Exoskeletal-assisted Walking Research Articles

Exoskeletal-Assisted Walking in Veterans With Paralysis: A Randomized Clinical Trial.

Robotic exoskeletons leverage technology that assists people with spinal cord injury (SCI) to walk. The efficacy of home and community exoskeletal use has not been studied in a randomized clinical trial (RCT). To examine whether use of a wheelchair plus an exoskeleton compared with use of only a wheelchair led to clinically meaningful net improvements in patient-reported outcomes for mental and physical health. This RCT of veterans with SCI was conducted at 15 Veterans Affairs medical centers in the US from September 6, 2016, to September 27, 2021. Data analysis was performed from March 10, 2022, to June 20, 2024. Participants were randomized (1:1) to standard of care (SOC) wheelchair use or SOC plus at-will use of a US Food and Drug Administration (FDA)-cleared exoskeletal-assisted walking (EAW) device for 4 months in the home and community. Two primary outcomes were studied: 4.0-point or greater improvement in the mental component summary score on the Veterans RAND 36-Item Health Survey (MCS/VR-36) and 10% improvement in the total T score of the Spinal Cord Injury-Quality of Life (SCI-QOL) physical and medical health domain and reported as the proportion who achieved clinically meaningful changes. The primary outcomes were measured at baseline, post randomization after advanced EAW training sessions, and at 2 months and 4 months (primary end point) in the intervention period. Device usage, reasons for not using, and adverse events were collected. A total of 161 veterans with SCI were randomized to the EAW (n = 78) or SOC (n = 83) group; 151 (94%) were male, the median age was 47 (IQR, 35-56) years, and median time since SCI was 7.3 (IQR, 0.5 to 46.5) years. The difference in proportion of successes between the EAW and SOC groups on the MCS/VR-36 (12 of 78 [15.4%] vs 14 of 83 [16.9%]; relative risk, 0.91; 95% CI, 0.45-1.85) and SCI-QOL physical and medical health domain (10 of 78 [12.8%] vs 11 of 83 [13.3%]; relative risk, 0.97; 95% CI, 0.44-2.15) was not statistically different. Device use was lower than expected (mean [SD] distance, 1.53 [0.02] miles per month), primarily due to the FDA-mandated companion being unavailable 43.9% of the time (177 of 403 instances). Two EAW-related foot fractures and 9 unrelated fractures (mostly during wheelchair transfers) were reported. In this RCT of veterans with SCI, the lack of improved outcomes with EAW device use may have been related to the relatively low device usage. Solutions for companion requirements and user-friendly technological adaptations should be considered for improved personal use of these devices. ClinicalTrials.gov Identifier: NCT02658656.

Exoskeletal-assisted walking combined with transcutaneous spinal cord stimulation to improve bone health in persons with spinal cord injury: study protocol for a prospective randomised controlled trial

IntroductionPersons with non-ambulatory spinal cord injury (SCI) undergo immediate unloading of the skeleton and, as a result, have marked loss of bone mineral density below the level of lesion that...

Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Enhances Recovery for Persons with Spinal Cord Injury-A Pilot Randomized Controlled Trial.

