Powered Exoskeleton for Knee Osteoarthritis

Not currently recruiting at 1 trial location

Overseen By Dan Ding, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological paralysis, Fixed contractures, Cardiovascular disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a robotic exoskeleton called Keeogo to determine if it helps individuals with severe knee osteoarthritis move better and feel less pain compared to regular knee braces. Researchers aim to improve walking, stair climbing, and other daily activities. Individuals may qualify if they have severe knee arthritis, use a prescribed knee brace, and experience movement difficulties due to knee pain. As an unphased trial, this study provides a unique opportunity to explore innovative technology that could enhance mobility and reduce pain.

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 Keeogo exoskeleton is safe for individuals with knee osteoarthritis?

Research has shown that the Keeogo exoskeleton is safe for people with knee osteoarthritis. In past studies, it helped users move and exercise without serious side effects. Reports indicate that most people tolerate the device well. Testing on individuals with knee issues revealed no major problems. This suggests that the Keeogo exoskeleton is a safe and promising option for improving mobility in people with knee osteoarthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for knee osteoarthritis, such as pain medications, physical therapy, or surgery, Keeogo is a powered exoskeleton that offers a novel approach. This device provides mechanical assistance to the knee, helping to reduce the load on the joint and potentially alleviating pain during movement. Researchers are excited about Keeogo because it not only supports mobility but also enhances the user's ability to perform daily activities without invasive procedures or long recovery times. This innovative approach could offer a new lifeline for those with severe knee OA who struggle with conventional treatments.

What evidence suggests that the Keeogo exoskeleton is effective for knee osteoarthritis?

Research has shown that the Keeogo exoskeleton, which participants in this trial will use, might help reduce pain and improve movement for people with knee osteoarthritis (OA). In early studies with six individuals who have knee OA, using the Keeogo reduced pain during activities like walking and standing. A larger study conducted at multiple locations also supported Keeogo's effectiveness as a mobility aid, suggesting it can help people move better in clinical settings. The exoskeleton is designed to support the knees during movement, potentially making activities like walking, climbing stairs, and daily tasks easier compared to regular knee braces. This suggests Keeogo could be a promising option for improving the quality of life for those with knee OA. ^{3 5 6 7 8}

Who Is on the Research Team?

Christopher Cardozo, MD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

This trial is for veterans with severe knee osteoarthritis (Grade 3 or 4) who experience pain and mobility limitations, have used a knee brace for at least three months, and struggle with activities like standing, walking, or climbing stairs. It's not suitable for those with neurological paralysis, normal walking speed, incompatible body measurements for the device, certain medical conditions (like cardiovascular issues), cognitive impairment as per MacCAT-T score <8/10, pregnancy/planning to become pregnant or joint contractures.

Inclusion Criteria

I have difficulty moving or walking because of knee pain and stiffness.

I have severe knee arthritis.

I experience knee pain during activities like standing or walking.

Exclusion Criteria

I can walk at a normal speed based on a test.

You are pregnant or trying to become pregnant.

I don't have health issues that prevent me from wearing a device or walking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-laboratory Evaluation

Participants undergo in-laboratory mobility tests using the Keeogo exoskeleton and standard knee braces

4-6 weeks

Multiple visits for testing

Follow-up

Participants are monitored for safety and effectiveness after the in-laboratory evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Keeogo

Trial Overview The study tests the Keeogo robotic exoskeleton designed to assist knees during movement against standard knee braces. The goal is to see if it improves mobility outcomes in lab tests such as walk test and stair test; reduces pain; and increases user satisfaction among people with impaired mobility due to knee osteoarthritis.

How Is the Trial Designed?

Group I: Knee OA group Experimental Treatment 1 Intervention

Individuals who are over 18 years and have medical diagnosis of Grade 3 or 4 knee OA

Keeogo is already approved in Canada for the following indications:

Approved in Canada as Keeogo for:

• Knee osteoarthritis
• Hip osteoarthritis
• Multiple sclerosis
• Parkinson’s disease

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Pittsburgh Healthcare System

Collaborator

Trials

36

Recruited

15,900+

Published Research Related to This Trial

The study developed a knee exoskeleton using a four-bar linkage design, which significantly reduced the peak actuating force by 45% and the overall mass of the device by 21% compared to existing models, enhancing its efficiency and usability.

This assistive device is designed to support individuals with injured knees by stabilizing ligaments, tendons, and muscles, and it can potentially be adapted for use in rehabilitation for those with monoplegia through control technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shape synthesis of an assistive knee exoskeleton device to support knee joint and rehabilitate gait. Singh, R., Chaudhary, H., Singh, AK.[2020]

Kinesio taping significantly reduced pain and improved walking tasks in patients with knee osteoarthritis compared to a placebo taping, with notable improvements observed after the third application and at the 1-month follow-up.

