Outcome, predictors and longitudinal trajectories of subjects with critical illness polyneuropathy and myopathy (CINAMOPS): study protocol of an observational cohort study in a clinical and post-clinical setting.

INTRODUCTION: Critical illness polyneuropathy and myopathy (CIP/CIM) are frequent complications in the intensive care unit (ICU) with major consequences for the progress and outcome of subjects. CIP/CIM delays the weaning process, prolongs the hospital stay and increases the mortality rate. Additionally, it may have long-term consequences beyond the hospitalisation phase with prolonged disability. Even though there is growing interest in CIP/CIM, research about the clinical and post-clinical course as well as the middle-term and long-term outcomes of subjects with CIP/CIM is scarce. A large prospective study of critically ill subjects is needed with accurate diagnosis during the acute stage and comprehensive assessment during long-term follow-up. METHODS AND ANALYSIS: This prospective observational cohort study aims to compare the clinical and post-clinical course of chronically critically ill subjects with and without the diagnosis of CIP/CIM and to determine predictors for the middle-term and long-term outcomes of subjects with CIP/CIM. In addition, the influence of the preclinical health status and the preclinical frailty on the long-term outcome of subjects with CIP/CIM will be investigated.This single-centre study will include 250 critically ill patients who were invasively ventilated for at least 5 days at the ICU and show reduced motor strength. At five study visits at admission and discharge to neurological rehabilitation, and 12, 18 and 24 months after disease onset, a comprehensive test battery will be applied including assessments of functioning and impairment, independence, health-related quality of life, activity and participation, cognition, gait and balance, fatigue, mental health and frailty.Secondary objectives are the documentation of therapy goals, therapy content and achieved milestones during the rehabilitation, to evaluate the clinimetric properties of the Mini-BESTest in critically ill patients, and to evaluate the time course and outcome of subjects with CIP/CIM after SARS-CoV-2 infection. ETHICS AND DISSEMINATION: The study was approved by the ethical committee of the Ludwig-Maximilians University Munich. Participants will be included in the study after having signed informed consent.Results will be published in scientific, peer-reviewed journals and at national and international conferences. TRIAL REGISTRATION NUMBER: German Clinical Trial Register (DRKS00021753).

Reduced health-related quality of life, fatigue, anxiety and depression affect COVID-19 patients in the long-term after chronic critical illness.

The term chronic critical illness describes patients suffering from persistent organ dysfunction and prolonged mechanical ventilation. In severe cases, COVID-19 led to chronic critical illness. As this population was hardly investigated, we evaluated the health-related quality of life, physical, and mental health of chronically critically ill COVID-19 patients. In this prospective cohort study, measurements were conducted on admission to and at discharge from inpatient neurorehabilitation and 3, 6, and 12 months after discharge. We included 97 patients (61 ± 12 years, 31% women) with chronic critical illness; all patients required mechanical ventilation. The median duration of ICU-treatment was 52 (interquartile range 36-71) days, the median duration of mechanical ventilation was 39 (22-55) days. Prevalences of fatigue, anxiety, and depression increased over time, especially between discharge and 3 months post-discharge and remained high until 12 months post-discharge. Accordingly, health-related quality of life was limited without noteworthy improvement (EQ-5D-5L: 0.63 ± 0.33). Overall, the burden of symptoms was high, even one year after discharge (fatigue 55%, anxiety 42%, depression 40%, problems with usual activities 77%, pain/discomfort 84%). Therefore, patients with chronic critical illness should receive attention regarding treatment after discharge with a special focus on mental well-being.Trial registration: German Clinical Trials Register, DRKS00025606. Registered 21 June 2021-Retrospectively registered, https://drks.de/search/de/trial/DRKS00025606 .

Monitoring Active Patient Participation During Robotic Rehabilitation: Comparison Between a Robot-Based Metric and an EMG-Based Metric.

While rehabilitation robots present a much-needed solution to improving early mobilization therapy in demanding clinical settings, they also present new challenges and opportunities in patient monitoring. Aside from the fundamental challenge of quantifying a patient's voluntary contribution during robot-led therapy motion, many sensors cannot be used in clinical settings due to time and space limitations. In this paper, we present and compare two metrics for monitoring a patient's active participation in the motion. The two metrics, each derived from first principles, have the same biomechanical interpretability, i.e., active work by the patient during the robotic mobilization therapy, but are calculated in two different spaces (Cartesian vs. muscle space). Furthermore, the sensors used to quantify these two metrics are fully independent from each other and the associated measurements are unrelated. Specifically, the robot-based work metric utilizes robot-integrated force sensors, while the EMG-based work metric requires electrophysiological sensors. We then apply the two metrics to therapy performed using a clinically certified, commercially available robotic system and compare them against the specific instructions given to the healthy subjects as well as against each other. Both metric outputs qualitatively match the expected behavior of the healthy subjects. Additionally, strong correlations (median [Formula: see text]) are shown between the two metrics, not only for healthy subjects (n = 12) but also for patients (n = 2), providing solid evidence for their validity and translatability. Importantly, the robot-based work metric does not rely on any sensors outside of those integrated into the robot, thus making it ideal for application in clinical settings.

Severe Post-COVID-19 Condition after Mild Infection: Physical and Mental Health Eight Months Post Infection: A Cross-Sectional Study.

