Feasibility, safety, and functional outcomes using the neurological controlled Hybrid Assistive Limb exoskeleton (HAL®) following acute incomplete and complete spinal cord injury - Results of 50 patients.

OBJECTIVE: Recent studies reveal that Hybrid Assistive Limb (HAL®) locomotion training in paraplegic patients suffering from chronic spinal cord injury (SCI) induces improvements in functional and ambulatory mobility. The purpose of this study was to determine the safety, feasibility, and functional effectiveness of HAL® locomotion training in the initial rehabilitation of acute SCI patients. This clinical trial represents the first systematic intervention worldwide for acute SCI patients using a neurologically controlled exoskeleton. DESIGN: Single center, prospective study. SETTING: BG University Hospital Bergmannsheil, Bochum, Germany. PARTICIPANTS: Fifty acute SCI patients (14 women, 36 men). INTERVENTIONS: All participants received a daily (5 times/week) HAL® exoskeleton supported training for 12 weeks (mean amount of training sessions 60.4 ± 30.08). OUTCOME MEASURES: Functional outcome for overground walking was monitored using the 10-m-walk test (10 MWT) combined with the WISCI II score, 6-minute-walk test (6 MWT) and the timed-up and go test (TUG test). Treadmill-related parameters (speed, distance and walking time) and the Lower Extremity Motor Score (LEMS) were recorded separately. RESULTS: Significant improvements were observed for HAL®-associated (walking time, distance and speed) and for functional outcomes (10 MWT, 6 MWT and TUG-test). WISCI-II-Score and the LEMS increased significantly compared with the status prior to training. CONCLUSION: HAL® locomotion training is feasible and safe in the rehabilitation of acute SCI patients. The HAL® exoskeleton enables the patient to perform effective treadmill training and leads to improvements in functional and ambulatory mobility. However, spontaneous recovery vs training-related effects remain unclear and findings should not be extrapolated beyond the acute in-patient rehabilitation setting.Trial registration: German Clinical Trials Register identifier: DRKS00010250..

First experiences of communication with mechanically ventilated patients in the intensive care unit using eye-tracking technology.

INTRODUCTION: Eye-tracking (ET) may be a novel tool for communication with intubated and mechanically ventilated critically ill patients. We hypothesized that ET could be learned fast and be used successfully by intensive care unit (ICU) and intermediate care (IMC) patients with artificial airways for communication. METHODS: Including all patients with mechanical ventilation via oral intubation or tracheostomy, who were at least 18 years of age with a score of -1 to +1 points on the Richmond agitation-sedation scale and a history of ventilation for more than 48 h. A commercially available ET was used. The investigations were performed by a physician with the support of a psychologist following a standardized study protocol. RESULTS: During a 4-week period a total of 11 patients completed all of the five steps of our study protocol. The time to complete our study protocol was 64 ± 23.8 min (range 43-125 min) with a mean of 1.5 ± 0.9 sessions (range 1-4 sessions). Seven patients (63.6 %) could run through all of the five steps within their first session. All patients (100%) preferred the gaze fixation technique to control the ET to the wink control. CONCLUSION: Mechanically ventilated ICU and IMC patients are able to use ET in a very short time for communication to indicate their basic needs, answer rating scales and pain scores as well as questionnaires about quality of life and self-esteem.Implications for rehabilitationCOMFORT - The novel communication device improves the patients' ability to communicate with the attending physicians, physiotherapists and nurses in order to provide a tailored rehabilitation approach.COMPLIANCE - The use of the eye-tracking technology enables the patients to communicate special needs and fears during the course of the rehabilitation.COMPLICATIONS - The eye-tracking technology enables the attending rehabilitation team to earlier detect complications (e.g. pain, depression) during the course of the rehabilitation.

Development of the Tracheostomy Well-Being Score in critically ill patients.

