Predicting and coding sound into action translation in spinal cord injured people.

Motor activation in response to perception of action-related stimuli may depend on a resonance mechanism subserving action understanding. The extent to which this mechanism is innate or learned from sensorimotor experience is still unclear. Here, we recorded EEG while people with paraplegia or tetraplegia consequent to spinal cord injury (SCI) and healthy control participants were presented with action sounds produced by body parts (mouth, hands or feet) that were or were not affected by SCI. Non-action sounds were used as further control. We observed reduced brain activation in subjects affected by SCI at both pre- and post-stimulus latencies specifically for those actions whose effector was disconnected by the spinal lesion (i.e., hand sound for tetraplegia and leg sound for both paraplegia and tetraplegia). Correlation analyses showed that these modulations were functionally linked with the chronicity of the lesion, indicating that the longer the time the lesion- EEG data acquisition interval and/or the more the lesion occurred at a young age, the weaker was the cortical activity in response to these action sounds. Tellingly, source estimations confirmed that these modulations originated from a deficit in the motor resonance mechanism, by showing diminished activity in premotor (during prediction and perception) and near the primary motor (during perception) areas. Such dissociation along the cortical hierarchy is consistent with both previous reports in healthy subjects and with hierarchical predictive coding accounts. Overall, these data expand on the notion that sensorimotor experience maintains the cortical representations relevant to anticipate and perceive action-related stimuli.

A therapist-administered self-report version of the Walking Index for Spinal Cord Injury II (WISCI): a psychometric study.

OBJECTIVE: To develop a self-report version of the Walking Index for Spinal Cord Injury II (WISCI II) and to test its reliability and validity. STUDY DESIGN: Psychometric study. SETTING: Spinal cord injury (SCI) rehabilitation centres in Australia and Italy. PARTICIPANTS: Eighty people with SCI were recruited from a sample of convenience. METHODS: Two self-report versions of the WISCI II were developed. Both versions were administered in English at the Australian site, and in Italian at the Italian site through an online platform. The format of the first self-report version (SR-V1) was similar to the original face-to-face WISCI II. The second self-report version (SR-V2) had more questions, but each question required participants to focus on one aspect of walking at a time. Participants completed SR-V1 and SR-V2 with assistance from research physiotherapists on two separate occasions, three to seven days apart. The original WISCI II was then administered through a face-to-face assessment by an independent physiotherapist. The intra-rater reliability and validity of SR-V1 and SR-V2 were determined with intraclass correlation coefficients (ICC) and percent close agreements. RESULTS: The data from the Australian and Italian sites were pooled. The validity and reliability of the two self-report versions were very similar, with SR-V2 performing slightly better than SR-V1. The ICC (95% confidence interval) of SR-V2 was 0.87 (0.81-0.92). The ICC reflecting the agreement between the self-report and the face-to-face WISCI was 0.89 (0.84-0.93). CONCLUSION: Both versions of the self-report WISCI II provide a reasonable substitute for a face-to-face assessment although therapists preferred SR-V2.

Biobanking, digital health and privacy: the choices of 1410 volunteers and neurological patients regarding limitations on use of data and biological samples, return of results and sharing.

BACKGROUND: The growing diffusion of artificial intelligence, data science and digital health has highlighted the role of collection of data and biological samples, thus raising legal and ethical concerns regarding its use and dissemination. Further, the expansion of biobanking, from the basic collection of frozen specimens to the virtual biobanks of specimens and associated data that exist today, has given a revolutionary potential on healthcare systems, particularly in the field of neurological diseases, due to the inaccessibility of central nervous system and the need of non-invasive investigation approaches. Informed Consent (IC) is considered mandatory in all research studies and specimen collections, and must specifically take into account the ethical respect to the individuals to whom the used biological material and data belong. METHODS: We evaluated the attitudes of patients with neurological diseases (NP) and healthy volunteers (HV) towards the donation of biological samples to a biobank for future research studies on neurological diseases, and limitations on the use of data, related to the requirements set by the General Data Protection Regulation (GDPR). The study involved a total of 1454 subjects, including 502 HVs and 952 NPs, recruited at Santa Lucia Foundation IRCCS, Rome, from 2020 to 2024. RESULTS: We found that (i) almost all subjects agreed with the participation in biobanking (ii) and authorization to genetic studies (HV = 99.1%; NP = 98.3%); Regarding the return of results, (iii) we found a statistically significant difference between NP and HV, the latter preferring not to be informed of potential results (HV = 43%; NP = 11.3%; p < 0.0001); (iv) a small number limited the sharing inside European Union (EU) (HV = 4.6%; NP = 6.6%), whereas patients were more likely to refuse transfer outside EU (HV = 7.4%; NP = 10.7% p = 0.05); (v) nearly all patients agreed with the use of additional health data from EMR for research purposes (98.9%). CONCLUSIONS: Consent for the donation of material for research purposes is crucial for biobanking and biomedical research studies that use biological material of human origin. Here, we have shown that choices regarding participation in a neurological biobank can be different between HVs and NPs, even if the benefit for research and scientific progress is recognized. NP have a strong interest in being informed of possible results but limit sharing of samples, highlighting a perception of greater individual or relative benefit, while HV prefer a wide dissemination and sharing of data but not to have the return of the results, favoring a possible benefit for society and knowledge. The results underline the need to carefully manage biological material and data collected in biobanks, in compliance with the GDPR and the specific requests of donors.