While Kinesio taping showed short-term benefits in pain relief and knee-flexion range of motion, there were no significant differences in overall muscle strength or range of motion between the Kinesio taping and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Kinesio Taping of the Knee Improve Pain and Functionality in Patients with Knee Osteoarthritis?: A Randomized Controlled Clinical Trial. Kaya Mutlu, E., Mustafaoglu, R., Birinci, T., et al.[2022]

Individuals with moderate mobility impairments (Berg Balance Scale scores of 46-51 and Timed Up and Go times of 8-12 seconds) are most likely to benefit from using the Keeogo™ dermoskeleton, as identified in a study of 13 participants with neurological impairments.

Wearing the Keeogo™ dermoskeleton significantly improved performance in various mobility tests, including the 30-second chair stand and stair climb tests, enhancing motor control, postural stability, and overall movement kinetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Keeogo™ Dermoskeleton. Mcleod, JC., Ward, SJ., Hicks, AL.[2020]

The Keeogo™ exoskeleton did not show immediate improvements in physical performance or activity levels in the short term for individuals with knee osteoarthritis, based on a study with 24 participants.

However, over time, users experienced significant cumulative benefits, including improved stair climbing times and reduced pain and stiffness, indicating that the device may enhance long-term mobility and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a lower-extremity robotic exoskeleton for people with knee osteoarthritis. McGibbon, C., Sexton, A., Jayaraman, A., et al.[2022]

The study involved 13 healthy adults and assessed how a lower-extremity robotic exoskeleton (dermoskeleton) affects knee biomechanics during walking, showing that it can reduce the knee adduction moment, which is beneficial for individuals with knee osteoarthritis (KOA).

While the dermoskeleton increased ground reaction forces and altered walking patterns (shorter and wider steps), it did not change gait speed, indicating that it may help maintain physical activity without compromising mobility in patients with KOA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an over-ground exoskeleton on external knee moments during stance phase of gait in healthy adults. McGibbon, CA., Brandon, SCE., Brookshaw, M., et al.[2018]

The newly designed micro silicone oil liquid spring in the power-assisted knee orthosis can generate a maximum assisted torque of 29.8 N·m, effectively aiding knee extension during movement.

Biomechanical analysis showed that the orthosis significantly reduces the load on the knee joint, decreasing forces at key joint sites by 24.5% to 21.2%, making it a promising option for users weighing around 80 kg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Design and biomechanical analysis of a self-force source power-assisted knee orthotics actuated by liquid spring]. Zhang, X., Feng, S., Chen, Z., et al.[2023]

In a study involving 187 patients with knee osteoarthritis, Kinesio Taping did not show superior effectiveness in improving mobility and function compared to non-specific knee taping, as both groups experienced similar outcomes in objective measures like gait speed and functional tests.

However, patients in the Kinesio Taping group reported higher satisfaction and perceived benefits regarding symptom relief and mobility improvement, suggesting that while the objective results were similar, the subjective experience of the treatment was more favorable for Kinesio Taping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of Kinesio Taping&#174; for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial. Donec, V., Kubilius, R.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10795663

Design Improvements and Evaluation of a Knee Stress-Relief ... Preliminary studies with the Keeogo™ in six persons with knee OA showed efficacy for pain reduction during different mobility tasks. However, a tuning guide ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33571072/

Evaluation of a lower-extremity robotic exoskeleton for ... A multi-site study was conducted to evaluate the efficacy of the Keeogo™ exoskeleton as a mobility assist device for use in the clinic and ...

3. keeogo.com keeogo.com/medias/logos/2.-McGibbon-et-al-2017Effects-over-ground-exoskeleton-external-knee-moments.pdf

Effects of an over-ground exoskeleton on external knee ... Several studies of the biomechanics of the OA knee observe a reduced 1st knee flexion moment in early stance [38–41] and in some studies an increased 2nd ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04653896

A Powered Exoskeleton for Veterans With Knee OA The purpose of this study is to evaluate in-laboratory mobility outcomes, pain perception, and user satisfaction with the Keeogo as compare with standard knee ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04653896/a-powered-exoskeleton-for-veterans-with-knee-oa

A Powered Exoskeleton for Veterans With Knee OA Preliminary studies with the Keeogo in six persons with knee OA showed efficacy for pain reduction during different mobility tasks. Keeogo ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6291941/

Evaluation of the Keeogo exoskeleton for assisting ... Keeogo is a lower-extremity powered exoskeleton that may be a potential solution for enabling people with MS to benefit from physical activity and exercise.

7. trials.arthritis.org trials.arthritis.org/trials/NCT04653896

A Powered Exoskeleton for Veterans With Knee OA An in-laboratory evaluation of performance outcomes using the Keeogo compared with standard knee braces are lacking. Absence of published prescription and ...

8. keeogo.com keeogo.com/medias/docs/Keeogo-Technical-Summary-TD-0350-EN.pdf

TECHNICAL SUMMARY Keeogo is a computer-controlled lower extremity motorized orthosis that has been used by individuals with medical conditions such as osteoarthritis of the knee ...