PURPOSE: Little attention has been given to understanding the experiences and perceptions of tracheostomized patients. This study aimed to measure the impact of tracheostomy on well-being in critically ill patients with the development of the Tracheostomy Well-Being Score (TWBS). METHODS: This is a prospective, monocentric, observational study including critically ill patients with a tracheostomy without delirium. A 25-item questionnaire with items from six categories (respiration, coughing, pain, speaking, swallowing, and comfort) was used to select the 12 best items (two per category) to form the TWBS score after testing on two consecutive days. Item selection secured (1) that there were no skewed response distributions, (2) high stability from day 1 to day 2, and (3) high prototypicality for the category in terms of item-total correlation. RESULTS: A total of 63 patients with a mean age of 56 years were included. The 12 items of the TWBS were characterized by a high retest reliability (τ = 0.67-0.93) and acceptable internal consistency. The overlap with the clinician rating was low, suggesting that acquiring self-report data is strongly warranted. CONCLUSION: With the TWBS, an instrument is available for the assessment of the subjective effects a tracheostomy has on in critically ill patients. The score potentially offers a chance to increase well-being of these patients. Additionally, this score could also increase their quality of life by improving tracheostomy and weaning management. CLINICAL TRIAL REGISTRATION: German Clinical Trials Register Identifier DRKS00022073 (2020/06/02).

Pilot study: advanced haemodynamic monitoring after acute spinal cord injury-Keep the pressure up?

BACKGROUND: Although the use of vasopressors to maintain haemodynamic goals after acute spinal cord injury (SCI) is still recommended, evidence regarding the target values and possible risks of this practice is limited, and data on haemodynamic parameters unaffected by catecholamines are rare. In this pilot study, we show the haemodynamic profile of patients with acute SCI mainly unaffected by vasopressor use and other factors that influence the cardiovascular system. METHODS: From March 2018 to March 2020, we conducted a prospective, single-centre pilot study of 30 patients with acute SCI. Factors that could affect the cardiocirculatory system other than SCI (sepsis, pre-existing heart disease or multiple trauma) led to exclusion. A total of 417 measurements were performed using the PiCCO™ system. RESULTS: The mean systemic vascular resistance index (SVRI, 1447.23 ± 324.71 dyn*s*cm-5*m2), mean central venous pressure (CVP, 10.69 ± 3.16) and mean global end-diastolic volume index (GEDVI, 801.79 ± 158.95 ml/m2) deviated from the reference range, while the mean cardiac index (CI), mean stroke volume index (SVI), mean arterial pressure (MAP), and mean heart rate (HR) were within the reference range, as indicated in the literature. A mixed model analysis showed a significant negative relationship between norepinephrine treatment and MAP (83.97 vs. 73.69 mmHg, p < 0.001), SVRI (1463.40 vs. 1332.14 dyn*s*cm-5*m2, p = 0.001) and GEDVI (808.89 vs. 759.39 ml/m2, p = 0.001). CONCLUSION: These findings could lead to an adaptation of the target range for SVRI and MAP in patients with acute SCI and therefore reduce the use of vasopressors.

Approach to the basic needs in patients on invasive ventilation using eye-tracking devices for non-verbal communication.

PURPOSE: To analyze the feasibility of eye-tracking (ET) devices as a communicative approach to the basic needs (BN) of intensive care unit (ICU) and invasively ventilated nonverbal patients. METHODS: Prospective, monocentric, and observational study including all patients without delirium, with an endotracheal tube or tracheostomy tube, with a history of invasive ventilation for more than 48 h, and inadequate nonverbal communication skills. The investigation was performed with commercially available ET devices (Tobii Dynavox I-15+) to express BN of ICU patients following a standardized 30-item yes-or-no questionnaire. RESULTS: A total of 64 patients with a mean age of 58.6 years were included. The main diagnoses for ICU admission were major trauma (43.6%), sepsis (21.8%), and acute abdomen (15.6%). Pain during repositioning (69%), thirst (69%), sleep disorders (66%), fatigue (64%), and anxiety regarding the lifelong need for assistance (64%) were the main problems reported by the patients. However, most of the patients described expectations of health improvement (78%), good family support (66%), and an improvement in quality of life due to the use of ET devices (67%). CONCLUSION: The use of ET in selected ICU patients with impaired communication is feasible, allowing them to express their BN. Apart from knowing the patients' individual BN, the results of our BN questionnaire may provide guidance for improvement measures in the care of patients in the ICU who are unable to speak. We believe that ET is useful for inquiring about and expressing BN and, therefore, may be capable of improving patient-medical team interactions and patient satisfaction.

