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Synchrotron X-ray computed tomography (SXCT) allows 3D imaging of tissue with a very large field of view and an excellent micron resolution and enables the investigation of muscle fiber atrophy in 3D. The study aimed to explore the 3D micro-architecture of healthy skeletal muscle fibers and muscle fibers at different stages of atrophy (stroke sample = muscle atrophy; spinal cord injury (SCI) sample = severe muscle atrophy). Three muscle samples: a healthy control sample; a stroke sample (atrophic sample), and an SCI sample (severe atrophic sample) were imaged using SXCT, and muscle fiber populations were segmented and quantified for microarchitecture and morphology differences. The volume fraction of muscle fibers was 74.7%, 70.2%, and 35.3% in the healthy, stroke (atrophic), and SCI (severe atrophic) muscle fiber population samples respectively. In the SCI (severe atrophic sample), 3D image analysis revealed fiber splitting and fiber swelling. In the stroke sample (atrophic sample) muscle fiber buckling was observed but was only visible in the 3D analysis. 3D muscle fiber population analysis revealed new insights into the different stages of muscle fiber atrophy not to be observed nor quantified with a 2D histological analysis including fiber buckling, loss of fibers and fiber splitting.

Study design A nationwide population-based register study. Objectives To investigate the socioeconomic consequences of traumatic (tSCI) and non-traumatic (ntSCI) spinal cord injuries (SCI) in relation to health care costs, risk of job loss, and divorce. Setting Denmark. Methods All survivors admitted for specialized SCI rehabilitation from 2008 to 2018 were included (n = 1751), together with their relatives (n = 3084). Control groups for the SCI group (n = 8139) and their relatives (n = 15,921) were identified. Data on socioeconomics up to 2 years before and up to 4 years after the injury year were included. Results Survivors of tSCI and ntSCI had significantly increased health care costs 2 years before injury compared to their controls, and increased health care cost was maintained 4 years after the injury (all p values < 0.0001). The SCI group had significantly increased risk of job loss (OR = 9.26; 95% CI: 7.70-11.15) and higher risk of divorce (OR = 1.44; 95% CI: 1.08-1.87) the 3 following years after injury compared to controls, but risk of divorce was only significant for the ntSCI group (OR = 1.58; 95% CI: 1.09-2.29). No significant differences on health care cost and job loss between the group of relatives of SCI survivors and their controls were found, except for the relatives (n = 1604) of SCI survivors

High level spinal cord injury drastically reduces the quality of life of the injured person. Various systems attempted to interface the still intact or residual abilities following injury in various monomodal or multimodal designs to compensate for the highly affected mobility. An intra-oral inductive tongue computer interface (ITCI) has been designed to provide real-time discrete and proportional control for computers and assistive devices and to meet specific requirements for individuals with tetraplegia. Operation of the ITCI for wheelchair control was demonstrated with two participants with tetraplegia in a short-term training study. Additionally, two non-disabled individuals participated in the study. For each participant, the ability to drive a Permobil C500 with the ITCI was compared to that when driving the wheelchair with joystick (mouth-stick in one case) along two different lanes of 39 m, by reporting the speed along the lanes and the number of obstacles hit. The lanes consisted of 90°, 360°, and complex maneuver segments linked by linear segments. The ITCI featured a mouthpiece encapsulating two pads of inductive sensors, driving electronics, and battery. The mouthpiece was attached to the palate of the participant's oral cavity with dental retainers. A piercing-like activation unit was attached to the tongue. Data were transmitted wirelessly to a central unit that controlled the wheelchair through wired interface. Among all participants, mean speeds along lane A or B reached maximal values between 0.42 and 0.74 m/s when driving with the ITCI, representing 41 to 71% of that obtained when driving with the joystick.

Design: Descriptive. Setting: Community, Bangladesh. Objectives: To determine the costs associated with providing a community-based model of care delivered as part of the CIVIC trial to people discharged from hospital with recent spinal cord injury (SCI), and to determine the economic burden to households. Methods: Records were kept of the costs of providing a community-based model of care to participants of the CIVIC trial. Data were also collected at discharge and 2 years post discharge to capture out-of-pocket healthcare costs over the preceding 2 years, and the number of participants suffering catastrophic health expenditure and illness-induced poverty. Results: The mean cost of providing the community-based model of care to participants assigned to the intervention group (n = 204) was US$237 per participant. The mean out-of-pocket healthcare cost over the first 2 years post discharge was US$472 per participant (n = 410), and US$448 per control participant (n = 206). Median (IQR) equivalent annual household incomes prior to SCI and at 2 years post discharge were US$721 (US$452–1129) and US$464 (US$214–799), respectively. Of the 378 participants alive at 2 years, 324 (86%) had catastrophic health expenditure, and 161 of 212 participants who were not in poverty prior to injury (76%) were pushed into illness-induced poverty within 2 years of injury. Conclusion: The cost of providing community-based support to people with SCI for 2 years post discharge in Bangladesh is relatively inexpensive but an overwhelming majority of households rapidly experience financial catastrophe, and most fall into poverty.