Spinal cord injury (SCI) negatively impacts individuals' functional independence, and motor and sensory function. Intense walking training has been shown to facilitate recovery for individuals with chronic SCI. Powered robotic exoskeletons provide therapists with a tool that allows them to conduct walking training with less therapist effort as compared to conventional walking training. Exoskeletal-assisted walking (EAW) has been studied in the chronic SCI population with preliminary reports showing benefits in mobility, health, and quality-of-life outcomes. However, few reports have studied EAW's benefits in the acute (<90 days post) SCI population at a time when neural plasticity is most dynamic and modifiable. The purpose of the study was to conduct a pilot randomized controlled trial (RCT) to understand the effects of incorporated EAW in acute inpatient rehabilitation (AIR) for individuals with SCI on functional, motor, and sensory recovery. The study outcomes included the Spinal Cord Independence Measure (SCIM) III and International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor and sensory scores that were assessed by unblinded assessors. We also recorded EAW session data, including adverse events, walking and up time, step counts, Borg Rating of Perceived Exertion (RPE), and compliance with scheduled EAW training. From August 2019 to July 2022, 16 participants completed the AIR with incorporated EAW, and 12 completed the standard AIR, all with SCI and preserved leg function within 90 days post-injury. During each session, the AIR with incorporated EAW group averaged 34.3 (±9.4) min of up time, 25.4 (±7.7) min of walk time, and 536 (±157) steps. Analysis via two-by-two mixed-effects models showed significant increases in the SCIM total score and ISNCSCI total motor and sensory scores over time for the AIR with incorporated EAW group [SCIM total score: F(1, 26) = 5.59, p = 0.03; total motor score: F(1, 26) = 8.06, p < 0.01; total sensory score: F(1, 19.2) = 5.08, p = 0.04], outperforming the standard AIR group. The AIR with incorporated EAW group showed 13, 14, and 22 points higher changes in the SCIM total score, total motor score, and total sensory score (respectively) by discharge compared with the standard AIR group. Incorporating EAW into AIR may facilitate functional, motor, and sensory recovery for individuals with SCI during AIR better than standard AIR. However, the study had a limited sample size. Further studies are needed to clarify the effects of EAW in AIR.

Comparison of the dynamics of exoskeletal-assisted and unassisted locomotion in an FDA-approved lower extremity device: Controlled experiments and development of a subject-specific virtual simulator.

Robotic exoskeletons have considerable, but largely untapped, potential to restore mobility in individuals with neurological disorders, and other conditions that result in partial or complete immobilization. The growing demand for these devices necessitates the development of technology to characterize the human-robot system during exoskeletal-assisted locomotion (EAL) and accelerate robot design refinements. The goal of this study was to combine controlled experiments with computational modeling to build a virtual simulator of EAL. The first objective was to acquire a minimum empirical dataset comprising human-robot kinematics, ground reaction forces, and electromyography during exoskeletal-assisted and unassisted locomotion from an able-bodied participant. The second objective was to quantify the dynamics of the human-robot system using a subject-specific virtual simulator reproducing EAL compared to the dynamics of normal gait. We trained an able-bodied participant to ambulate independently in a Food and Drug Administration-approved exoskeleton, the ReWalk P6.0 (ReWalk Robotics, Yoknaem, Israel). We analyzed the motion of the participant during exoskeletal-assisted and unassisted walking, sit-to-stand, and stand-to-sit maneuvers, with simultaneous measurements of (i) three-dimensional marker trajectories, (ii) ground reaction forces, (iii) electromyography, and (iv) exoskeleton encoder data. We created a virtual simulator in OpenSim, comprising a whole-body musculoskeletal model and a full-scale exoskeleton model, to determine the joint kinematics and moments during exoskeletal-assisted and unassisted maneuvers. Mean peak knee flexion angles of the human subject during exoskeletal-assisted walking were 50.1° ± 0.6° (left) and 52.6° ± 0.7° (right), compared to 68.6° ± 0.3° (left) and 70.7° ± 1.1° (right) during unassisted walking. Mean peak knee extension moments during exoskeletal-assisted walking were 0.10 ± 0.10 Nm/kg (left) and 0.22 ± 0.11 Nm/kg (right), compared to 0.64 ± 0.07 Nm/kg (left) and 0.73 ± 0.10 Nm/kg (right) during unassisted walking. This work provides a foundation for parametric studies to characterize the effects of human and robot design variables, and predictive modeling to optimize human-robot interaction during EAL.

Invasive and Non-Invasive Approaches of Electrical Stimulation to Improve Physical Functioning after Spinal Cord Injury.

