Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04653896
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2020-11-12
Brief Title:
A Powered Exoskeleton for Veterans With Knee OA
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Design Improvements and Evaluation of a Knee Stress-Relief Powered Exoskeleton for Veterans With Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 individuals 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 ascentdescent times improved sit-to-stand stand-to-sit and object retrieval from the floor with reduced pain while participants use the Keeogo
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 ascentdescent times improved sit-to-stand stand-to-sit and object retrieval from the floor with reduced pain while participants use the Keeogo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RX-003228-01A2 | OTHER | VA RD Merit Review | None |