Study design: Randomised controlled trial. Objectives: To determine the effectiveness of a sustainable community-based intervention designed to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh. Setting: Bangladesh. Methods: A pragmatic randomised controlled trial was undertaken. People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh were recruited and randomised to an Intervention or Control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia). Participants in the Intervention group received 36 phone calls and three home visits over the first 2 years following discharge. All participants received usual post-discharge care. Survival status and date of death were determined by blinded assessors 2 years after randomisation. Results: Between July 2015 and March 2018, 410 participants were randomised (204 to Intervention, 206 to Control). There was no loss to follow up. At 2 years, 15 (7.4%) participants in the Intervention group and 16 (7.8%) participants in the Control group had died (hazard ratio from unadjusted Cox model = 0.93 [95% CI, 0.46 to 1.89]; p from log rank test 0.85). There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications. Conclusion: A program of community-based care for people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital is no better at preventing death at 2 years than usual care.

Objective: To provide an overview of clinical assessments and diagnostic tools, self-report measures (SRMs) and data sets used in neurogenic bladder and bowel (NBB) dysfunction and recommendations for their use with persons with spinal cord injury /disease (SCI/D). Methods: Experts in SCI/D conducted literature reviews, compiled a list of NBB related assessments and measures, reviewed their psychometric properties, discussed their use in SCI/D and issued recommendations for the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) guidelines. Results: Clinical assessments included 15 objective tests and diagnostic tools for neurogenic bladder and 12 for neurogenic bowel. Following a two-phase evaluation, eight SRMs were selected for final review with the Qualiveen and Short-Form (SF) Qualiveen and the Neurogenic Bowel Dysfunction Score (NBDS) being recommended as supplemental, highly-recommended due to their strong psychometrics and extensive use in SCI/D. Two datasets and other SRM measures were recommended as supplemental. Conclusion: There is no one single measure that can be used to assess NBB dysfunction across all clinical research studies. Clinical and diagnostic tools are here recommended based on specific medical needs of the person with SCI/D. Following the CDE for SCI studies guidelines, we recommend both the SF-Qualiveen for bladder and the NBDS for bowel as relatively short measures with strong psychometrics. Other measures are also recommended. A combination of assessment tools (objective and subjective) to be used jointly across the spectrum of care seems critical to best capture changes related to NBB and develop better treatments.

Design: Mixed methods study Setting: Community, Bangladesh Objectives: To understand how a community-based intervention for people with spinal cord injury (SCI) in Bangladesh was delivered as part of a randomised controlled trial and to gauge the perceptions of participants and healthcare professionals to the intervention. Methods: A community-based intervention was administered to 204 participants as part of a large randomised controlled trial (called the CIVIC trial). Case-managers followed-up participants with regular telephone calls and home visits over the first 2 years after discharge. The following data were collected alongside the trial: (i) chart audit of telephone calls and home visits (ii) recordings of 20 telephone calls (iii) interviews with 14 Intervention participants and four healthcare professionals including three case-managers. Results: Participants received the target number of telephone calls and home visits. Pressure injuries were identified as a problem during at least one telephone call by 43% of participants. Participants and case-managers valued regular telephone calls and home visits, and believed that calls and visits prevented complications and alleviated social isolation. Participants trusted case-managers and were confident in the care and advice provided. Case-managers expressed concerns that people with SCI in Bangladesh face many problems impacting on well-being and motivation stemming from poverty, limited employment opportunities, societal attitudes and inaccessible environments. Conclusion: A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care. Nonetheless, people with SCI in Bangladesh face economic and social problems which cannot be fully addressed by this type of intervention alone.