This review of literature provides the latest evidence involving invasive and non-invasive uses of electrical stimulation therapies that assist in restoring functional abilities and the enhancement of quality of life in those with spinal cord injuries. The review includes neuromuscular electrical stimulation and functional electrical stimulation activities that promote improved body composition changes and increased muscular strength, which have been shown to improve abilities in activities of daily living. Recommendations for optimizing electrical stimulation parameters are also reported. Electrical stimulation is also used to enhance the skills of reaching, grasping, standing, and walking, among other activities of daily living. Additionally, we report on the use of invasive and non-invasive neuromodulation techniques targeting improved mobility, including standing, postural control, and assisted walking. We attempt to summarize the effects of epidural stimulation on cardiovascular performance and provide a mechanistic explanation to the current research findings. Future trends such as the combination of epidural stimulation and exoskeletal-assisted walking are also discussed.

Exoskeletal-assisted walking may improve seated balance in persons with chronic spinal cord injury: a pilot study.

Pre-post intervention. To explore the potential effect of exoskeletal-assisted walking (EAW) on seated balance for persons with chronic motor complete spinal cord injury (SCI). A SCI research center. Eight participants who were over 18 years of age with chronic SCI and used a wheelchair for mobility were enrolled. Seven able-bodied participants were used for normal seated balance comparative values. Participants with chronic SCI received supervised EAW training using a powered exoskeleton (ReWalkTM) for a median 30 sessions (range from 7 to 90 sessions). Before and after EAW training, seated balance testing outcomes were collected using computerized dynamic posturography, providing measurements of endpoint excursion (EPE), maximal excursion (MXE), and directional control (DCL). Modified functional reach test (MFRT) and the sub-scales of physical functioning and role limitations due to physical health from the Short Form (36) Health Survey (SF-36) were used to identify changes in functional activities. After EAW training, seated balance significantly improved in total-direction EPE and MXE (P < 0.01 and P < 0.017 respectively). The results of MFRT and sub-scales of physical functioning and role limitations due to physical health improved after EAW training but were not statistically significant. EAW training may have the potential to improve seated balance for persons with chronic motor complete SCI. Due to the limitations of the study, such as small sample size and lack of a control group, further studies are needed to clarify the effect of improving seated balance through EAW training.

The Effect of Exoskeletal-Assisted Walking on Spinal Cord Injury Bowel Function: Results from a Randomized Trial and Comparison to Other Physical Interventions.

Bowel function after spinal cord injury (SCI) is compromised because of a lack of voluntary control and reduction in bowel motility, often leading to incontinence and constipation not easily managed. Physical activity and upright posture may play a role in dealing with these issues. We performed a three-center, randomized, controlled, crossover clinical trial of exoskeletal-assisted walking (EAW) compared to usual activity (UA) in people with chronic SCI. As a secondary outcome measure, the effect of this intervention on bowel function was assessed using a 10-question bowel function survey, the Bristol Stool Form Scale (BSS) and the Spinal Cord Injury Quality of Life (SCI-QOL) Bowel Management Difficulties instrument. Fifty participants completed the study, with bowel data available for 49. The amount of time needed for the bowel program on average was reduced in 24% of the participants after EAW. A trend toward normalization of stool form was noted. There were no significant effects on patient-reported outcomes for bowel function for the SCI-QOL components, although the time since injury may have played a role. Subset analysis suggested that EAW produces a greater positive effect in men than women and may be more effective in motor-complete individuals with respect to stool consistency. EAW, along with other physical interventions previously investigated, may be able to play a previously underappreciated role in assisting with SCI-related bowel dysfunction.

