function. 2, 6 cannot reduce

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The developed prototype achieved up to 40% weight reduction compared with a conventional hinged metal orthosis, while reducing peak limb- ...

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The results show that the simulation model design is reasonable and the effectiveness of the improvement of the hydraulic cylinder is verified.

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Results of the joint flexion data are provided in Table 3-2. These values represent the maximum averages across the six trials of hip and knee flexion of the ...

Exoskeleton Device Helps People with Arthritic Knees

exoskeleton prototype aimed at helping those who struggle to walk because of osteoarthritis in their knees. exoskeletons, which are wearable ...

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The results suggest that the use of exoskeletons or orthoses customized to the users' needs will continue to increase over the years due to the ...

The Effect of Powered-Knee Exoskeleton... | Clinical Trial

The purpose of this research study is to determine if using an exoskeleton during stair climbing training will result in an improved ability to walk and climb ...