This study examined if acquiring a traumatic brain injury (TBI) increases utilization of health care costs, increases risk of job loss for the patient and the closest relatives, and increases the risk of divorce 1 to 5 years following the injury. The study was conducted as a Danish national population-based register study with follow-up. Participants included a cohort of patients with TBI (n = 18,328) admitted to a hospital or treated in an emergency room (ER) and a matching control group (n = 89,155). For both the TBI group and the matching controls, relatives were identified, using national registers (TBI relatives: n = 25,708 and control relatives: n = 135,325). The outcome measures were utilization of health care costs (including hospital services, use of general practitioner and practicing specialists, and prescribed medication), risk of job loss, and risk of divorce among the TBI group and the control group and their relatives. Patients with TBI had significantly increased health care costs at baseline (i.e., the year before the injury) and during the following 4 years. Further, TBI relatives had a significantly higher utilization of health care costs the first and the third year after injury. The TBI group had a significant increased risk of job loss (odds ratio [OR] = 2.88; confidence interval [CI]: 2.70-3.07) and divorce (OR = 1.44; CI: 1.27-1.64) during the first 3 years following injury. In conclusion, the TBI group had significantly higher utilization of health care costs, both pre-morbidly and post-injury. Further, increased risk of job loss and divorce were found, emphasizing that the socioeconomic consequences of TBI last for years post-injury.

OBJECTIVES: To (1) compare energy expenditure during seated rest, standing, and prolonged bionic ambulation or bipedal ambulation in participants with spinal cord injury (SCI) and noninjured controls, respectively, and (2) test effects on postbionic ambulation glycemia in SCI.DESIGN: Two independent group comparison of SCI and controls.SETTING: Academic Medical Center.PARTICIPANTS: Ten participants with chronic SCI (C7-T1, American Spinal Injury Association Impairment Scale A-C) and 10 controls (N=20).INTERVENTIONS: A commercial bionic exoskeleton.MAIN OUTCOME MEASURES: Absolute and relative (to peak) oxygen consumption, perceived exertion, carbohydrate/fat oxidation, energy expenditure, and postbionic ambulation plasma glucose/insulin.RESULTS: Average work intensity accompanying 45 minutes of outdoor bionic ambulation was <40% peak oxygen consumption, with negligible drift after reaching steady state. Rating of perceived exertion (RPE) did not differ between groups and reflected low exertion. Absolute energy costs for bionic ambulation and nonbionic ambulation were not different between groups despite a 565% higher ambulation velocity in controls and 3.3× higher kilocalorie per meter in SCI. Fuel partitioning was similar between groups and the same within groups for carbohydrate and fat oxidation. Nonsignificant (9%) lowering of the area under a glucose tolerance curve following bionic ambulation required 20% less insulin than at rest.CONCLUSION: Work intensity during prolonged bionic ambulation for this bionic exoskeleton is below a threshold for cardiorespiratory conditioning but above seated rest and passive standing. Bionic ambulation metabolism is consistent with low RPE and unchanged fuel partitioning from seated rest. Bionic ambulation did not promote beneficial effects on glycemia in well-conditioned, euglycemic participants. These findings may differ in less fit individuals with SCI or those with impai

Introduction: Spinal cord injury (SCI) predisposes those who suffer from it to physical inactivity and weight gain; consequently, death due to cardiovascular diseases is more frequent among people with SCI than in the general population. The literature documents a consensus about an interdisciplinary multimodal approach for the prevention and treatment of cardiovascular risk factors including overweight and obesity in people with SCI, focusing on diet, physical activity (PA) and behavioural interventions. This study will investigate implementation of recommendations from a recent clinical practice guideline for identification and management of cardiometabolic risk after SCI through multimodal patient education in a subacute clinical setting. Methods and analysis: All patients who are aged 18 years or older with an SCI within the previous 12 months and admitted to highly specialised rehabilitation are included, regardless of SCI aetiology or neurological level. A primary study designed as a controlled, pragmatic, preintervention- postintervention study with 6-month follow-up evaluates the effect of the clinical intervention; a prospective national cohort study on body mass index (BMI) serves as a historical control. The intervention consists of a standardised approach to patient education about cardiovascular risk factors, PA and a healthy diet that begins at the outset of primary SCI rehabilitation and is integrated into existing settings and workflows. Outcome measures are collected at admission, discharge and 6 months after discharge and include peak oxygen uptake (VO2peak) (primary outcome), BMI, body composition, metabolic profile, neurological status, level of functioning, depression, quality of life, objective PA (accelerometry), self-reported PA, self-assessed PA ability, shared decision making, and dietary habits. Test-retest reliability of four VO2peak test protocols are investigated, as is test-retest reliability of a multisensor accelerometer in a reha