Oxygen Uptake During Exoskeletal-Assisted Walking in Persons With Paraplegia

ObjectiveTo determine the cardiometabolic demands associated with exoskeletal-assisted walking (EAW) in persons with paraplegia. This study will further examine if training in the device for 60 sessions modifies cost of transport (CT). DesignProspective cohort study. Measurements over the course of a 60-session training program, approximately 20 sessions apart. SettingJames J. Peters Bronx Veterans Affairs Medical Center, Center for the Medical Consequences of Spinal Cord Injury Research Center. ParticipantsThe participants’ demographics (N=5) were 37-61 years old, body mass index (calculated as weight in kilograms divided by height in meters squared) of 22.7-28.6, level of injury from T1-T11, and 2-14 years since injury. InterventionsPowered EAW. Main Outcome MeasuresOxygen consumption per unit time (V˙O2, mL/min/kg), velocity (m/min), cost of transport (V˙O2/velocity), and rating of perceived exertion (RPE). ResultsWith training: EAW velocity significantly improved (Pre: 51±51m; 0.14±0.14m/s vs Post: 99±42m; 0.28±0.12m/s, P=.023), RPE significantly decreased (Pre: 13±6 vs Post: 7±4, P=.001), V˙O2 significantly improved (Pre: 9.76±1.23 mL/kg/m vs Post: 12.73±2.30 mL/kg/m, P=.04), and CT was reduced from the early to the later stages of training (3.66±5.2 vs 0.87±0.85 mL/kg/m). ConclusionsThe current study suggests that EAW training improves oxygen uptake efficiency and walking velocities, with a lower perception of exertion.

Effect of Exoskeletal-Assisted Walking on Soft Tissue Body Composition in Persons With Spinal Cord Injury

ObjectiveTo determine the effect of overground walking using a powered exoskeleton on soft tissue body composition in persons with spinal cord injury (SCI). DesignA prospective, single group observational pilot study. SettingMedical center. ParticipantsPersons (N=8) with chronic (>6mo) SCI between 18 and 65 years old who weighed less than 100 kg. InterventionsOverground ambulation training using a powered exoskeleton (ReWalk) for 40 sessions, with each session lasting up to 2 hours, with participants training 3 times per week. Main Outcome Measure(s)Dual-energy x-ray absorptiometry (DXA) was used to measure lean mass (LM) and fat mass (FM) from the whole body, arms, legs and trunk. DXA was also used to assess visceral adipose tissue (VAT). Walking performance was measured by 6-minute walk test. ResultsParticipants significantly lost total body FM (−1.8±1.2kg, P=.004) with the loss of adiposity distributed over several regional sites. Six of the 8 participants lost VAT, with the average loss in VAT trending toward significance (−0.141kg, P=.06). LM for the group was not significantly changed. ConclusionsSustained and weekly use of powered exoskeletons in persons with SCI has the potential to reduce FM with inferred improvements in health.

The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury

There are more than 300,000 estimated cases of spinal cord injury (SCI) in the United States, and approximately 27,000 of these are Veterans. Immobilization from SCI results in adverse secondary medical conditions and reduced quality of life. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care. Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints. Few studies have reported the safety and efficacy for use of these devices in the home and community environments, and none evaluated their impact on patient-centered outcomes through a randomized clinical trial (RCT). Absence of reported RCTs for powered exoskeletons may be due to a range of challenges, including designing, statistically powering, and conducting such a trial within an appropriate experimental framework. An RCT for the study of exoskeletal-assisted walking in the home and community environments also requires the need to address key factors such as: avoiding selection bias, participant recruitment and retention, training, and safety concerns, particularly in the home environment. These points are described here in the context of a national, multisite Department of Veterans Affairs Cooperative Studies Program-sponsored trial. The rationale and methods for the study design were focused on providing a template for future studies that use powered exoskeletons or other strategies for walking and mobility in people with immobilization due to SCI.

Mobility Skills With Exoskeletal-Assisted Walking in Persons With SCI: Results From a Three Center Randomized Clinical Trial.

