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Importance: 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). Objective: 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. Design, Setting, and Participants: 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. Interventions: 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. Main Outcomes and Measures: 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. Results: 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. Conclusions and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT02658656.

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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.

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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.

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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.

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Objective: To determine the reliability of peak VO2 testing for individuals with spinal cord injury (SCI) in deep water and on land; and to examine the relationship between these two testing conditions. Design: Reliability study. Setting: Comprehensive rehabilitation center in Baltimore, MD, USA. Participants: 17 participants (13 men, 4 women) with motor complete and incomplete SCI. Participants were randomized into either aquatic or arm cycle ergometer first measurements. Intervention: Pilot study to assess peak VO2. Outcome measures: Peak VO2 measured with metabolic cart in supported deep water with the addition of Aquatrainer® connection, and on land with arm cycle ergometer. Two trials were conducted for each condition with 48 h separating each test. Results: Peak oxygen consumption reliability was statistically significant for both conditions, aquatic (r = 0.93, P < 0.001) and arm cycle ergometry (r = 0.96, P < 0.001). Additionally, aquatic and arm cycle peak VO2 correlation existed (r = 0.72, P < 0.001). For these 17 participants, lower extremity motor score influenced supported, deep water peak VO2, B = 0.57, P < 0.02, whereas age, sex, and weight did not impact deep water or ergometer values. Conclusion: Determining peak VO2 for individuals with SCI is highly reproducible for arm cycle ergometry and in deep water assessment. Additionally, aquatic, deep water peak VO2 testing is valid when compared to arm cycle ergometry. Although the peak VO2 relationship between deep water and arm cycle ergometry is high, variance in the two conditions does exist. Therefore, it is important to assess peak VO2 via the same exercise modality utilized in the treatment intervention.

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STUDY DESIGN: Randomized dual center controlled clinical trial. OBJECTIVE: To determine and compare the cardiorespiratory impact of 3 months of aquatic and robotic therapy for individuals with chronic motor incomplete spinal cord injury (CMISCI). SETTINGS: Two rehabilitation specialty hospitals. METHODS: Thirty-one individuals with CMISCI with neurological level between C2-T12 at least 1 year post injury were randomized to either aquatic or robotic treadmill therapy for 36 sessions. Customized sessions lasted 40-45 min at 65-75% heart rate reserve intensity with peak oxygen consumption (peak VO2) measured during arm ergometry at baseline and post intervention. Additional peak robotic treadmill VO2 assessments were obtained before and after training for participants randomized to robotic intervention. RESULTS: Peak VO2 measured with arm ergometry was not significantly different with either aquatic intervention (8.1%, p = 0.14, n = 15) or robotic intervention (-0.7%, p = 0.31, n = 17). Peak VO2 measured with robotic treadmill ergometry demonstrated a statistical improvement (14.7%, p = 0.03, n = 17, two-tailed t-test) across the robotic intervention. Comparison between the two interventions demonstrated a trend favoring aquatic therapy for improving arm ergometry peak VO2 (ANOVA, p = 0.063). CONCLUSIONS: Neither 3-month exercise interventions statistically improved arm cycle ergometry peak VO2, our cardiorespiratory surrogate marker, although percent improvement was greater in the aquatic exercise condition. Robotic ergometry peak VO2 did improve for the robotic intervention, confirming previous work. These results suggest that either intervention may hold utility in improving cardiorespiratory fitness in CMISCI, but peak VO2 measurement technique appears critical in detecting effects. SPONSORSHIP: DOD CDMRP SCI Research Program Clinical Trial Award SC090147, FY 2009. This study is registered under ClinicalTrials.gov Identifier: NCT01407354.

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OBJECTIVE: To obtain preliminary data on the effects of an auricular acupuncture protocol, Battlefield Acupuncture (BFA), on self-reported pain intensity in persons with chronic Spinal Cord Injury (SCI) and neuropathic pain. DESIGN: Pilot randomized delayed entry single center crossover clinical trial at an outpatient rehabilitation and integrative medicine hospital center. METHODS: Chronic (> one year post injury) ASIA impairment scale A through D individuals with SCI with injury level from C3 through T12 and below level neuropathic pain with at least five on the Numeric Rating Scale (NRS) were recruited. Twenty-four subjects were randomized to either an eight-week once weekly ten-needle BFA protocol (n = 13) or to a waiting list followed by the BFA protocol (n = 11). OUTCOME MEASURES: The primary outcome measure was change in the pain severity NRS. Secondary outcome was the Global Impression of Change. RESULTS: Demographically there were no significant differences between groups. Mean pain scores at baseline were higher in acupuncture than control subjects (7.75 ± 1.54 vs. 6.25 ± 1.04, P = 0.027). Although both groups reported significant reduction in pain during the trial period, the BFA group reported more pain reduction than the delayed entry group (average change in NRS at eight weeks -2.92 ± 2.11 vs. -1.13 ± 2.14, P = 0.065). There was a significant difference in groups when a group-by-time interaction in a mixed-effect repeated measures model (P = 0.014). CONCLUSION: This pilot study has provided proof of concept that BFA has clinically meaningful effect on the modulation of SCI neuropathic pain.

