Robotic exoskeleton for veterans with knee osteoarthritis
Design Improvements and Evaluation of a Knee Stress-Relief Powered Exoskeleton for Veterans With Knee Osteoarthritis
This study is testing if a robotic exoskeleton can help veterans with knee osteoarthritis walk better and feel less pain compared to regular knee braces.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Bronx, New York) |
| Trial ID | NCT04653896 on ClinicalTrials.gov |
What this trial studies
This study evaluates the mobility outcomes, pain perception, and user satisfaction of the Keeogo robotic exoskeleton in veterans suffering from knee osteoarthritis compared to standard knee braces. The Keeogo provides powered assistance during mobility tasks such as walking and stair climbing, aiming to improve functional performance and reduce pain. Participants will undergo various mobility tests to assess the effectiveness of the exoskeleton in enhancing their daily activities. The study seeks to fill the gap in existing research regarding the use of exoskeletons for non-paralyzed individuals with impaired mobility.
Who should consider this trial
Good fit: Ideal candidates are veterans diagnosed with Grade 3 or 4 knee osteoarthritis who have been using a knee brace for at least three months.
Not a fit: Patients with neurological paralysis or those who can walk at a normal speed may not benefit from this study.
Why it matters
Potential benefit: If successful, this could significantly improve mobility and quality of life for veterans with knee osteoarthritis.
How similar studies have performed: Preliminary studies have shown efficacy for pain reduction with the Keeogo in individuals with knee osteoarthritis, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * medical diagnosis of Grade 3 or 4 knee OA * have a prescribed knee brace for at least three months * self-reported knee pain when standing, walking, climbing stairs, squatting, or other mobility activities * self-reported limitations to mobility and walking activities due to knee pain, stiffness, loss of range of motion Exclusion Criteria: * neurological paralysis causing an inability to stand, weight bear or take stepping movements * fixed contractures resulting in limited range of motion in the hip, knees, or ankles that prevent sitting, standing, walking, and/or squatting activities * able to walk at a normal walking speed (\>1.2 m/s) based on a 6-minute walk test (6MWT) * anthropometric incompatibility with the device * any medical complication or co-morbidity as judged by the study physician to be contraindicated for wearing the device or walking (e.g., cardiovascular disorders, pressure ulcers, open wounds, lower limb vascular disorders, or other medical conditions) * a score of \<8/10 on the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) (as a proxy for cognitive competency screening); and 7) pregnancy or planning on becoming pregnant
Where this trial is running
Bronx, New York
- James J. Peters VA Medical Center, Bronx, NY — Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Cardozo, MD — James J. Peters Veterans Affairs Medical Center
- Study coordinator: Ann M Spungen, EdD
- Email: Ann.Spungen@va.gov
- Phone: (718) 584-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.