Powered Exoskeleton for Knee Osteoarthritis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Neurological paralysis, Fixed contractures, Cardiovascular disorders, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Keeogo for knee osteoarthritis?
Research shows that using the Keeogo exoskeleton over time can improve stair climbing ability and reduce pain and stiffness in people with knee osteoarthritis. Additionally, it has been shown to improve walking performance and daily activities in individuals with neurological impairments.
12345How does the Keeogo exoskeleton treatment differ from other treatments for knee osteoarthritis?
The Keeogo exoskeleton is unique because it is a wearable robotic device that assists with mobility, helping to improve physical function and reduce pain over time for people with knee osteoarthritis. Unlike traditional treatments that may involve medication or surgery, this device provides mechanical support to the knee, enhancing the user's ability to perform daily activities.
12567Eligibility Criteria
This trial is for veterans with severe knee osteoarthritis (Grade 3 or 4) who experience pain and mobility limitations, have used a knee brace for at least three months, and struggle with activities like standing, walking, or climbing stairs. It's not suitable for those with neurological paralysis, normal walking speed, incompatible body measurements for the device, certain medical conditions (like cardiovascular issues), cognitive impairment as per MacCAT-T score <8/10, pregnancy/planning to become pregnant or joint contractures.Inclusion Criteria
I have difficulty moving or walking because of knee pain and stiffness.
I have severe knee arthritis.
I experience knee pain during activities like standing or walking.
+1 more
Exclusion Criteria
I can walk at a normal speed based on a test.
You are pregnant or trying to become pregnant.
I don't have health issues that prevent me from wearing a device or walking.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
In-laboratory Evaluation
Participants undergo in-laboratory mobility tests using the Keeogo exoskeleton and standard knee braces
4-6 weeks
Multiple visits for testing
Follow-up
Participants are monitored for safety and effectiveness after the in-laboratory evaluation
4 weeks
Participant Groups
The study tests the Keeogo robotic exoskeleton designed to assist knees during movement against standard knee braces. The goal is to see if it improves mobility outcomes in lab tests such as walk test and stair test; reduces pain; and increases user satisfaction among people with impaired mobility due to knee osteoarthritis.
1Treatment groups
Experimental Treatment
Group I: Knee OA groupExperimental Treatment1 Intervention
Individuals who are over 18 years and have medical diagnosis of Grade 3 or 4 knee OA
Keeogo is already approved in Canada for the following indications:
🇨🇦 Approved in Canada as Keeogo for:
- Knee osteoarthritis
- Hip osteoarthritis
- Multiple sclerosis
- Parkinson’s disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
James J. Peters VA Medical Center, Bronx, NYBronx, NY
Loading ...
Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
VA Pittsburgh Healthcare SystemCollaborator
References
Evaluation of a lower-extremity robotic exoskeleton for people with knee osteoarthritis. [2022]A multi-site study was conducted to evaluate the efficacy of the Keeogo™ exoskeleton as a mobility assist device for use in the clinic and at home in people with knee osteoarthritis (KOA). Twenty-four participants were randomized in a two-stage cross-over design that evaluated the immediate effects of using the exoskeleton in the clinic and the cumulative effects of training and home use. Immediate effects were quantified by comparing 1) physical performance with|without (W|WO) the device during a battery of mobility tests, and 2) physical activity levels at home (actigraphy) for one month, two weeks W|WO the device. Cumulative effects were quantified as change in physical performance W and WO over time. WOMAC and other self-report scales were measured and usability assessed. There were no immediate effects on physical performance or physical activity at home; however, there were cumulative effects as indicated by improved stair time (p = .001) as well as improved WOMAC pain (p = .004) and function (p = .003). There was a direct relationship between improved physical function and improved WOMAC pain (r = -.677, p < .001) and stiffness (r = .537, p = .007). Weight and battery life were identified as important to usability. A full-scale RCT with more participants, longer study period, and better usage monitoring is warranted.
Effects of an over-ground exoskeleton on external knee moments during stance phase of gait in healthy adults. [2018]Physical activity and exercise is central to conservative management of knee osteoarthritis (KOA), but is often difficult for patients with KOA to maintain over the decade or more prior to surgical management. Better approaches are needed for maintaining physical function and health in this population that can also address the patho-biomechanics of the osteoarthritic knee. The objective of the study is to quantify how a lower-extremity robotic exoskeleton (dermoskeleton) modifies the external knee moments during over-ground walking in a sample of healthy adults, and to evaluate these biomechanical modifications in the context of the osteoarthritic knee.
Does Kinesio Taping of the Knee Improve Pain and Functionality in Patients with Knee Osteoarthritis?: A Randomized Controlled Clinical Trial. [2022]This study investigated the effect of Kinesio taping on the functionality, pain, range of motion (ROM), and muscle strength in patients with knee osteoarthritis compared with a placebo Kinesio tape (KT) application.
The effectiveness of Kinesio Taping® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate the effectiveness of the Kinesio Taping® method for mobility and functioning improvement for patients with knee osteoarthritis (KO).
Evaluation of the Keeogo™ Dermoskeleton. [2020]Purpose: (1) To determine the specific functional characteristics of individuals with neurological impairments that may predict successful use of Keeogo™ dermoskeleton and (2) to quantify the specific benefit Keeogo™ provides to a regular user of the device. Methods: Thirteen individuals (seven males; six females; 52 ± 4.6 years old) with mobility impairments due to neurological disease or injury were recruited. Berg Balance Sale (BBS) score and Timed Up and Go (TUG) performance were used to identify baseline characteristics in participants. The 6-min walk test (6MWT) and 25-foot walk test (25FWT) were performed with the participants wearing and not wearing the dermoskeleton; a successful user of Keeogo™ displayed a ≥ 5% improvement in walking performance while wearing the device. A chronic stroke survivor (hemiparesis on left side) completed the stair climb test (SCT) and the 30-second chair stand test (30CST) with and without Keeogo™. Muscle activity, kinetics and postural control were analyzed during the sit-to-stand (sitTS), and compared to an age- and sex-matched healthy control. Results: Successful users of Keeogo™ have a moderate level of functionality (BBS: 46-51 s and/or TUG: 8-12 s). Wearing Keeogo™ improved performance on the 30CST, SCT and improved motor control, postural control and movement kinetics during the sitTS task in a chronic stroke survivor with significant hemiparesis. Conclusion: This is the first study providing data to help to identify which individuals with neurological impairment might benefit from using Keeogo™ dermoskeleton, together with new information quantifying its functional benefit to the user. Implications for Rehabilitation Keeogo™ is a user-initiated dermoskeleton that has been designed to assist individuals with mobility impairments to participate more effectively in activities of daily living (ADLs). Moderately impaired individuals have the greatest potential to benefit from using the device. Benefits of wearing the device include improvements in walking speed and endurance, performance on ADLs, motor control, kinetics, and postural control.
[Design and biomechanical analysis of a self-force source power-assisted knee orthotics actuated by liquid spring]. [2023]A micro silicone oil liquid spring was designed and manufactured in this article. The performance of the liquid spring was studied by simulation analysis and mechanical test. A self-force source power-assisted knee orthosis was designed based on the liquid spring. This power-assisted knee orthosis can convert the kinetic energy of knee flexion into the elastic potential energy of liquid spring for storage, and release elastic potential energy to generate assisted torque which drives the knee joint for extension. The results showed that the average maximum reset force of the liquid spring was 1 240 N, and the average maximum assisted torque for the knee joint was 29.8 N·m. A musculoskeletal multibody dynamic model was used to analyze the biomechanical effect of the knee orthosis on the joint during knee bending (90°knee flexion). The results showed that the power-assisted knee orthosis could effectively reduce the biomechanical load of the knee joint for the user with a body weight of 80 kg. The maximum forces of the femoral-tibial joint force, patellar-femoral joint force, and quadriceps-ligament force were reduced by 24.5%, 23.8%, and 21.2%, respectively. The power-assisted knee orthosis designed in this article provides sufficient assisted torque for the knee joint. It lays a foundation for the subsequent commercial application due to its small size and lightweight.
Shape synthesis of an assistive knee exoskeleton device to support knee joint and rehabilitate gait. [2020]Purpose: The assistive knee exoskeleton device is used for supporting the surrounding ligaments, tendons, and muscles of the injured knee joint. Various knee exoskeletons have been discussed; however, their shape synthesis is not reported. This study aims to present the shape synthesis of the assistive knee device. Moreover, four-bar linkage is used for the knee exoskeleton, in this study. Methods: Clinical biomechanical data are adapted from gait database for one gait cycle. Using the clinical gait data, position and static force analyses are performed to obtain a set of orientations and unknown forces. Simultaneously, CAD models are prepared, and the obtained forces are applied to the CAD models of the four-bar linkage knee exoskeleton. Consequently, the threshold is obtained for each component of the knee exoskeleton and the unwanted material below the threshold is removed. Results: A reduction of 45% in the peak actuating force is observed in comparison with the literature. Besides, a total reduction of 21% in the mass of four-bar knee exoskeleton is observed in contrast to the base models when shape synthesis is performed. Conclusions: An assistive knee exoskeleton is developed using the shape synthesis methodology in which four-bar linkage is used. New shapes of thigh and shank attachments are obtained. The developed knee exoskeleton can be used by persons with the injured knee for supporting the ligaments, tendons, and muscles. Besides, control technology can be implemented to make it useful for persons with monoplegia. Implications for rehabilitation Assistive knee exoskeleton devices proved to be an important tool for providing support to injured knee joints. Typically single axis joints are observed in the lower limb exoskeletons which can be replaced with linkage mechanisms to obtain the desired range of motion. In this study, four-bar linkages are used for the knee exoskeleton in which cranks and rockers are connected to the lateral and medial sides of the knee joint, for connecting shank and thigh attachments. Shape synthesis is performed on the components of four-bar exoskeleton through the evaluated reaction forces. The components are assembled to form an assistive knee exoskeleton which can be used by any person with injured knee joint.