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OBJECTIVE: To assess the effectiveness of robotically assisted body weight supported treadmill training (RABWSTT) for improving cardiovascular fitness in chronic motor incomplete spinal cord injury (CMISCI). DESIGN: Pilot prospective randomized, controlled clinical trial. SETTING: Outpatient rehabilitation specialty hospital. PARTICIPANTS: Eighteen individuals with CMISCI with American Spinal Injury Association (ASIA) level between C4 and L2 and at least one-year post injury. Interventions CMISCI participants were randomized to RABWSTT or a home stretching program (HSP) three times per week for three months. Those in the home stretching group were crossed over to three months of RABWSTT following completion of the initial three month phase. OUTCOME MEASURES: Peak oxygen consumption (peak VO(2)) was measured during both robotic treadmill walking and arm cycle ergometry: twice at baseline, once at six weeks (mid-training) and twice at three months (post-training). Peak VO(2) values were normalized for body mass. RESULTS: The RABWSTT group improved peak VO(2) by 12.3% during robotic treadmill walking (20.2 ± 7.4 to 22.7 ± 7.5 ml/kg/min, P = 0.018), compared to a non-significant 3.9% within group change observed in HSP controls (P = 0.37). Neither group displayed a significant change in peak VO2 during arm cycle ergometry (RABWSTT, 8.5% (P = 0.25); HSP, 1.76% (P = 0.72)). A repeated measures analysis showed statistically significant differences between treatments for peak VO(2) during both robotic treadmill walking (P = 0.002) and arm cycle ergometry (P = 0.001). CONCLUSION: RABWSTT is an effective intervention model for improving peak fitness levels assessed during robotic treadmill walking in persons with CMISCI.

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CONTEXT/OBJECTIVE: A 41-year-old man with a history of C6 American Spinal Injury Association (ASIA) Impairment Scale (AIS) C spinal cord injury (SCI), enrolled in an Institutional Review Board (IRB)-approved, robotic-assisted body weight-supported treadmill training (BWSTT), and aquatic exercise research protocol developed asymptomatic autonomic dysreflexia (AD) during training. Little information is available regarding the relationship of robotic-assisted BWSTT and AD. FINDINGS: After successfully completing 36 sessions of aquatic exercise, he reported exertional fatigue during his 10th Lokomat intervention and exhibited asymptomatic or silent AD during this and the three subsequent BWSTT sessions. Standard facilitators of AD were assessed and no obvious irritant identified other than the actual physical exertion and positioning required during robotic-assisted BWSTT. CONCLUSIONS/CLINICAL RELEVANCE: Increased awareness of potential silent AD presenting during robotic assisted BWSTT training for individuals with motor incomplete SCI is required as in this case AD clinical signs were not concurrent with occurrence. Frequent vital sign assessment before, during, and at conclusion of each BWSTT session is strongly recommended.

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Individuals with spinal cord injury or dysfunction represent unique diagnostic challenges when they present with symptoms of generalized malaise or "feeling lousy." Those individuals with injury or dysfunction at or above the T6 level are specifically at risk for the phenomenon known as autonomic dysreflexia, which is a medical emergency. The underlying cause of autonomic dysreflexia as well as other secondary complications in the patient with a spinal cord injury can best be uncovered through a comprehensive review of systems, which encompasses constitutional, head, cardiovascular, gastrointestinal, genitourinary, musculoskeletal, respiratory, skin, neurologic, psychiatric, endocrinologic, hematologic, and immunologic issues.

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SETTING: Outpatient clinic of a spinal cord injury rehabilitation center. DESIGN: Case report. PARTICIPANT: A 40-year-old man with a 20-year history of C4 complete tetraplegia complained of 5 years of excessive intermittent left-sided sweating. The sweating occurred only in the seated upright position. There was no associated headache, blurred vision, or blood pressure variability. FINDINGS: When examined upright, the patient sweated excessively on the left face and body. When he was laid down, sweating ceased. Skin examination revealed intact ischial regions. Pressure applied to the right ischium for several minutes caused sweating to recur on the left forehead, but it then subsided with release of pressure. This phenomenon was repeatable. Local lidocaine injection in the subcutaneous tissues around the right ischium and subsequent use of lidocaine transdermal patches halted the contralateral sweating in the upright position. Pressure mapping analysis showed increased pressure in the region of the right ischial tuberosity. The patient's gel cushion was replaced with an air-filled cushion, providing significant ongoing relief from the hyperhidrosis. CONCLUSION/CLINICAL RELEVANCE: Unilateral hyperhidrosis can be caused by a contralateral source of irritation. Use of techniques that interrupt the afferent arm of the autonomic pathway may be effective in the management of hyperhidrosis in individuals with spinal cord injury.