The use of predefined scales and scores with eye-tracking devices for symptom identification in critically ill nonverbal patients.

BACKGROUND: Eye tracking (ET) may be a novel tool to enable nonverbal communication. We hypothesized that ET could be used successfully by intensive care unit (ICU) patients with artificial airways to express their levels of pain and mood, quality of life, and self-esteem with predefined scales and scores. METHODS: Prospective, monocentric, observational study, including patients with an endotracheal tube or tracheostomy tube and a history of mechanical ventilation for more than 48 hours without delirium, and inadequate nonverbal communication skills. The ICU patients' pain was assessed with a numeric rating scale, their mood was tested with a smiley analog scale. Quality of life and self-esteem were measured with the European quality of life-5 dimensions-5 levels-score and the visual analog self-esteem scale. RESULTS: A total of 75 patients with a mean age of 58.3 years were included. Main diagnoses for ICU admission were major trauma (45.3%), nonabdominal sepsis (22.6%), and acute abdomen (13.3%). Patients showed moderate levels of pain and sadness with a median of 4 (interquartile range, 3-5.5) on the numeric rating scale and a median of 4 (interquartile range, 3-4) on the smiley analog scale. The general health status on the European quality of life-5 dimensions-5 levels-score was rated as poor. Reporting on the visual analog self-esteem scale, most of the included patients felt trapped (90.7%) and not confident (72%), were frustrated (64%) or did not feel understood (56%). However, despite their severe illness, many patients classified themselves as intelligent (30.6%), not mixed up (38.6%), outgoing (38.6%), and optimistic (44%). CONCLUSION: Eye tracking enables symptom identification in critically ill voiceless patients with impaired communication options. The results of our study may provide guidance for improvement measures in the care of voiceless ICU patients. We believe that ET is useful for symptom identification and therefore may be capable of improving patient-medical team interaction and patient satisfaction. LEVEL OF EVIDENCE: Diagnostic Test or Criteria, Level III.

Spinal Cord Injury With Tetraplegia in Young Persons After Diving Into Shallow Water: What Has Changed in the Past 10 to 15 Years?

STUDY DESIGN: Retrospective, monocentric, observational study in a tertiary health care center. OBJECTIVES: To analyze prehospital and clinical findings, complications, neurological improvement and follow-up in a young person cohort with spinal cord injury (SCI) and tetraplegia according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) A to D after diving into shallow water. METHODS: Included were all persons younger than 50 years with SCI after head-first diving into shallow water between June 2001 and June 2019. All persons with SCI were divided into complete tetraplegia (AIS A) and incomplete tetraplegia (AIS B, C, and D) to test differences. RESULTS: A total of 59 males (98.7%) and 1 female with a mean age of 27.7 years suffered an SCI. Alcohol use was documented in 25 cases (41.7%). At the time of admission, 33 people (55%) showed a complete tetraplegia (AIS A) and 27 showed an incomplete tetraplegia with 8 AIS B (13.3%), 15 AIS C (25%), and 4 AIS D (6.7%). At the time of discharge, people with initially complete tetraplegia showed a significant improvement from admission to discharge (P ≤ .004). Persons with incomplete tetraplegia were more likely to improve their neurological status compared with complete tetraplegia patients (P ≤ .001). Especially persons with complete tetraplegia suffered from typical SCI-related problems and complications. CONCLUSIONS: People with SCI and tetraplegia at the time admission show neurological improvement in 50% of the cases with an overall better outcome in persons with incomplete tetraplegia. The surgical treatment of SCI within 24 hours seems to be associated with a better neurological outcome and a lower level of tetraplegia. The incidence of SCI caused by diving into shallow water remains stable without a significant change, especially in high-risk groups. More education and prevention programs are necessary to avoid these injuries.

Risk factors and outcome of patients with periprosthetic joint infection admitted to intensive care unit.

