ACTIVE_NOT_RECRUITING

A Powered Exoskeleton for Veterans With Knee OA

Conditions

Knee Osteoarthritis knee arthritis walking

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-01

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04653896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Christopher Cardozo, MD

PRINCIPAL_INVESTIGATOR

James J. Peters Veterans Affairs Medical Center

Study Locations (Sites)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Christopher Cardozo, MD, PRINCIPAL_INVESTIGATOR, James J. Peters Veterans Affairs Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-06-01

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

knee
arthritis
walking

Additional Relevant MeSH Terms

Knee Osteoarthritis