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A Powered Exoskeleton for Veterans With Knee OA

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ClinicalTrials.gov Identifier: NCT04653896
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : June 9, 2021
Sponsor:
Collaborator:
VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Keeogo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Design Improvements and Evaluation of a Knee Stress-Relief Powered Exoskeleton for Veterans With Knee Osteoarthritis
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.




Primary Outcome Measures :
  1. Changes of 6-Minute Walk Test results among different conditions [ Time Frame: 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) ]
    Walk as far as possible for 6 minutes. Distance in meters and speed in meter/second.

  2. Changes of Timed Up and Go Test results among different conditions [ Time Frame: 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) ]
    Time in seconds to stand up from a chair, walk 10 feet, turn, walk back to the chair, and sit down.

  3. Changes of 13-Step Stair Test results among different conditions [ Time Frame: 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) ]
    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.

  4. Changes of Pick Up Penny from Floor Test results among different conditions [ Time Frame: Up to 3 minutes for each condition: 1) Using the Keeogo; 2) Using the prescribed knee brace; 3) Using nothing on the knee (optional) ]
    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

  5. Changes of Short Physical Performance Battery results among different conditions [ Time Frame: 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) ]
    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.


Secondary Outcome Measures :
  1. Changes of Numeric Pain Rating Scale results among different conditions [ Time Frame: 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) ]
    Rate pain on an 11-point numerical scale (0- no pain at all; 10- worst imaginable pain)

  2. System Usability Scale [ Time Frame: Up to 5 minutes ]
    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.

  3. Usefulness Satisfaction and Ease of Use Questionnaire [ Time Frame: Up to 10 minutes ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653896


Contacts
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Contact: Ann M Spungen, EdD (718) 584-9000 ext 5814 Ann.Spungen@va.gov
Contact: Dan Ding, PhD (412) 688-6000 dad5@pitt.edu

Locations
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United States, New York
James J. Peters VA Medical Center, Bronx, NY Recruiting
Bronx, New York, United States, 10468
Contact: Ann M Spungen, EdD    718-584-9000 ext 5814    Ann.Spungen@va.gov   
Contact: Chung-Yung Tsai, PT PhD    (718) 584-9000 ext 3130    chung-ying.tsai@va.gov   
Principal Investigator: Ann M Spungen, EdD         
Sponsors and Collaborators
VA Office of Research and Development
VA Pittsburgh Healthcare System
Investigators
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Principal Investigator: Ann M Spungen, EdD James J. Peters Veterans Affairs Medical Center
Publications:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04653896    
Other Study ID Numbers: A3228-R
RX-003228-01A2 ( Other Identifier: VA R&D Merit Review )
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
knee
arthritis
walking
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases