Effect of using of a lower-extremity exoskeleton on disability of people with multiple sclerosis.

BACKGROUND: Although ongoing exercise is known to reduce disability in people with multiple sclerosis (MS), participation in lower-extremity exercise programs can be limited by their existing mobility impairments. Lower-extremity exoskeletons could address this problem by facilitating home and community locomotion and enhancing exercise capability but little data is available on the potential of this technology for reducing disability of people with MS. METHODS: We evaluated the Keeogo™ exoskeleton for people with MS using an open-label randomised cross-over design. The trial design allowed us to quantify rehabilitation effects (tested without device) and training effects (tested with device) using functional outcomes: 6-minute walk test (6MWT), timed stair test (TST), and timed up-and-go (TUG). Baseline and post-study self-report instruments included Medical Outcomes Survey Short Form-36 (SF36), MS Walking Scale (MSWS), and others. Amount of home use was documented by daily activity log. Partial correlation analysis was used to explore the relationships between changes in functional outcomes and self-report disability, controlling for amount of home use of the device. RESULTS: Twenty-nine participants with MS completed the trial. Change scores for MSWS, SF36 physical function and SF36 emotional well-being correlated positively with changes in 6MWT which was explained by amount of home use. CONCLUSIONS: The benefits in physical functioning and emotional well-being from using the exoskeleton at home were linked to amount of device usage. Low-profile robotic exoskeletons could be used to deliver facilitated exercise while assisting with locomotor activities of daily living, such as walking and stair climbing in the home and community environment.IMPLICATIONS FOR REHABILITATIONExoskeletons for home use may have the potential to benefit people with MS in terms of physical functioning and emotional well-being.The benefits in physical functioning and emotional well-being appeared to be linked to amount of usage.Exoskeletons might be useful for delivering facilitated exercise while assisting with walking and stair climbing in the home.

Evaluation of a lower-extremity robotic exoskeleton for people with knee osteoarthritis.

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.

Combining Accelerometer and GPS Features to Evaluate Community Mobility in Knee Ankle Foot Orthoses (KAFO) Users.

Orthotic and assistive devices such as knee ankle foot orthoses (KAFO), come in a variety of forms and fits, with several levels of available features that could help users perform daily activities more naturally. However, objective data on the actual use of these devices outside of the research lab is usually not obtained. Such data could enhance traditional lab-based outcome measures and inform clinical decision-making when prescribing new orthotic and assistive technology. Here, we link data from a GPS unit and an accelerometer mounted on the orthotic device to quantify its usage in the community and examine the correlations with clinical metrics. We collected data from 14 individuals over a period of 2 months as they used their personal KAFO first, and then a novel research KAFO; for each device we quantified number of steps, cadence, time spent at community locations and time wearing the KAFO at those locations. Sensor-derived metrics showed that mobility patterns differed widely between participants (mean steps: 591.3, SD =704.2). The novel KAFO generally enabled participants to walk faster during clinical tests ( ∆6 Minute-Walk-Test=71.5m, p=0.006). However, some participants wore the novel device less often despite improved performance on these clinical measures, leading to poor correlation between changes in clinical outcome measures and changes in community mobility ( ∆6 Minute-Walk-Test - ∆ Community Steps: r=0.09, p=0.76). Our results suggest that some traditional clinical outcome measures may not be associated with the actual wear time of an assistive device in the community, and obtaining personalized data from real-world use through wearable technology is valuable.

Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the potential of a microprocessor swing and stance controlled knee-ankle-foot orthosis (MPO) to improve balance, functional mobility, and quality of life in individuals with lower-extremity impairments as compared to a stance-control-orthosis (SCO) and conventional knee-ankle-foot orthosis (KAFO) over a use-period of a month. DESIGN: Randomized crossover study. SETTING: Ambulatory research laboratory and home and community for community-dwelling adults. PARTICIPANTS: Persons (N=18) who actively used a unilateral KAFO or SCO for impairments due to neurologic or neuromuscular disease, orthopedic disease, or trauma. INTERVENTION: Participants were trained to acclimate and use SCO and MPO. MAIN OUTCOME MEASURES: The 6-minute walk test (6MWT), 10-m walk test, Berg Balance Scale (BBS), functional gait assessment (FGA), hill assessment index, stair assessment index (SAI), Five Times Sit to Stand Test, crosswalk test, Modified Falls Efficacy Scale, Orthotic and Prosthetic User's Survey (OPUS), and World Health Organization Quality of Life (WHQOL)-BREF Scale. RESULTS: Significant changes were observed in participants' self-selected gait speed (P=.023), BBS (P=.01), FGA (P=.002), and SAI (P<.001) between baseline and post-MPO assessment. Similar significant differences were seen when comparing post-MPO with post-SCO data. During the 6MWT, persons using the MPO walked significantly longer (P=.013) than when using their baseline device. Participants reported higher quality of life scores in the OPUS (P=.02) and physical health domain of the WHOQOL-BREF (P=.037) after using the MPO. Participants reported fewer falls when wearing the MPO (5) versus an SCO (38) or locked KAFO (15). CONCLUSIONS: The MPO may contribute to improved quality of life and health status of persons with lower-extremity impairments by providing the ability to have better walking speed, endurance, and functional balance.

Evaluation of the Keeogo exoskeleton for assisting ambulatory activities in people with multiple sclerosis: an open-label, randomized, cross-over trial.

BACKGROUND: Although physical activity and exercise is known to benefit people with multiple sclerosis (MS), the ability of these individuals to participate in such interventions is difficult due to the mobility impairments caused by the disease. Keeogo is a lower-extremity powered exoskeleton that may be a potential solution for enabling people with MS to benefit from physical activity and exercise. METHODS: An open-label, randomized, cross-over trial was used to examine the immediate performance effects when using the device, and the potential benefits of using the device in a home setting for 2 weeks. Clinical performance tests with and without the device included the 6 min walk test, timed up and go test and the 10-step stair test (up and down). An activity monitor was also used to measure physical activity at home, and a patient-reported questionnaire was used to determine the amount and extent of home use. Generalized linear models were used to test for trial effects, and correlation analysis used to examine relationships between trial effects and usage. RESULTS: Twenty-nine patients with MS participated. All measures showed small decrements in performance while wearing the device compared to not wearing the device. However, significant improvements in unassisted (Rehab effect) performance were found after using the device at home for 2 weeks, compared to 2 weeks at home without the device, and participants improved their ability to use the device over the trial period (Training effect). Rehab and Training effects were related to the self-reported extent that participants used Keeogo at home. CONCLUSIONS: Keeogo appears to deliver an exercise-mediated benefit to individuals with MS that improved their unassisted gait endurance and stair climbing ability. Keeogo might be a useful tool for delivering physical activity interventions to individuals with mobility impairment due to MS. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02904382 . Registered 19 September 2016 - Retrospectively registered.

Impact of Powered Knee-Ankle Prosthesis on Low Back Muscle Mechanics in Transfemoral Amputees: A Case Series.

Regular use of prostheses is critical for individuals with lower limb amputations to achieve everyday mobility, maintain physical and physiological health, and achieve a better quality of life. Use of prostheses is influenced by numerous factors, with prosthetic design playing a critical role in facilitating mobility for an amputee. Thus, prostheses design can either promote biomechanically efficient or inefficient gait behavior. In addition to increased energy expenditure, inefficient gait behavior can expose prosthetic user to an increased risk of secondary musculoskeletal injuries and may eventually lead to rejection of the prosthesis. Consequently, researchers have utilized the technological advancements in various fields to improve prosthetic devices and customize them for user specific needs. One evolving technology is powered prosthetic components. Presently, an active area in lower limb prosthetic research is the design of novel controllers and components in order to enable the users of such powered devices to be able to reproduce gait biomechanics that are similar in behavior to a healthy limb. In this case series, we studied the impact of using a powered knee-ankle prostheses (PKA) on two transfemoral amputees who currently use advanced microprocessor controlled knee prostheses (MPK). We utilized outcomes pertaining to kinematics, kinetics, metabolics, and functional activities of daily living to compare the efficacy between the MPK and PKA devices. Our results suggests that the PKA allows the participants to walk with gait kinematics similar to normal gait patterns observed in a healthy limb. Additionally, it was observed that use of the PKA reduced the level of asymmetry in terms of mechanical loading and muscle activation, specifically in the low back spinae regions and lower extremity muscles. Further, the PKA allowed the participants to achieve a greater range of cadence than their predicate MPK, thus allowing them to safely ambulate in variable environments and dynamically control speed changes. Based on the results of this case series, it appears that there is considerable potential for powered prosthetic components to provide safe and efficient gait for individuals with above the knee amputation.