Study design: Prospective quasi-experimental study, pre-and post-design. Objectives: Assess safety, feasibility, training characteristics and changes in gait function for persons with spinal cord injury (SCI) using the robotic exoskeletons from Ekso Bionics. Setting: Nine European rehabilitation centres. Methods: Robotic exoskeleton gait training, three times weekly over 8 weeks. Time upright, time walking and steps in the device (training characteristics) were recorded longitudinally. Gait and neurological function were measured by 10 Metre Walk Test (10 MWT), Timed Up and Go (TUG), Berg Balance Scale (BBS), Walking Index for Spinal Cord Injury (WISCI) II and Lower Extremity Motor Score (LEMS). Results: Fifty-two participants completed the training protocol. Median age: 35.8 years (IQR 27.5-52.5), men/women: N = 36/16, neurological level of injury: C1-L2 and severity: AIS A-D (American Spinal Injury Association Impairment Scale). Time since injury (TSI) < 1 year, N = 25; > 1 year, N = 27. No serious adverse events occurred. Three participants dropped out following ankle swelling (overuse injury). Four participants sustained a Category II pressure ulcer at contact points with the device but completed the study and skin normalized. Training characteristics increased significantly for all subgroups. The number of participants with TSI < 1 year and gait function increased from 20 to 56% (P=0.004) and 10MWT, TUG, BBS and LEMS results improved (P < 0.05). The number of participants with TSI > 1 year and gait function, increased from 41 to 44% and TUG and BBS results improved (P < 0.05). Conclusions: Exoskeleton training was generally safe and feasible in a heterogeneous sample of persons with SCI. Results indicate potential benefits on gait function and balance.

Objective: To explore changes in pain, spasticity, range of motion, activities of daily living, bowel and lower urinary tract function and quality of life of individuals with spinal cord injury following robotic exoskeleton gait training. Design: Prospective, observational, open-label multicentre study. Methods: Three training sessions per week for 8 weeks using an Ekso GT robotic exoskeleton (Ekso Bionics). Included were individuals with recent (<1 year) or chronic (>1 year) injury, paraplegia and tetraplegia, complete and incomplete injury, men and women. Results: Fifty-two participants completed the training protocol. Pain was reported by 52% of participants during the week prior to training and 17% during training, but no change occurred longitudinally. Spasticity decreased after a training session compared with before the training session (p< 0.001), but not longitudinally. Chronically injured participants increased Spinal Cord Independence Measure (SCIM III) from 73 to 74 (p= 0.008) and improved life satisfaction (p= 0.036) over 8 weeks of training. Recently injured participants increased SCIM III from 62 to 70 (p<0.001), but no significant change occurred in life satisfaction. Range of motion, bowel and lower urinary function did not change over time. Conclusion: Training seemed not to provoke new pain. Spasticity decreased after a single training session. SCIM III and quality of life increased longitudinally for subsets of participants.

INTRODUCTION: People with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective.METHODS AND ANALYSIS: Our process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome.ETHICS AND DISSEMINATION: Ethics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through public

The objectives of this article are to (1) provide an overview of existing spinal cord injury (SCI) clinical research databases-their purposes, characteristics, and accessibility to users; and (2) present a vision for future collaborations required for cross-cutting research in SCI. This vision highlights the need for validated and relevant data for longitudinal clinical trials and observational and epidemiologic SCI-related studies. Three existing SCI clinical research databases/registries are reviewed and summarized with regard to current formats, collection methods, and uses, including major strengths and weaknesses. Efforts to provide a uniform approach to data collection are also reviewed. The databases reviewed offer different approaches to capture important clinical information on SCI. They vary on size, purpose, data points, inclusion of standard outcomes, and technical requirements. Each presents with a set of limitations including lack of population data and lack of a common platform for data comparisons and exchanges. It is clear that numerous issues need to be considered when planning to establish common ways of collecting data through data sets or patient registries, ranging from a carefully crafted implementation plan that lists purposes, cost, resources required, and policies to guide such development to establishing a framework for dissemination of data and findings. For the present, taking advantage of the vast but different data already collected over many decades may require a variety of statistical skills and epidemiologic techniques. Ultimately, our ability to speak the same language with regard to variables and assessment tools will facilitate international collaborations and enhance comparability, data pooling, and the ability to generalize findings to a broader population.