Powered Exoskeleton for Knee Osteoarthritis

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

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate in-laboratory mobility outcomes, pain perception, and user satisfaction with the Keeogo , a robotic exoskeleton for providing assistance on knees during stand and swing for a population with impaired mobility, as compare with standard knee braces. The investigators hypothesize that participants could have improved performance outcomes on walk test, timed up and go test, stair test, pick up penny from floor test, and the Short Physical Performance Battery (SPPB) when using the Keeogo as compared with their prescribed knee braces.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the Keeogo exoskeleton treatment differ from other treatments for knee osteoarthritis?

The Keeogo exoskeleton is unique because it is a wearable robotic device that assists with mobility, helping to improve physical function and reduce pain over time for people with knee osteoarthritis. Unlike traditional treatments that may involve medication or surgery, this device provides mechanical support to the knee, enhancing the user's ability to perform daily activities. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Keeogo for knee osteoarthritis?

Research shows that using the Keeogo exoskeleton over time can improve stair climbing ability and reduce pain and stiffness in people with knee osteoarthritis. Additionally, it has been shown to improve walking performance and daily activities in individuals with neurological impairments. ^{1 2 3 6 7}

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 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]

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]

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]

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 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]

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]

Citations

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

Evaluation of a lower-extremity robotic exoskeleton for people with knee osteoarthritis. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of an over-ground exoskeleton on external knee moments during stance phase of gait in healthy adults. [2018]

3. United States 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. [2022]

4. England 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. [2022]

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

Evaluation of the Keeogo™ Dermoskeleton. [2020]

6. China pubmed.ncbi.nlm.nih.gov

[Design and biomechanical analysis of a self-force source power-assisted knee orthotics actuated by liquid spring]. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Shape synthesis of an assistive knee exoskeleton device to support knee joint and rehabilitate gait. [2020]