A Powered Exoskeleton for Veterans With Knee OA

NCT04653896 | Active Not Recruiting FDA Device

• 2 other identifiers: A3228-RRX-003228-01A2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee; arthritis; walking

Outcome Measures

Primary Outcomes (5)

• Changes of 6-Minute Walk Test results among different conditions

  Walk as far as possible for 6 minutes. Distance in meters and speed in meter/second.

  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)

• Changes of Timed Up and Go Test results among different conditions

  Time in seconds to stand up from a chair, walk 10 feet, turn, walk back to the chair, and sit down.

  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)

• Changes of 13-Step Stair Test results among different conditions

  Ascend and descend a 13-step stair as quickly as possible but safely. Time in seconds till both feet on the top as ascent time. Time in seconds till both feet on the bottom as descent time.

  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)

• Changes of Pick Up Penny from Floor Test results among different conditions

  Time in seconds to bend, scoop, lunge, or squat to retrieve a penny from the floor and return to standing. Scored as: not able to perform, perform with physical assistance, perform unassisted

  Up to 3 minutes for each condition: 1) Using the Keeogo; 2) Using the prescribed knee brace; 3) Using nothing on the knee (optional)

• Changes of Short Physical Performance Battery results among different conditions

  Three tests to assess lower extremity functioning: ability to stand for 10 seconds with feet in 3 different positions (together side-by-side, semi-tandem, and tandem), two timed 4-meter walk, and time to rise from a chair five times. Overall score from 0 to 12 with higher score indicating better lower extremity function.

  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 (3)

• Changes of Numeric Pain Rating Scale results among different conditions

  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)

• System Usability Scale

  Up to 5 minutes

• Usefulness Satisfaction and Ease of Use Questionnaire

  Up to 10 minutes

Study Arms (1)

Knee OA group

EXPERIMENTAL

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

Device: Keeogo

Interventions

Keeogo DEVICE

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.

Knee OA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Pittsburgh Healthcare System: collaborator

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

Related Publications (2)

• 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.

  PMID: 29092649 BACKGROUND

• 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.

  PMID: 30541585 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Christopher Cardozo, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 4, 2020
• Study Start: June 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)