Background: Clinical exoskeletal-assisted walking (EAW) programs for individuals with spinal cord injury (SCI) have been established, but many unknown variables remain. These include addressing staffing needs, determining the number of sessions needed to achieve a successful walking velocity milestone for ambulation, distinguishing potential achievement goals according to level of injury, and deciding the number of sessions participants need to perform in order to meet the Food and Drug Administration (FDA) criteria for personal use prescription in the home and community. The primary aim of this study was to determine the number of sessions necessary to achieve adequate EAW skills and velocity milestones, and the percentage of participants able to achieve these skills by 12 sessions and to determine the skill progression over the course of 36 sessions.Methods: A randomized clinical trial (RCT) was conducted across three sites, in persons with chronic (≥6 months) non-ambulatory SCI. Eligible participants were randomized (within site) to either the EAW arm first (Group 1), three times per week for 36 sessions, striving to be completed in 12 weeks or the usual activity arm (UA) first (Group 2), followed by a crossover to the other arm for both groups. The 10-meter walk test seconds (s) (10MWT), 6-min walk test meters (m) (6MWT), and the Timed-Up-and-Go (s) (TUG) were performed at 12, 24, and 36 sessions. To test walking performance in the exoskeletal devices, nominal velocities and distance milestones were chosen prior to study initiation, and were used for the 10MWT (≤ 40s), 6MWT (≥80m), and TUG (≤ 90s). All walking tests were performed with the exoskeletons.Results: A total of 50 participants completed 36 sessions of EAW training. At 12 sessions, 31 (62%), 35 (70%), and 36 (72%) participants achieved the 10MWT, 6MWT, and TUG milestones, respectively. By 36 sessions, 40 (80%), 41 (82%), and 42 (84%) achieved the 10MWT, 6MWT, and TUG criteria, respectively.Conclusions: It is feasible to train chronic non-ambulatory individuals with SCI in performance of EAW sufficiently to achieve reasonable mobility skill outcome milestones.

The safety and feasibility of a new rehabilitation robotic exoskeleton for assisting individuals with lower extremity motor complete lesions following spinal cord injury (SCI): an observational study.

A pre-post observational study. To evaluate the safety and feasibility of a new rehabilitation robotic device for assisting individuals with lower extremity motor complete lesions following spinal cord injury (SCI). Three hospitals in Sichuan Province, China. Individuals aged 15-75 years with an SCI between vertebrae six (T6) and lumbar 1 (L1) and complete motor paralysis participated in an exoskeletal-assisted walking (EAW) programme (2 weeks, 5 days/week, 30 min/day). Data were collected pre-, mid- (week 1) and post-intervention (week 2). Twenty-eight individuals (mean age = 41.3, 71% males) participated in the EAW programme. The distance walked during the 6-min walking test (6MWT) increased relative to that at baseline, during week 1 (13.0 ± 5.3 m) and week 2 (16.2 ± 5.3 m) when wearing the exoskeleton. The walking speed during the 10-m walking test (10MWT) increased from 0.039 ± 0.016 to 0.045 ± 0.016 m/s. The Hoffer walking ability grade, the Spinal Cord Independence Measure (SCIM), and the Walking Index for SCI II (WISCI II) changed after 2 weeks of EAW. No improvement in lower extremity motor score (LEMS) was observed. The rates of adverse events and serious adverse events were 21% and 4%, respectively. The EAW programme with the new robotic exoskeleton provided potential meaningful improvements in mobility for individuals with SCI and had few adverse events.

Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Leads to Motor and Functional Improvement in Persons With Spinal Cord Injury: A Pilot Study

ObjectiveTo explore the potential effects of incorporating exoskeletal-assisted walking (EAW) into spinal cord injury (SCI) acute inpatient rehabilitation (AIR) on facilitating functional and motor recovery when compared with standard of care AIR. DesignA quasi-experimental design with a prospective intervention group (AIR with EAW) and a retrospective control group (AIR only). SettingSCI AIR facility. ParticipantsTen acute inpatient participants with SCI who were eligible for locomotor training were recruited in the intervention group. Twenty inpatients with SCI were identified as matched controls by reviewing an AIR database, Uniform Data System for Medical Rehabilitation, by an individual blinded to the study. Both groups (N=30) were matched based on etiology, paraplegia/tetraplegia, completeness of injury, age, and sex. InterventionEAW incorporated into SCI AIR. Main Outcome MeasuresFIM score, International Standards for Neurological Classification of Spinal Cord Injury Upper Extremity Motor Score and Lower Extremity Motor Scores (LEMS), and EAW session results, including adverse events, walking time, and steps. ResultsChanges from admission to discharge LEMS and FIM scores were significantly greater in the intervention group (LEMS change: 14.3±10.1; FIM change: 37.8±10.8) compared with the control group (LEMS change: 4.6±6.1; FIM change: 26.5±14.3; Mann-Whitney U tests: LEMS, P<.01 and FIM, P<.05). One adverse event (minor skin abrasion) occurred during 42 walking sessions. Participants on average achieved 31.5 minutes of up time and 18.2 minutes of walk time with 456 steps in one EAW session. ConclusionsIncorporation of EAW into standard of care AIR is possible. AIR with incorporated EAW has the potential to facilitate functional and motor recovery compared with AIR without EAW.