Activity Recognition in Individuals Walking With Assistive Devices: The Benefits of Device-Specific Models.

BACKGROUND: Wearable sensors gather data that machine-learning models can convert into an identification of physical activities, a clinically relevant outcome measure. However, when individuals with disabilities upgrade to a new walking assistive device, their gait patterns can change, which could affect the accuracy of activity recognition. OBJECTIVE: The objective of this study was to assess whether we need to train an activity recognition model with labeled data from activities performed with the new assistive device, rather than data from the original device or from healthy individuals. METHODS: Data were collected from 11 healthy controls as well as from 11 age-matched individuals with disabilities who used a standard stance control knee-ankle-foot orthosis (KAFO), and then a computer-controlled adaptive KAFO (Ottobock C-Brace). All subjects performed a structured set of functional activities while wearing an accelerometer on their waist, and random forest classifiers were used as activity classification models. We examined both global models, which are trained on other subjects (healthy or disabled individuals), and personal models, which are trained and tested on the same subject. RESULTS: Median accuracies of global and personal models trained with data from the new KAFO were significantly higher (61% and 76%, respectively) than those of models that use data from the original KAFO (55% and 66%, respectively) (Wilcoxon signed-rank test, P=.006 and P=.01). These models also massively outperformed a global model trained on healthy subjects, which only achieved a median accuracy of 53%. Device-specific models conferred a major advantage for activity recognition. CONCLUSIONS: Our results suggest that when patients use a new assistive device, labeled data from activities performed with the specific device are needed for maximal precision activity recognition. Personal device-specific models yield the highest accuracy in such scenarios, whereas models trained on healthy individuals perform poorly and should not be used in patient populations.

Evaluating the Functionality and Usability of Two Novel Wheelchair Anti-Rollback Devices for Ramp Ascent in Manual Wheelchair Users With Spinal Cord Injury.

BACKGROUND: Difficulty ascending ramps and inclines with a manual wheelchair adversely affects the everyday mobility and overall quality of life of manual wheelchair users. Currently, various anti-rollback devices are available to assist manual wheelchair users to ascend ramps and inclines. However, these devices have 2 main shortcomings: restriction to backward motion limiting recovery from an overturning wheelchair, which is a safety concern; and difficulty in engaging/disengaging the device while on the ramp. OBJECTIVE: To evaluate the functionality and usability of 2 novel wheelchair anti-rollback devices developed to address these shortcomings (prototypes "Wheel" and "Brake"). DESIGN: Cross-sectional. SETTING: Rehabilitation research facility. PARTICIPANTS: Twelve adult participants with chronic spinal cord injury. METHODS: Participants completed training and tested with both the wheelchair anti-rollback devices on a 7.3-m-long ramp. MAIN OUTCOME MEASUREMENTS: Number of stops, perceived physical exertion, pain, and ease of use of these devices as participants maneuvered their wheelchairs up a 7.3-m ramp were assessed. Participants also evaluated their satisfaction with the usability of both the devices using the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST 2.0). RESULTS: Both prototypes evaluated overcame the limitations of the existing anti-rollback devices. Nonparametric statistical tests showed that participants rated both prototypes similarly for the overall functional and usability aspects. However, the participants' satisfactory rating were higher for the prototype "Brake" than for the prototype "Wheel" based on a functional aspect (ie, engaging/disengaging easiness), and higher for Wheel than for Brake, based on a usability aspect (prototype size). CONCLUSIONS: The qualitative and quantitative outcomes of this investigation, based on the usability and functional evaluations, provided useful information for the improvement in the design of both anti-rollback devices, which may allow manual wheelchair users to manage ramp ascent more safely and easily. Further evaluations with a different SCI population is recommended. LEVEL OF EVIDENCE: IV.