Outcomes of a Multicenter Safety and Efficacy Study of the SuitX Phoenix Powered Exoskeleton for Ambulation by Patients With Spinal Cord Injury.
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SUBMITTER: Koljonen PA
PROVIDER: S-EPMC8326794 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Objective: To assess safety and mobility outcomes utilizing the Indego powered exoskeleton in indoor and outdoor walking conditions with individuals previously diagnosed with a spinal cord injury (SCI). Methods: We conducted a multicenter prospective observational cohort study in outpatient clinics associated with 5 rehabilitation hospitals. A convenience sample of nonambulatory individuals with SCI (N = 32) completed an 8-week training protocol consisting of walking training 3 times per week utilizing the Indego powered exoskeleton in indoor and outdoor conditions. Participants were also trained in donning/doffing the exoskeleton during each session. Safety measures such as adverse events (AEs) were monitored and reported. Time and independence with donning/doffing the exoskeleton as well as walking outcomes to include the 10-meter walk test (10MWT), 6-minute walk test (6MWT), Timed Up & Go test (TUG), and 600-meter walk test were evaluated from midpoint to final evaluations. Results: All 32 participants completed the training protocol with limited device-related AEs, which resulted in no interruption in training. The majority of participants in this trial were able to don and doff the Indego independently. Final walking speed ranged from 0.19 to 0.55 m/s. Final average indoor and outdoor walking speeds among all participants were 0.37 m/s (SD = 0.08, 0.09, respectively), after 8 weeks of training. Significant (p < .05) improvements were noted between midpoint and final gait speeds in both indoor and outdoor conditions. Average walking endurance also improved among participants after training. Conclusion: The Indego was shown to be safe for providing upright mobility to 32 individuals with SCIs who were nonambulatory. Improvements in speed and independence were noted with walking in indoor and outdoor conditions as well as with donning/doffing the exoskeleton.
| S-EPMC5791927 | biostudies-literature
Project description:Powered exoskeletons have become available for overground ambulation in persons with paralyses due to spinal cord injury (SCI) who have intact upper extremity function and are able to maintain upright balance using forearm crutches. To ambulate in an exoskeleton, the user must acquire the ability to maintain balance while standing, sitting and appropriate weight shifting with each step. This can be a challenging task for those with deficits in sensation and proprioception in their lower extremities. This manuscript describes screening criteria and a training program developed at the James J. Peters VA Medical Center, Bronx, NY to teach users the skills needed to utilize these devices in institutional, home or community environments. Before training can begin, potential users are screened for appropriate range of motion of the hip, knee and ankle joints. Persons with SCI are at an increased risk of sustaining lower extremity fractures, even with minimal strain or trauma, therefore a bone mineral density assessment is performed to reduce the risk of fracture. Also, as part of screening, a physical examination is performed in order to identify additional health-related contraindications. Once the person has successfully passed all screening requirements, they are cleared to begin the training program. The device is properly adjusted to fit the user. A series of static and dynamic balance tasks are taught and performed by the user before learning to walk. The person is taught to ambulate in various environments ranging from indoor level surfaces to outdoors over uneven or changing surfaces. Once skilled enough to be a candidate for home use with the exoskeleton, the user is then required to designate a companion-walker who will train alongside them. Together, the pair must demonstrate the ability to perform various advanced tasks in order to be permitted to use the exoskeleton in their home/community environment.
| S-EPMC4927801 | biostudies-literature
Project description:BackgroundPowered exoskeletons for over ground walking were designed to help people with neurological impairments to walk again. Extended training in powered exoskeletons has led to changes in walking and physiological functions. Few studies have considered the perspective of the participants. The users' perspective is vital for adoption of assistive devices. We explored the expectations and experiences of persons with spinal cord injury, training with the ReWalk exoskeleton.MethodsA qualitative research design with individual interviews was used. Eleven participants with spinal cord injury, taking part in 12 weeks of 4 times weekly training using the ReWalk, were interviewed before, immediately after, and 2 months after training. Interviews were audio recorded and transcribed verbatim. A six stage approach to thematic analysis was used.ResultsThe theme consistently expressed was the exoskeleton allowed participants to do everyday activities, like everyone else, such as looking people in the eye or walking outside. Their experiences were captured in three categories: 1) learning, a description of both expectations for learning and perspectives on how learning occurred; 2) changing, perspectives on perceived changes with training; and 3) contributing, which captured participant perspectives on contributing to research, including the giving of direct feedback regarding the exoskeleton (i.e., what worked and what could be changed).ConclusionsIncorporating the view of the user in the design and refinement of exoskeletons will help ensure that the devices are appropriate for future users. Availability and support for the use of exoskeleton devices in community settings is an interim step to home use as the devices continue to improve.Trial registrationwww.clinicaltrials.gov ( NCT02322125 ). Registered Dec 22, 2014 - Retrospectively registered after the first 4 participants had enrolled in the study.
| S-EPMC6642539 | biostudies-literature
Project description:BACKGROUND:Powered exoskeleton can improve the mobility for people with movement deficits by providing mechanical support and facilitate the gait training. This pilot study evaluated the effect of gait training using a newly developed powered lower limb exoskeleton robot for individuals with complete spinal cord injury (SCI). METHODS:Two participants with a complete SCI were recruited for this clinical study. The powered exoskeleton gait training was 8 weeks, 1 h per session, and 2 sessions per week. The evaluation was performed before and after the training for (1) the time taken by the user to don and doff the powered exoskeleton independently, (2) the level of exertion perceived by participants while using the powered exoskeleton, and (3) the mobility performance included the timed up-and-go test, 10-m walk test, and 6-min walk test with the powered exoskeleton. The safety of the powered exoskeleton was evaluated on the basis of injury reports and the incidence of falls or imbalance while using the device. RESULTS:The results indicated that the participants were donning and doffing the powered lower limb exoskeleton robot independently with a lower level of exertion and walked faster and farther without any injury or fall incidence when using the powered exoskeleton than when using a knee-ankle-foot orthosis. Bone mineral densities was also increased after the gait training. No adverse effects, such as skin abrasions, or discomfort were reported while using the powered exoskeleton. CONCLUSIONS:The findings demonstrated that individuals with complete SCI used the powered lower limb exoskeleton robot independently without any assistance after 8 weeks of powered exoskeleton gait training. TRIAL REGISTRATION:Trial registration: National Taiwan University Hospital. TRIAL REGISTRATION NUMBER:201210051RIB . Name of registry: Hui-Fen Mao. URL of registry: Not available. Date of registration: December 12th, 2012. Date of enrolment of the first participant to the trial: January 3rd, 2013.
| S-EPMC5838988 | biostudies-literature
Project description:In addition to helping individuals with spinal cord injury (SCI) regain the ability to ambulate, the rapidly evolving capabilities of robotic exoskeletons provide an array of secondary biophysical benefits which can reduce the complications resulting from prolonged immobilization. The proposed benefits of increased life-long over-ground walking capacity include improved upper body muscular fitness, improved circulatory response, improved bowel movement regularity, and reduced pain and spasticity. Beyond the positive changes related to physical and biological function, exoskeletons have been suggested to improve SCI individuals' quality of life (QOL) by allowing increased participation in day-to-day activities. Most of the currently available studies that have reported on the impact of exoskeletons on the QOL and prevention of secondary health complications on individuals with SCI, are of small scale and are heterogeneous in nature. Moreover, few meta-analyses and reviews have attempted to consolidate the dispersed data to reach more definitive conclusions of the effects of exoskeleton use. This scoping review seeks to provide an overview on the known effects of overground exoskeleton use, on the prevention of secondary health complications, changes to the QOL, and their effect on the independence of SCI individuals in the community settings. Moreover, the intent of the review is to identify gaps in the literature currently available, and to make recommendations on focus study areas and methods for future investigations.
