Powered Exoskeleton for Knee Osteoarthritis

N/A

Recruiting

Led By Ann M Spungen, EdD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

self-reported limitations to mobility and walking activities due to knee pain, stiffness, loss of range of motion

medical diagnosis of Grade 3 or 4 knee OA

Must not have

able to walk at a normal walking speed (>1.2 m/s) based on a 6-minute walk test (6MWT)

a score of <8/10 on the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) (as a proxy for cognitive competency screening)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 minutes for each condition: 1) using the keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a robotic exoskeleton can help people with impaired mobility walk better than with standard knee braces.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include discomfort from wearing the device, skin irritation where it contacts the body, muscle fatigue from new movement patterns or possible falls due to unfamiliarity with using an exoskeleton.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have severe knee arthritis.

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I have been using a prescribed knee brace for over three months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My cognitive ability to make treatment decisions is confirmed.

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I cannot stand or walk due to paralysis.

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I have stiff joints in my legs that limit my ability to move or sit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 minutes for each condition: 1) using the keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 minutes for each condition: 1) using the keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 minutes for each condition: 1) using the keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional) for reporting.