INTRODUCTION: Prosthetic joint infection (PJI) is a severe complication after total joint replacement surgery. The current study analyzes the outcome and mortality of patients admitted to an intensive care unit following PJI. METHODS: Retrospective analysis of all patients treated between 2012 and 2016 due to PJI in the surgical intensive care unit of a university hospital. RESULTS: A total of 124 patients were included. The mean age was 75 ± 11 years. Of those 124 patients, 85 patients (68.5%) suffered a prosthetic infection of the hip, 33 patients (27.3%) of the knee, six patients (4.8%) of hip and knee. 52 patients were male (40.9%). The assessed mean Simplified Acute Physiology Score II (SAPSII) was 29.6 ± 5.9. The mortality rate was 21% (26/124). Of surviving patients, 53.1% were discharged home, 25.5% were transferred to a nursing home, and 21.4% were transferred to a geriatric rehabilitation center. Comparing survivors to non-survivors, the non-survivor group showed a higher incidence of renal replacement therapy (46.1 vs 3.0%; p < 0.01), higher SAPSII on admission (35.7 vs. 29.0; p = 0.01) and higher Charlson Comorbidity Indices (CCI) (5.5 vs. 2.82; p < 0.01). The multivariate regression identified CCI (odds ratio 1.49; p < 0.01) and renal replacement therapy (odds ratio 12.4; p < 0.01) as independent risk factors for increased mortality. CONCLUSIONS: Admission to an intensive care unit was associated with a mortality rate of 21%. Factors associated with poor outcomes included renal replacement therapy, higher admission SAPII scores, and higher admission Charlson comorbidity index. These factors could be used for individual risk assessment on admission to the ICU.

Incidence and complications of cannula changes in long-term tracheotomized patients: a prospective observational study.

STUDY DESIGN: Prospective, monocentric observational study. OBJECTIVE: Investigation of incidence and complication rate of cannula changes in long-term tracheotomized patients suffering spinal cord injury. SETTING: University hospital in Bochum, Germany. METHODS: Prospective data collection of all cannula changes between September 2016 and September 2017. Physicians recorded mechanical complications and techniques to solve them, and/or complications resulting in patient-threatening condition. RESULTS: There were 149 cannula changes during 3191 observation days. Overall, urgent cannula changes occurred 2.1 times per 100 observation days. Within the first 8 weeks after tracheostomy, urgent cannula changes were necessary four times per 100 observation days, and were mandatory less than two times per 100 observation days thereafter. Overall, mechanical complications occurred in 12% of cannula changes, and 8% of cannula changes were accompanied by patient-threatening complications. Accidental decannulation (AD) occurred in 0.97 of 100 observation days. Recannulation after AD was accompanied by 29% of mechanical complications during reinsertion, and 16% led to patient-threatening complications. The major risk factors for mechanical complications were the time lag between cannula change and tracheostomy, and the urgency of the procedure while the thyroid cartilage-jugular distance was significantly associated with patient-threatening complications. CONCLUSION: AD and the requirement for urgent cannula changes are common and often related with mechanical and patient-threatening complications. Even weeks after tracheostomy, caregivers need to be aware of serious events, and therefore provide monitoring, knowledge, and appropriate resources to handle these events.

Differences between primary and secondary definitive osteosynthesis for fractures of the lower leg with concomitant acute compartment syndrome.

PURPOSE: To analyze the differences in outcomes between primary and secondary definitive osteosynthesis for fractures of the lower leg with concomitant acute compartment syndrome (ACS). METHODS: From our trauma database, we identified a total of 107 patients with 126 fractures of AO/OTA type 41-44 and 120 ACS from January 01, 2001 to December 31, 2015 who were treated with primary or secondary definitive osteosynthesis after concomitant fasciotomy. RESULTS: Seventy-one patients with 77 fractures of AO/OTA classification type 41-44 suffering ACS received primary definitive osteosynthesis at the time of compartmental incision (POCI) and were compared to 36 patients with 49 fractures of AO/OTA type 41-44 and ACS, who received secondary definitive osteosynthesis after compartmental incision and soft tissue coverage (SOCI). Patients with POCI had a significantly shorter length of hospital stay with significantly fewer necessary surgeries to achieve definitive fracture treatment and soft tissue closure than SOCI patients (p ≤ 0.001). The overall rate of infections in both groups was 13%, without any difference between POCI and SOCI. CONCLUSIONS: POCI for AO/OTA fractures type 41-44 with ACS is a safe and effective procedure without increasing the infection rate compared to a gradual treatment (SOCI). However, the possible selection bias due to the retrospective study design needs to be considered.