Changes in bowel function following exoskeletal-assisted walking in persons with spinal cord injury: an observational pilot study.

Study DesignProspective, observational studyObjectiveTo explore the effects of exoskeleton-assisted walking (EAW) on bowel function in persons with spinal cord injury (SCI).SettingAmbulatory research facility located in a tertiary care hospitalMethodsIndividuals 18–65 years of age, with thoracic vertebrae one (T1) to T11 motor-complete paraplegia of at least 12 months duration were enrolled. Pre- and post-EAW training, participants were asked to report on various aspects of their bowel function as well as on their overall quality of life (QOL) as related to their bowel function.ResultsTen participants completed 25–63 sessions of EAW over a period of 12 to 14 weeks, one participant was lost to follow up due to early withdrawal after 10 sessions. Due to the small sample size, each participant’s results were presented descriptively in a case series format. At least 5/10 participants reported improvements with frequency of bowel evacuations, less time spent on bowel management per bowel day, fewer bowel accidents per month, reduced laxative and/or stool softener use, and improved overall satisfaction with their bowel program post-EAW training. Furthermore, 8/10 reported improved stool consistency and 7/10 reported improved bowel function related QOL. One participant reported worsening of bowel function post-EAW.ConclusionBetween 50 and 80% of the participants studied reported improvements in bowel function and/or management post-EAW training. EAW training appeared to mitigate SCI-related bowel dysfunction and the potential benefits of EAW on bowel function after SCI is worthy or further study.SponsorshipN/A

Relationships between T-scores at the hip and bone mineral density at the distal femur and proximal tibia in persons with spinal cord injury

Objective: To identify T-score values at the total hip (TH) and femoral neck (FN) that correspond to the cutoff value of <0.60 g/cm2 for heightened risk of fracture at the distal femur (DF) and proximal tibia (PT). Design: Retrospective analysis of data in a research center’s database. Setting: Community-based individuals with spinal cord injury (SCI). Participants: 105 unique individuals with SCI. Outcome Measurements: DXA derived areal BMD (aBMD) and T-score of the DF, PT, TH, and FN. Results: The aBMD at the DF and PT regions were predictors of T-scores at the TH (R 2 = 0.63, P < 0.001 and R 2 = 0.65, P < 0.001) and FN (R 2 = 0.55, P < 0.001 and R 2 = 0.58, P < 0.001). Using the DF and PT aBMD of 0.60 g/cm2 as a value below which fractures were more likely to occur, the predicted T-score was −3.1 and −3.5 at the TH and −2.6 and −2.9 at the FN, respectively. However, when the predicted and observed T-score values disagree outside the 95% limit of agreement, the predicted T-score values are lower than the measured T-score values, overestimating the measured values between −2.0 and −4.0 SD. Conclusion: The DF and PT cutoff value for aBMD of 0.60 g/cm2 was a moderate predictor of T-score values at the TH and FN, with considerable inaccuracies outside the clinically acceptable limits of agreement. As such, the direct measurement of knee aBMD in persons with SCI should be performed, whenever possible, prior to prescribing weight bearing upright activities, such as robotic exoskeletal-assisted walking.