Severe acute COVID-19 infections requiring intensive care treatment are reported risk factors for the development of post-COVID-19 conditions. However, there are also individuals suffering from post-COVID-19 symptoms after mild infections. Therefore, we aimed to describe and compare the health status of patients who were initially not hospitalized and patients after critical illness due to COVID-19. The outcome measures included health-related quality of life (EQ-5D-5L, visual analogue scale (VAS)); mental health (hospital anxiety and depression scale (HADS)); general disability (WHODAS-12); and fatigue (Fatigue-Severity-Scale-7). Individuals were recruited at Schoen Clinic Bad Aibling, Germany. A total of 52 non-hospitalized individuals (47 ± 15 years, 64% female, median 214 days post-infection) and 75 hospitalized individuals (61 ± 12 years, 29% female, 235 days post-infection) were analyzed. The non-hospitalized individuals had more fatigue (87%) and anxiety (69%) and a decreased health-related quality of life (VAS 47 ± 20) compared to the hospitalized persons (fatigue 45%, anxiety 43%, VAS 57 ± 21; p < 0.010). Severe disability was observed in one third of each group. A decreased quality of life and disability were more pronounced in the females of both groups. After adjusting for confounding, hospitalization did not predict the burden of symptoms. This indicates that persons with post-COVID-19 conditions require follow-up services and treatments, independent of the severity of the acute infection.

Critical COVID-19 disease: Clinical course and rehabilitation of neurological deficits.

Background: The COVID-19 disease frequently causes neurological symptoms. Critically ill patients often require neurorehabilitation for manifestations like intensive care unit (ICU) acquired weakness or encephalopathy. The outcome of these patients, however, is largely unknown. Here we report the clinical course of critical affected COVID-19 patients from hospital admission to discharge from inpatient neurorehabilitation. Methods: Prospective cohort study. COVID-19 patients admitted to neurorehabilitation were included based on a laboratory-confirmed SARS-CoV-2 infection. Assessments [modified Rankin Scale (mRS), Barthel-Index, Fatigue-Severity-Scale-7 and health-related quality of life (EQ-5D-5L)] were conducted at admission and before discharge from inpatient care. Data were compared to the preclinical health status. Results: Sixty-one patients (62 ± 13 years, 16 female) were included in the analysis. Most patients had been treated on ICU (n = 58; 57 ± 23 days) and had received invasive ventilation (n = 57; 46 ± 21 days). After discharge from ICU, patients spent on average 57 ± 26 days in neurorehabilitation. The most frequent neurological diagnoses were ICU-acquired weakness (n = 56) and encephalopathy (n = 23). During rehabilitation overall disability improved [mRS median (IQR) 4.0 (1.0) at inclusion and 2.0 (1.0) at discharge]. However, the preclinical health state [mRS 0.0 (0.0)] was not regained (p < 0.001). This was also reflected by the Barthel-Index [preclinical 100.0 (0.0), at inclusion 42.5 (35.0), at discharge 65.0 (7.5); p < 0.001]. Patients had only minor fatigue during inpatient care. Quality of life generally improved but was still low at discharge from hospital. Conclusion: Patients with neurological sequelae after critical COVID-19 disease showed substantial deficits at discharge from inpatient care up to 4 months after the initial infection. They were restricted in activities of daily living and had reduced health-related quality of life. All patients needed continued medical support and physical treatment.

Testing robot-based assist-as-needed therapy for improving active participation of a patient during early neurorehabilitation: a case study.

In this study, a patient in the Intensive Care-Unit received robot-based mobilization therapy with an assist-as-needed (AAN) function over the course of three weeks. Therapists were able to adapt the hip range of motion $\beta$, the bed verticalization angle $\alpha$ and the leg load force FLoad for each therapy, based on the current condition of the patient. To evaluate the patient active participation, surface electromyography (sEMG) of the M. rectus femoris (RF) and M. biceps femoris (BF) were measured and analyzed. It was observed that the patient active participation, measured through sEMG, increased along with increased hip range of motion $\beta$, bed verticalization angle $\alpha$ and leg load force FLoad set by the therapists. The patient muscle activation pattern followed the pattern of healthy controls, in part. To the authors' best knowledge, this study is the first of its kind to be performed with an ICU patient.

The German version of the Stroke Upper Limb Capacity Scale: Translation, cross-cultural adaption and evaluation of its psychometric properties.

OBJECTIVE: To investigate the psychometric properties of a newly developed German version of the Stroke Upper Limb Capacity Scale (SULCS). DESIGN: Prospective cohort study. SETTING: Neurorehabilitation clinic. SUBJECTS: Patients after stroke (n = 50) with moderate to severe upper limb hemiparesis undergoing inpatient rehabilitation. INTERVENTION: Not applicable. MAIN MEASURES: The SULCS was administered twice by two different raters on the first day of assessments and another time the day after. Additionally the Fugl-Meyer-Assessment, Action Research Arm Test and the Box and Block Test were conducted. Three and six weeks later, the SULCS, Fugl-Meyer-Assessment and Box and Block Test were repeated. Floor and ceiling effects were analyzed. RESULTS: Reliability was demonstrated to be excellent as displayed by weighted kappa of 0.960 (95%-confidence interval: CIκw = 0.808-1.112) for the intra-rater reliability and 0.936 (CIκw = 0.749-1.123) for the inter-rater reliability. High correlations of the SULCS with the Fugl-Meyer-Assessment (ρ = 0.889), Action Research Arm Test (ρ = 0.872), and Box and Block Test (ρ = 0.845; all P < 0.001) confirmed a high convergent validity. The longitudinal validity was determined by a moderate to high correlation of the SULCS and Box and Block Test changes (ρ ⩾ 0.695, P ⩽ 0.001). Although floor effects were observed for the SULCS (16%), they were more substantial for the Action Research Arm Test and the Box and Block Test (>38%). CONCLUSION: Due to the good to excellent psychometric properties and the low level of floor effects of the German version of the SULCS, the usage for clinical and scientific purposes can be recommended.