| S-EPMC8960715 | biostudies-literature
Project description:Individuals with spinal cord injury (SCI) often use a wheelchair for mobility due to paralysis. Powered exoskeletal-assisted walking (EAW) provides a modality for walking overground with crutches. Little is known about the EAW velocities and level of assistance (LOA) needed for these devices.The primary aim was to evaluate EAW velocity, number of sessions, and LOA and the relationships among them. The secondary aims were to report on safety and the qualitative analysis of gait and posture during EAW in a hospital setting.Twelve individuals with SCI ? 1.5 years who were wheelchair users participated. They wore a powered exoskeleton (ReWalk; ReWalk Robotics, Inc., Marlborough, MA) with Lofstrand crutches to complete 10-meter (10 MWT) and 6-minute (6MWT) walk tests. LOA was defined as modified independence (MI), supervision (S), minimal assistance (Min), and moderate assistance (Mod). Best effort EAW velocity, LOA, and observational gait analysis were recorded.Seven of 12 participants ambulated ? 0.40 m/s. Five participants walked with MI, 3 with S, 3 with Min, and 1 with Mod. Significant inverse relationships were noted between LOA and EAW velocity for both 6 MWT (Z value = 2.63, Rho = 0.79, P = .0086) and 10 MWT (Z value = 2.62, Rho = 0.79, P = .0088). There were 13 episodes of mild skin abrasions. MI and S groups ambulated with 2-point alternating crutch pattern, whereas the Min and Mod groups favored 3-point crutch gait.Seven of 12 individuals studied were able to ambulate at EAW velocities ? 0.40 m/s, which is a velocity that may be conducive to outdoor activity-related community ambulation. The ReWalk is a safe device for in-hospital ambulation.
| S-EPMC4568091 | biostudies-literature
Project description:BackgroundThe Spinal Cord Injury Functional Ambulation Profile (SCI-FAP) is a valid, reliable measure of walking skill (eg, walking while negotiating obstacles, doors, and stairs).ObjectiveThe responsiveness of the SCI-FAP was assessed at least 7 months after spinal cord injury (SCI) and compared with that of the 10-Meter Walk Test (10MWT) and the Six-Minute Walk Test (6MWT).DesignA secondary analysis of data collected during a randomized, single-blind, crossover trial was performed.MethodsParticipants had incomplete SCI and could walk at least 5 m without manual assistance. After 3 or 4 baseline assessments, participants completed 2 months of precision training (stepping over obstacles and onto targets on the ground) and 2 months of endurance training (treadmill training with body weight support, if needed). Walking function was assessed with the SCI-FAP, 10MWT, and 6MWT. Internal responsiveness was evaluated through change scores and standardized response means (SRMs). External responsiveness was gauged by correlating change scores on the SCI-FAP, 10MWT, and 6MWT. The minimal detectable change was calculated from the standard error of measurement from the baseline assessments.ResultsThe SCI-FAP scores improved with both interventions. The magnitude of change was greater for participants whose pretraining self-selected speed was less than 0.5 m/s. The SCI-FAP had moderate SRMs. The 10MWT (fastest speed) and 6MWT had the largest SRMs after precision training and endurance training, respectively. The minimal detectable change in the SCI-FAP was 96 points.LimitationsThe convenience sample was small and all participants could ambulate independently (with devices); therefore, the generalizability of the findings is limited.ConclusionsThe SCI-FAP was responsive to changes in walking ability in participants who had incomplete SCI and walked at slow speeds, but overall the 10MWT and 6MWT were more responsive.