The Safety and Feasibility of Exoskeletal-Assisted Walking in Acute Rehabilitation After Spinal Cord Injury

ObjectiveTo assess safety and feasibility for persons with acute spinal cord injury (SCI) using the robotic exoskeleton. DesignCase series observational study. SettingA level-1 trauma center in Canada with both acute and tertiary inpatient SCI rehabilitation units. ParticipantsEight male and 3 female (N=11) participants were recruited with a mean age of 41 years and with neurologic level of injury (C6-L2) and severity (American Spinal Injury Association Impairment Scale [AIS] A-D). The time since injury is a range of 3-15 weeks at the onset of training. InterventionsUp to 25 one-hour sessions of exoskeletal-assisted walking gait training, with participants less than 6 months from initial SCI. Main Outcome MeasuresCardiopulmonary outcomes including blood pressure, heart rate, and peripheral oxygen saturation; and perceived physical exertion using the Borg CR10 Scale were recorded. Gait parameters were measured by 6-minute walk test (6MWT) and 10-meter walk test (10MWT). Up Time, walk time, and number of steps were detailed longitudinally. Safety was assessed with regard to pain, falls, and skin integrity. ResultsNo serious adverse events occurred. Blood pressure decreased following initial sit to stand and increased during walking. Symptoms of hypotension were rare and improved with increased number of sessions. Perceived exertion was reported on average to be moderate (mean of 3.1). There was no significant increase in pain scores by Visual Analog Scale. On 6MWT, participants covered more distance (mean [m] ± SD, 117.1±11.7) in session 25 compared to session 2 (mean [m] ± SD, 47.6±6.6). On the 10MWT, all participants showed consistently improved gait speed; with participants traveling an average of 3.2 times faster during their last training session (mean [m/s] ± SD, 0.40±0.04) in comparison to session 2 (mean [m/s] ± SD, 0.12±0.01). ConclusionsExoskeletal-assisted walking in acute rehabilitation (<6mo) following SCI appears to be both safe and feasible.

Decreased total and central adiposity after 100 exoskeletal-assisted walking sessions in persons with chronic spinal cord injury

Introduction In persons with spinal cord injury (SCI), paralysis results in extreme physical inactivity and a higher percent of body fat. The accumulation of excess fat in the visceral cavity is a primary contributor to metabolic abnormalities and an increased risk of cardiovascular disease (CVD), one of the leading causes of death in the SCI population. Powered exoskeleton-assisted walking (EAW) are robotic devises that promote exercise through rehabilitation and overground walking that may have positive effects on body composition and cardiometabolic health. Objective The purpose of this prospective observational study was to determine changes in total body fat mass (TBFmass), total body fat percent (TBF%), android adipose tissue percent (AAT%), visceral adipose tissue percent (VAT%), and subcutaneous adipose tissue percent (SAT%) after 100 sessions of powered EAW in persons with chronic SCI. Design/Method This prospective single arm intervention study was performed in 8 participants with chronic SCI (>12 months). Participants trained in a robotic exoskeleton (Ekso, Ekso Bionics, Richmond, CA, USA) with each loading session lasting 1-hour, 3-4 times a week, for a total of 100 1-hour sessions. Measures of TBF, TBF%, AAT%, VAT%, and SAT% were obtained prior to training (PRE) and immediately after 100 sessions of EAW (POST) using dual energy x-ray absorptiometry (DXA, GE Lunar iDXA, enCore and CoreScan, platform version 14.0, Madison, WI). Paired t-tests were performed to determine significant differences in the absolute pre-post values and the a priori level of significance was set at p Results Compared to the PRE training values, adiposity POST training was significantly decreased in TBF (pre vs. post: 28.7 ± 7.3 vs. 26.5 ± 7.5 kg, p Conclusions EAW training provided sufficient energy expenditure to reduce total body adiposity and most of the measures of central adiposity. Decreased adiposity would be expected to be associated with reduced risk of metabolic syndrome and CVD.

In-Hospital Exoskeletal-Assisted Walking Velocity and Level of Assistance Assessment in Persons with Spinal Cord Injury

In-Hospital Exoskeletal-Assisted Walking Velocity and Level of Assistance Assessment in Persons with Spinal Cord Injury

Assessment of In-Hospital Walking Velocity and Level of Assistance in a Powered Exoskeleton in Persons with Spinal Cord Injury.

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.