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BACKGROUND: To determine whether the prophylactic placement of an inferior vena cava (IVC) filter after acute spinal cord injury (SCI) causes an increased incidence of deep venous thrombosis (DVT). METHODS: A retrospective chart review was conducted employing charts from patients admitted to the SCI service of one inpatient rehabilitation center for 2 consecutive years. One hundred fourteen subjects met inclusion criteria, namely an acute SCI, length of rehabilitation stay greater than 7 days, and level of injury between C3 and L3. Subjects were classified into two groups: those who received a prophylactic IVC filter during their acute stay and those that did not. The occurrence of DVT during initial rehabilitation was the primary outcome measure. Other demographic and medical information including the occurrence of pulmonary embolism were also collected. RESULTS: Of the 114 subjects, two were excluded because of DVT occurring before rehabilitation admission. Of the remainder, 54 (47%) had prophylactic IVC filters placed. Of those with filters, 11 (20.4%) experienced a DVT during their rehabilitation stay. Of the 58 without filters, only three (5.2%) experienced a DVT during rehabilitation (p = 0.021, Fisher's exact test). Confounding factors included the Injury Severity Score and possibly the cause of injury and presence of long bone fracture. Only one individual experienced pulmonary embolism during rehabilitation hospitalization, and that was in a person with a prophylactic IVC filter. CONCLUSIONS: The presence of prophylactic IVC filters in acute SCI patients may actually increase the risk of DVT, which has its own associated morbidities and costs.

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OBJECTIVES: To estimate the prevalence of and determine risk factors for Staphylococcus aureus colonization of the perineum. DESIGN: Cross-sectional study with follow-up of up to 1 year. SETTING: Multiple outpatient sites. PARTICIPANTS: Eighty-four community-dwelling adults with spinal cord dysfunction (SCD). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Colonization of perineum with S. aureus. RESULTS: Overall, 24% of the study cohort carried S. aureus on their perineal skin at enrollment, with 16% having methicillin-susceptible S. aureus and 10% having methicillin-resistant S. aureus (MRSA). Most perineal carriers were also colonized in the anterior nares. Participants with trauma as the cause of their SCD were more likely to be colonized with S. aureus than participants with SCD caused by multiple sclerosis or other causes (relative risk [RR], 2.8; 95% confidence interval [CI], 1.2-6.6; P=.01). Participants with pelvic decubiti were more likely to be colonized with S. aureus than participants without pelvic decubiti (RR=4.3; 95% CI, 2.4-7.7; P<.001). The recent use of any antibiotic was not associated with an increased risk of colonization with S. aureus (RR=1.5; 95% CI, 0.7-3.3; P=.31); however, recent fluoroquinolone use was significantly associated with perineal colonization (RR=2.8; 95% CI, 1.4-5.8; P=.02). Of the 8 participants with MRSA colonization, only 2 (25%) had a history of MRSA colonization. CONCLUSIONS: S. aureus colonization of the perineum is common in this outpatient population of people with SCD. The use of fluoroquinolones was associated with S. aureus colonization. Colonization with MRSA without a history of MRSA was common.

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OBJECTIVES: To estimate the prevalence of colonization with fluoroquinolone-resistant gram-negative bacilli (GNB) and to assess risk factors for and define the natural history of colonization. DESIGN: Cross-sectional study with follow-up of up to 1 year. SETTING: Multiple outpatient sites. PARTICIPANTS: Eighty-four community-dwelling adults with spinal cord dysfunction. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Colonization of perineum with fluoroquinolone-resistant GNB. RESULTS: Overall, 24% of this community-dwelling cohort was colonized with fluoroquinolone-resistant GNB with resistance to both levofloxacin and gatifloxacin. The use of any antibiotic in the last 90 days was most strongly associated with an increased risk of colonization with fluoroquinolone-resistant GNB (relative risk, 2.3; 95% confidence interval, 1.1-4.8; P=.05). Incontinence was significantly more common among those with fluoroquinolone-resistant GNB colonization. Among the participants with incontinence (n=42), the use of intermittent catheterization (vs suprapubic, urethral, or condom catheters or overflow incontinence) was significantly protective. Colonization was not associated with an increase in urinary tract infection and was often transient. CONCLUSIONS: Fluoroquinolone resistance among GNB colonizing community-dwelling people with spinal cord dysfunction is common. Colonization is more common among those receiving antibiotics and less common among those continent of urine. Among those with incontinence, those using intermittent catheterization have less colonization.

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