A Powered Exoskeleton for Veterans With Knee OA

Design Improvements and Evaluation of a Knee Stress-Relief Powered Exoskeleton for Veterans With Knee Osteoarthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Keeogo

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Ding, PhD; Phone Number: (412) 688-6000; Email: dad5@pitt.edu
• Study Contact Backup: Name: Ann M Spungen, EdD; Phone Number: 5814 (718) 584-9000; Email: Ann.Spungen@va.gov

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10468-3904
      • Recruiting
      • James J. Peters VA Medical Center, Bronx, NY
      • Contact: Chung-Yung Tsai, PT PhD; Phone Number: 3130 (718) 584-9000; Email: chung-ying.tsai@va.gov
      • Contact: Ann M Spungen, EdD; Phone Number: 5814 718-584-9000; Email: Ann.Spungen@va.gov
      • Principal Investigator: Ann M Spungen, EdD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Knee OA group; Individuals who are over 18 years and have medical diagnosis of Grade 3 or 4 knee OA

Device: Keeogo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Numeric Pain Rating Scale results among different conditions	Rate pain on an 11-point numerical scale (0- no pain at all; 10- worst imaginable pain)	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	Reliable 10-item scale to evaluate device usability with a 5-point Likert scale from strongly disagree to strongly agree. Overall score from 0 to 100 with higher score indicating better usability.	Up to 5 minutes
Usefulness Satisfaction and Ease of Use Questionnaire	Reliable 30-item scale to evaluate four dimensions of usability including usefulness, ease of use, ease of learning, and satisfaction with a 7-point Likert scale. Average score from 0 to 7 for each dimension with higher score indicating better usability.	Up to 10 minutes

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: VA Pittsburgh Healthcare System
• Investigators: Principal Investigator: Ann M Spungen, EdD, James J. Peters Veterans Affairs Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: knee; walking; arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: A3228-R; RX-003228-01A2 (Other Identifier: VA R&D Merit Review)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No