A Powered Exoskeleton for Veterans With Knee OA
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Keeogo
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, arthritis, walking
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
Sites / Locations
- James J. Peters VA Medical Center, Bronx, NYRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Knee OA group
Arm Description
Individuals who are over 18 years and have medical diagnosis of Grade 3 or 4 knee OA
Outcomes
Primary Outcome Measures
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.
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.
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.
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
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.
Secondary Outcome Measures
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)
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.
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.
Full Information
NCT ID
NCT04653896
First Posted
November 12, 2020
Last Updated
March 21, 2023
Sponsor
VA Office of Research and Development
Collaborators
VA Pittsburgh Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT04653896
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Pittsburgh Healthcare System
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee, arthritis, walking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Knee OA group
Arm Type
Experimental
Arm Description
Individuals who are over 18 years and have medical diagnosis of Grade 3 or 4 knee OA
Intervention Type
Device
Intervention Name(s)
Keeogo
Intervention Description
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 Measure Information:
Title
Changes of 6-Minute Walk Test results among different conditions
Description
Walk as far as possible for 6 minutes. Distance in meters and speed in meter/second.
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)
Title
Changes of Timed Up and Go Test results among different conditions
Description
Time in seconds to stand up from a chair, walk 10 feet, turn, walk back to the chair, and sit down.
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)
Title
Changes of 13-Step Stair Test results among different conditions
Description
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.
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)
Title
Changes of Pick Up Penny from Floor Test results among different conditions
Description
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
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)
Title
Changes of Short Physical Performance Battery results among different conditions
Description
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.
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)
Secondary Outcome Measure Information:
Title
Changes of Numeric Pain Rating Scale results among different conditions
Description
Rate pain on an 11-point numerical scale (0- no pain at all; 10- worst imaginable pain)
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)
Title
System Usability Scale
Description
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.
Time Frame
Up to 5 minutes
Title
Usefulness Satisfaction and Ease of Use Questionnaire
Description
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.
Time Frame
Up to 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann M Spungen, EdD
Phone
(718) 584-9000
Ext
5814
Email
Ann.Spungen@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Ding, PhD
Phone
(412) 688-6000
Email
dad5@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M Spungen, EdD
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468-3904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann M Spungen, EdD
Phone
718-584-9000
Ext
5814
Email
Ann.Spungen@va.gov
First Name & Middle Initial & Last Name & Degree
Chung-Yung Tsai, PT PhD
Phone
(718) 584-9000
Ext
3130
Email
chung-ying.tsai@va.gov
First Name & Middle Initial & Last Name & Degree
Ann M Spungen, EdD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29092649
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.
Results Reference
background
PubMed Identifier
30541585
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.
Results Reference
background
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A Powered Exoskeleton for Veterans With Knee OA
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