Clinical trial NCT04653896: A Powered Exoskeleton for Veterans With Knee OA
Official title: Design Improvements and Evaluation of a Knee Stress-Relief Powered Exoskeleton for Veterans With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee
arthritis
walking
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Pittsburgh Healthcare System
First posted: 2020-12-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will conduct a functional mobility comparison between Keeogo and knee braces among participants with knee OA. A within-subject design is selected. We plan to have 2 or 3 1-hour sessions per week (up to 12 sessions) for tuning the Keeogo and letting the participants be familiar with the device. After that, participants will be evaluated through a series of mobility tests using their prescribed knee braces and Keeogo configured with tuned parameters, respectively. If participants can complete the mobility tests without their knee braces we will also collect these data. The functional mobility tests will include the 6 Minute Walk Test, Timed Up and Go, 13-step Stair Test, Pick up Penny from Floor Test, and Short Physical Performance Battery. The investigators expect to use two separate sessions to finish the evaluations. The order of using the Keeogo and their knee braces will be randomized. There will be a 10-min break between each test. Participants could request a longer break time.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Knee osteoarthritis (OA) is a growing problem due to increased longevity and obesity with estimates of 14 million people living with this impairment. Knee OA results in decreased activity and lifestyle changes, further exacerbating an individual's health. Exoskeleton technology (Keeogo , B-temia, Inc.) may be a viable alternative to standard knee OA treatment by providing powered support to reduce pain during mobility. To the investigators' knowledge, the Keeogo is the only commercially available (in Canada) robotic exoskeleton for a non-paralyzed population who can stand and initiate a stepping action, but have impaired mobility for functional tasks. Keeogo provides active assistance during stance and swing phases and assists users to perform functional mobility tasks including walking, stair climbing, sit-to-stand, bending, squatting, and kneeling. Preliminary studies with the Keeogo in six persons with knee OA showed efficacy for pain reduction during different mobility tasks. Keeogo may have the potential to address functional mobility problems and pain in Veterans with knee OA but is not yet approved by the FDA. An in-laboratory evaluation of performance outcomes using the Keeogo compared with standard knee braces are lacking. Absence of published prescription and general guidelines for use in Veterans with knee OA were also identified as limitations.

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 braces. The investigators hypothesize that participants could have improved performance outcomes on mobility tests, including a 6-minute walk test, timed up and go test, 13-step 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 and reduced pain with the Keeogo by the numeric pain rating scale (NPRS) as compared with their prescribed knee braces for the mobility tests.

A knee OA-specific tuning protocol will be developed and used in the in-laboratory evaluations in 26 Veterans with knee OA at the James J. Peters VA Medical Center, Bronx, NY. This in-laboratory study is expected to demonstrate improved walking velocities, stair ascent/descent times, improved sit-to-stand, stand-to-sit, and object retrieval from the floor with reduced pain while participants use the Keeogo.

Eligibility 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

Primary outcomes:
measure: Changes of 6-Minute Walk Test results among different conditions
timeFrame: Up to 10 minutes for each condition: 1) using the Keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)
measure: Changes of Timed Up and Go Test results among different conditions
timeFrame: Up to 5 minutes for each condition: 1) using the Keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)
measure: Changes of 13-Step Stair Test results among different conditions
timeFrame: Up to 10 minutes for each condition: 1) using the Keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)
measure: Changes of Pick Up Penny from Floor Test results among different conditions
timeFrame: Up to 3 minutes for each condition: 1) Using the Keeogo; 2) Using the prescribed knee brace; 3) Using nothing on the knee (optional)
measure: Changes of Short Physical Performance Battery results among different conditions
timeFrame: 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)
Secondary outcomes:
measure: Changes of Numeric Pain Rating Scale results among different conditions
timeFrame: Up to 2 minutes for each condition: 1) using the Keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)
measure: System Usability Scale
timeFrame: Up to 5 minutes
measure: Usefulness Satisfaction and Ease of Use Questionnaire
timeFrame: Up to 10 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
Study officials:
affiliation: James J. Peters Veterans Affairs Medical Center
name: Christopher Cardozo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mcleod JC, Ward SJ, Hicks AL. Evaluation of the Keeogo Dermoskeleton. Disabil Rehabil Assist Technol. 2019 Jul;14(5):503-512. doi: 10.1080/17483107.2017.1396624. Epub 2017 Nov 2.
citation: McGibbon CA, Sexton A, Jayaraman A, Deems-Dluhy S, Gryfe P, Novak A, Dutta T, Fabara E, Adans-Dester C, Bonato P. Evaluation of the Keeogo exoskeleton for assisting ambulatory activities in people with multiple sclerosis: an open-label, randomized, cross-over trial. J Neuroeng Rehabil. 2018 Dec 12;15(1):117. doi: 10.1186/s12984-018-0468-6.