| S-EPMC3912625 | biostudies-literature
Project description:Recovering the ability to stand and walk independently can have numerous health benefits for people with spinal cord injury (SCI). Wearable exoskeletons are being considered as a promising alternative to conventional knee-ankle-foot orthoses (KAFOs) for gait training and assisting functional mobility. However, comparisons between these two types of devices in terms of gait biomechanics and energetics have been limited. Through a randomized, crossover clinical trial, this study compared the use of a knee-powered lower limb exoskeleton (the ABLE Exoskeleton) against passive orthoses, which are the current standard of care for verticalization and gait ambulation outside the clinical setting in people with SCI. Ten patients with SCI completed a 10-session gait training program with each device followed by user satisfaction questionnaires. Walking with the ABLE Exoskeleton improved gait kinematics compared to the KAFOs, providing a more physiological gait pattern with less compensatory movements (38% reduction of circumduction, 25% increase of step length, 29% improvement in weight shifting). However, participants did not exhibit significantly better results in walking performance for the standard clinical tests (Timed Up and Go, 10-m Walk Test, and 6-min Walk Test), nor significant reductions in energy consumption. These results suggest that providing powered assistance only on the knee joints is not enough to significantly reduce the energy consumption required by people with SCI to walk compared to passive orthoses. Active assistance on the hip or ankle joints seems necessary to achieve this outcome.
| S-EPMC9646697 | biostudies-literature
Project description:BACKGROUND:Powered exoskeletons provide a way to stand and walk for people with severe spinal cord injury. Here, we used the ReWalk exoskeleton to determine the training dosage required for walking proficiency, the sensory and motor changes in the nervous system with training, and the functionality of the device in a home-like environment. METHODS:Participants with chronic (> 1 yr) motor complete or incomplete spinal cord injury, who were primarily wheelchair users, were trained to walk in the ReWalk for 12 weeks. Measures were taken before, during, immediately after, and 2-3 months after training. Measures included walking progression, sitting balance, skin sensation, spasticity, and strength of the corticospinal tracts. RESULTS:Twelve participants were enrolled with 10 completing training. Training progression and walking ability: The progression in training indicated about 45 sessions to reach 80% of final performance in training. By the end of training, participants walked at speeds of 0.28-0.60 m/s, and distances of 0.74-1.97 km in 1 h. The effort of walking was about 3.3 times that for manual wheelchair propulsion. One non-walker with an incomplete injury became a walker without the ReWalk after training. Sensory and motor measures: Sitting balance was improved in some, as seen from the limits of stability and sway speed. Neuropathic pain showed no long term changes. Change in spasticity was mixed with suggestion of differences between those with high versus low spasticity prior to training. The strength of motor pathways from the brain to back extensor muscles remained unchanged. Adverse events: Minor adverse events were encountered by the participants and trainer (skin abrasions, non-injurious falls). Field testing: The majority of participants could walk on uneven surfaces outdoors. Some limitations were encountered in home-like environments. CONCLUSION:For individuals with severe SCI, walking proficiency in the ReWalk requires about 45 sessions of training. The training was accompanied by functional improvements in some, especially in people with incomplete injuries. TRIAL REGISTRATION:NCT02322125 Registered 22 December 2014.
| S-EPMC6868817 | biostudies-literature
Project description:Acute thoracolumbar spinal cord injury (SCI) is common in dogs frequently secondary to intervertebral disc herniation. Following severe injury, some dogs never regain sensory function to the pelvic limbs or tail and are designated chronically "deep pain negative." Despite this, a subset of these dogs develop spontaneous motor recovery over time including some that recover sufficient function in their pelvic limbs to walk independently without assistance or weight support. This type of ambulation is commonly known as "spinal walking" and can take up to a year or more to develop. This review provides a comparative overview of locomotion and explores the physiology of locomotor recovery after severe SCI in dogs. We discuss the mechanisms by which post-injury plasticity and coordination between circuitry contained within the spinal cord, peripheral sensory feedback, and residual or recovered supraspinal connections might combine to underpin spinal walking. The clinical characteristics of spinal walking are outlined including what is known about the role of patient or injury features such as lesion location, timeframe post-injury, body size, and spasticity. The relationship between the emergence of spinal walking and electrodiagnostic and magnetic resonance imaging findings are also discussed. Finally, we review possible ways to predict or facilitate recovery of walking in chronically deep pain negative dogs. Improved understanding of the mechanisms of gait generation and plasticity of the surviving tissue after injury might pave the way for further treatment options and enhanced outcomes in severely injured dogs.
| S-EPMC7479830 | biostudies-literature