Cervical Spinal Cord Injury Shows Markedly Lower than Predicted Mortality (>72 Hours After Multiple Trauma) From Sepsis and Multiple Organ Failure.

BACKGROUND: Sepsis and multiple organ failure (MOF) remain one of the main causes of death after multiple trauma. Trauma- and infection-associated immune reactions play an important role in the pathomechanism of MOF, but the exact pathways remain unknown. Spinal cord injury (SCI) may lead to an altered immune response, and some studies suggest a prognostic advantage for such patients having sepsis or multiple trauma. Yet these findings need to be evaluated in larger cohorts of trauma patients. METHODS: Retrospective, multicenter study, using the data of the TraumaRegister DGU. Patients with and without SCI surviving the initial first 72 hours after trauma were matched according to injury pattern and age. Comparative analysis considered morbidity (sepsis, MOF) and hospital mortality. RESULTS: The study population included 800 matched pairs. As intended by the matching process, patients with cervical SCI had an otherwise comparable injury pattern but a higher severity of trauma (mean Injury Severity Score: 36 vs 29, mean number of diagnosis: 5.6 vs 4.4). They had a higher rate of sepsis (15.9% vs 10.9%, P = .005) and MOF (35.9% vs 24.1%, P < .001) while mortality revealed no significant difference (9.5% vs 9.9%, P = .866). CONCLUSIONS: Cervical SCI leads to an increased rate of sepsis and MOF but appears to be favorable with respect to outcome of sepsis and MOF following multiple trauma. Further research should focus on the pathomechanisms and the possible arising therapeutic options.

Evaluating the microbial pattern of periprosthetic joint infections of the hip and knee.

PURPOSE: Periprosthetic joint infection (PJI) is a devastating complication that leads to enormous economic and health care complaints from affected patients. The aim of this study is to identify the causative pathogens responsible for PJI, evaluate temporal trends concerning the pathogen pattern and identify potential risk factors for PJI. METHODOLOGY: This was a retrospective study analysing a total of 937 patients suffering PJI of the hip or knee joint between 2003 and 2011. RESULTS: In total, 394 patients (42.0 %) with total knee arthroplasty (TKA), 477 patients (50.9 %) with total hip arthroplasty (THA) and 64 patients (6.8 %) receiving a dual-head prosthesis had to be hospitalised due to PJI. In two cases (0.2 %), a simultaneous infection of TKA and THA occurred. The mean age of the study cohort was 70.85±11.68 years. The mean body mass index (BMI) was 28.53±5.7. According to the Charlson comorbidity index, 2.99 % of the patients were classified as severity Grade 1, 13.98 % Grade 2, 40.02 % Grade 3 and 43.0 % Grade 4. Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus epidermidis (MRSE), methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative Staphylococcus (CoNS), Streptococcus, and Enterococcus were the pathogens mainly responsible. An increase in high-resistance pathogens, such as MRSE, extended-spectrum beta-lactamase bacteria (ESBL), ampicillin-resistant Enterococcus, Acinetobacter spp. and vancomycin-resistant Enterococcus (VRE), was found during the study period. Only MRSA showed a declining tendency in a regression model. CONCLUSION: Patients suffering PJI present a certain risk profile with many comorbidities, e.g. high age and obesity. The observed microbiological pattern demonstrates the rise of high-resistance pathogens.

Percutaneous Dilatational Tracheostomy in Ankylosing Spondylitis (Bechterew Disease) Is Feasible and Not Associated With Higher Complication Rates.

BACKGROUND: Ankylosing spondylitis (AS) is a common disease with an incidence of approximately 0.5% in Europe, causing severe limitations of axial spine mobility and cervical kyphosis. Deformities of the cervical spine and the temporomandibular joints could increase the risk of complications while performing an intubation or tracheostomy. The percutaneous dilatational tracheostomy (PDT) is a standard procedure in intensive care medicine. However, the combination of cervical kyphosis and osteoporosis makes patient positioning challenging. Therefore, one could conclude that patients with AS are not candidates for PDT, but neither studies nor case reports yet reported about feasibility of this procedure in AS. METHODS: Retrospective analysis at a level 1 trauma center of patient records from 2002 to 2016, assessing all patients with AS and PDT. RESULTS: A total of 31 patients with AS have been subjected to PDT. All PDTs were performed using the modified Ciaglia single-step dilatational technique. Neither cardiopulmonary nor surgical complications occurred during the procedure. One patient received a change of the existing airway prior to the procedure; a small nasal tube was changed for a laryngeal mask. CONCLUSION: Although head positioning may be challenging, PDT should be taken into consideration for patients with AS. In the hands of an experienced doctor, it is safe and feasible.

Hybrid Assistive Limb Exoskeleton HAL in the Rehabilitation of Chronic Spinal Cord Injury: Proof of Concept; the Results in 21 Patients.

INTRODUCTION: The use of mobile exoskeletons is becoming more and more common in the field of spinal cord injury (SCI) rehabilitation. The hybrid assistive limb (HAL) exoskeleton provides a tailored support depending on the patient's voluntary drive. MATERIALS AND METHODS: After a pilot study in 2014 that included 8 patients with chronic SCI, this study of 21 patients with chronic SCI serves as a proof of concept. It was conducted to provide further evidence regarding the efficacy of exoskeletal-based rehabilitation. Functional assessment included walking speed, distance, and time on a treadmill, with additional analysis of functional mobility using the following tests: 10-meter walk test (10MWT), timed up and go (TUG) test, 6-minute walk test (6MWT), and the walking index for SCI II (WISCI-II) score. RESULTS: After a training period of 90 days, all 21 patients significantly improved their functional and ambulatory mobility without the exoskeleton. Patients were assessed by the 6MWT, the TUG test, and the 10MWT, which also indicated an increase in the WISCI-II score along with significant improvements in HAL-associated walking speed, distance, and time. CONCLUSION: Although, exoskeletons are not yet an established treatment in the rehabilitation of spinal cord injuries, the devices will play a more important role in the future. The HAL exoskeleton training enables effective, body weight-supported treadmill training and is capable of improving ambulatory mobility. Future controlled studies are required to enable a comparison of the new advances in the field of SCI rehabilitation with traditional over-ground training.

Functional Outcome of Neurologic-Controlled HAL-Exoskeletal Neurorehabilitation in Chronic Spinal Cord Injury: A Pilot With One Year Treatment and Variable Treatment Frequency.

STUDY DESIGN: Longitudinal prospective study. OBJECTIVES: Whether 1-year HAL-BWSTT of chronic spinal cord injured patients can improve independent ambulated mobility further as a function of training frequency, after an initial 3-month training period. METHODS: Eight patients with chronic SCI were enrolled. They initially received full standard physical therapy and neurorehabilitation in the acute/subacute posttrauma phase. During this trial, all patients first underwent a daily (5 per week) HAL-BWSTT for 12 weeks. Subsequently, these patients performed a 40-week HAL-BWSTT with a training session frequency of either 1 or 3 to 5 sessions per week. The patients' functional status including HAL-associated treadmill-walking time, -distance, and -speed with additional analysis of gait pattern, and their independent (without wearing the robot suit) functional mobility improvements, were assessed using the 10-Meter-Walk Test (10MWT), Timed-Up-and-Go Test (TUG) and 6-Minute-Walk Test (6MinWT) on admission, at 6 weeks, 12 weeks, and 1 year after enrollment. The data were analyzed separately for the 2 training frequency subgroups after the initial 12-week training period, which was identical in both groups. RESULTS: During the 1-year follow-up, HAL-associated walking parameters and independent functional improvements were maintained in all the patients. This result held irrespective of the training frequency. CONCLUSIONS: Long-term 1-year maintenance of HAL-associated treadmill walking parameters and of improved independent walking abilities after initial 12 weeks of daily HAL-BWSTT is possible and depends mainly on the patients' ambulatory status accomplished after initial training period. Subsequent regular weekly training, but not higher frequency training, seems to be sufficient to preserve the improvements accomplished.

Extracorporeal membrane oxygenation in spina bifida and (H1N1)-induced acute respiratory distress syndrome.

Acute respiratory distress syndrome (ARDS) is characterized as an acute hypoxemic and/or hypercapnic respiratory failure seen in critically ill patients and is still, although decreased over the past few years, associated with high mortality. Furthermore, ARDS may be a life-threatening complication of H1N1 pneumonia. We report on a 45-year-old spina bifida patient with confirmed H1N1 influenza virus infection causing acute respiratory failure, who was successfully weaned from 42-day veno-venous extracorporeal membrane oxygenation (vv-ECMO) treatment with an excellent outcome. Due to the physical constitution of spina bifida patients, we experienced challenges concerning cannula positioning and mechanical ventilation settings during weaning.

Treadmill Training with HAL Exoskeleton-A Novel Approach for Symptomatic Therapy in Patients with Limb-Girdle Muscular Dystrophy-Preliminary Study.

Purpose: Exoskeletons have been developed for rehabilitation of patients with walking impairment due to neurological disorders. Recent studies have shown that the voluntary-driven exoskeleton HAL® (hybrid assistive limb) can improve walking functions in spinal cord injury and stroke. The aim of this study was to assess safety and effects on walking function of HAL® supported treadmill therapy in patients with limb-girdle muscular dystrophy (LGMD). Materials and Methods: Three LGMD patients received 8 weeks of treadmill training with HAL® 3 times a week. Outcome parameters were 10-meter walk test (10 MWT), 6-minute walk test, and timed-up-and-go test (TUG). Parameters were assessed pre and post training and 6 weeks later (follow-up). Results: All patients completed the therapy without adverse reactions and reported about improvement in endurance. Improvements in outcome parameters after 8 weeks could be demonstrated. Persisting effects were observed after 6 weeks for the 10 MWT and TUG test (follow-up). Conclusions: HAL® treadmill training in LGMD patients can be performed safely and enables an intensive highly repetitive locomotor training. All patients benefitted from this innovative method. Upcoming controlled studies with larger cohorts should prove its effects in different types of LGMD and other myopathies.

Against the odds: what to expect in rehabilitation of chronic spinal cord injury with a neurologically controlled Hybrid Assistive Limb exoskeleton. A subgroup analysis of 55 patients according to age and lesion level.

Objective Age and lesion level are believed to represent outcome predictors in rehabilitation of patients with chronic spinal cord injury (SCI). The Hybrid Assistive Limb (HAL) exoskeleton enables patients to perform a voluntary controlled gait pattern via an electromyography-triggered neuromuscular feedback system, and has been introduced as a temporary gait training tool in patients with SCI. The aim of this prospective pre- and postintervention study was to examine functional outcomes as a function of age and lesion level in patients with chronic incomplete SCI (iSCI) or chronic complete SCI (cSCI) with zones of partial preservation (ZPP) by using the HAL as a temporary training tool. Methods Fifty-five participants with chronic iSCI or cSCI (mean time since injury 6.85 ± 5.12 years) were classified according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) and divided by age (< 50 or ≥ 50 years), independent of lesion level, and also into 4 homogeneous groups according to lesion level. The subgroups were as follows: Subgroup 1, tetraplegic iSCI (n = 13) (C2-8, AIS C [n = 8] and AIS D [n = 5]); Subgroup 2, paraplegic iSCI with spastic motor behavior (n = 15) (T2-12, AIS C [n = 8] and AIS D [n = 7]); Subgroup 3, paraplegic cSCI with complete motor paraplegia and absence of spastic motor behavior (n = 18) (T11-L4 [AIS A], and ZPP from L-3 to S-1); and Subgroup 4, paraplegic iSCI with absence of spastic motor behavior (n = 9) (T12-L3, AIS C [n = 8] and AIS D [n = 1]). The training paradigm consisted of 12 weeks of HAL-assisted treadmill training (5 times/week). Baseline status was documented prior to intervention by using the AIS grade, Walking Index for SCI II (WISCI II) score, the 10-meter walk test (10MWT), and the 6-minute walk test (6MinWT). Training effects were assessed after 6 and 12 weeks of therapy, without HAL assistance. Results Overall, a time reduction of 47% in the 10MWT, self-selected speed (10MWTsss) (< 50 years = 56% vs ≥ 50 years = 37%) and an increase of 50% in the 6MinWT were documented. The WISCI II scores showed a mean gain of 1.69 levels. At the end of the study, 24 of 55 patients (43.6%) were less dependent on walking aids. Age had a nonsignificant negative influence on the 10MWTsss. Despite a few nonsignificant subgroup differences, participants improved across all tests. Namely, patients with iSCI who had spastic motor behavior improved to a nonsignificant, lesser extent in the 6MinWT. Conclusions The HAL-assisted treadmill training leads to functional improvements in chronic iSCI or cSCI, both in and out of the exoskeleton. An improvement of approximately 50% in the 10MWTsss and in gait endurance (6MinWT) can be expected from such training. The influences of SCI lesion level and age on functional outcome were nonsignificant in the present study. Older age (≥ 50 years) may be associated with smaller improvements in the 10MWTsss. An iSCI in paraplegic patients with spastic motor behavior may be a nonsignificant negative predictor in gait endurance improvements. Clinical trial registration no.: DRKS00010250 ( https://drks-neu.uniklinik-freiburg.de/drks_web/setLocale_DE.do ).

The Effectiveness and Safety of Exoskeletons as Assistive and Rehabilitation Devices in the Treatment of Neurologic Gait Disorders in Patients with Spinal Cord Injury: A Systematic Review.

Study Design Systematic review. Clinical Questions (1) When used as an assistive device, do wearable exoskeletons improve lower extremity function or gait compared with knee-ankle-foot orthoses (KAFOs) in patients with complete or incomplete spinal cord injury? (2) When used as a rehabilitation device, do wearable exoskeletons improve lower extremity function or gait compared with other rehabilitation strategies in patients with complete or incomplete spinal cord injury? (3) When used as an assistive or rehabilitation device, are wearable exoskeletons safe compared with KAFO for assistance or other rehabilitation strategies for rehabilitation in patients with complete or incomplete spinal cord injury? Methods PubMed, Cochrane, and Embase databases and reference lists of key articles were searched from database inception to May 2, 2016, to identify studies evaluating the effectiveness of wearable exoskeletons used as assistive or rehabilitative devices in patients with incomplete or complete spinal cord injury. Results No comparison studies were found evaluating exoskeletons as an assistive device. Nine comparison studies (11 publications) evaluated the use of exoskeletons as a rehabilitative device. The 10-meter walk test velocity and Spinal Cord Independence Measure scores showed no difference in change from baseline among patients undergoing exoskeleton training compared with various comparator therapies. The remaining primary outcome measures of 6-minute walk test distance and Walking Index for Spinal Cord Injury I and II and Functional Independence Measure-Locomotor scores showed mixed results, with some studies indicating no difference in change from baseline between exoskeleton training and comparator therapies, some indicating benefit of exoskeleton over comparator therapies, and some indicating benefit of comparator therapies over exoskeleton. Conclusion There is no data to compare locomotion assistance with exoskeleton versus conventional KAFOs. There is no consistent benefit from rehabilitation using an exoskeleton versus a variety of conventional methods in patients with chronic spinal cord injury. Trials comparing later-generation exoskeletons are needed.

Optical control of hard X-ray polarization by electron injection in a laser wakefield accelerator.

Laser-plasma particle accelerators could provide more compact sources of high-energy radiation than conventional accelerators. Moreover, because they deliver radiation in femtosecond pulses, they could improve the time resolution of X-ray absorption techniques. Here we show that we can measure and control the polarization of ultra-short, broad-band keV photon pulses emitted from a laser-plasma-based betatron source. The electron trajectories and hence the polarization of the emitted X-rays are experimentally controlled by the pulse-front tilt of the driving laser pulses. Particle-in-cell simulations show that an asymmetric plasma wave can be driven by a tilted pulse front and a non-symmetric intensity distribution of the focal spot. Both lead to a notable off-axis electron injection followed by collective electron-betatron oscillations. We expect that our method for an all-optical steering is not only useful for plasma-based X-ray sources but also has significance for future laser-based particle accelerators.