DiSCIoser: unlocking recovery potential of arm sensorimotor functions after spinal cord injury by promoting activity-dependent brain plasticity by means of brain-computer interface technology: a randomized controlled trial to test efficacy.

BACKGROUND: Traumatic cervical spinal cord injury (SCI) results in reduced sensorimotor abilities that strongly impact on the achievement of daily living activities involving hand/arm function. Among several technology-based rehabilitative approaches, Brain-Computer Interfaces (BCIs) which enable the modulation of electroencephalographic sensorimotor rhythms, are promising tools to promote the recovery of hand function after SCI. The "DiSCIoser" study proposes a BCI-supported motor imagery (MI) training to engage the sensorimotor system and thus facilitate the neuroplasticity to eventually optimize upper limb sensorimotor functional recovery in patients with SCI during the subacute phase, at the peak of brain and spinal plasticity. To this purpose, we have designed a BCI system fully compatible with a clinical setting whose efficacy in improving hand sensorimotor function outcomes in patients with traumatic cervical SCI will be assessed and compared to the hand MI training not supported by BCI. METHODS: This randomized controlled trial will include 30 participants with traumatic cervical SCI in the subacute phase randomly assigned to 2 intervention groups: the BCI-assisted hand MI training and the hand MI training not supported by BCI. Both interventions are delivered (3 weekly sessions; 12 weeks) as add-on to standard rehabilitation care. A multidimensional assessment will be performed at: randomization/pre-intervention and post-intervention. Primary outcome measure is the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory sub-score. Secondary outcome measures include the motor and functional scores of the GRASSP and other clinical, neuropsychological, neurophysiological and neuroimaging measures. DISCUSSION: We expect the BCI-based intervention to promote meaningful cortical sensorimotor plasticity and eventually maximize recovery of arm functions in traumatic cervical subacute SCI. This study will generate a body of knowledge that is fundamental to drive optimization of BCI application in SCI as a top-down therapeutic intervention, thus beyond the canonical use of BCI as assistive tool. TRIAL REGISTRATION: Name of registry: DiSCIoser: improving arm sensorimotor functions after spinal cord injury via brain-computer interface training (DiSCIoser). TRIAL REGISTRATION NUMBER: NCT05637775; registration date on the ClinicalTrial.gov platform: 05-12-2022.

Early and intensive motor training to enhance neurological recovery in people with spinal cord injury: trial protocol.

STUDY DESIGN: Protocol for a multi-centre randomised controlled trial (the SCI-MT trial). OBJECTIVES: To determine whether 10 weeks of intensive motor training enhances neurological recovery in people with recent spinal cord injury (SCI). SETTING: Fifteen spinal injury units in Australia, Scotland, England, Italy, Netherlands, Norway, and Belgium. METHODS: A pragmatic randomised controlled trial will be undertaken. Two hundred and twenty people with recent SCI (onset in the preceding 10 weeks, American Spinal Injuries Association Impairment Scale (AIS) A lesion with motor function more than three levels below the motor level on one or both sides, or an AIS C or D lesion) will be randomised to receive either usual care plus intensive motor training (12 h of motor training per week for 10 weeks) or usual care alone. The primary outcome is neurological recovery at 10 weeks, measured with the Total Motor Score from the International Standards for Neurological Classification of SCI. Secondary outcomes include global measures of motor function, ability to walk, quality of life, participants' perceptions about ability to perform self-selected goals, length of hospital stay and participants' impressions of therapeutic benefit at 10 weeks and 6 months. A cost-effectiveness study and process evaluation will be run alongside the trial. The first participant was randomised in June 2021 and the trial is due for completion in 2025. CONCLUSIONS: The findings of the SCI-MT Trial will guide recommendations about the type and dose of inpatient therapy that optimises neurological recovery in people with SCI. TRIAL REGISTRATION: ACTRN12621000091808 (1.2.2021).

An international survey of the structure and process of care for traumatic spinal cord injury in acute and rehabilitation facilities: lessons learned from a pilot study.

BACKGROUND: To describe the key findings and lessons learned from an international pilot study that surveyed spinal cord injury programs in acute and rehabilitation facilities to understand the status of spinal cord injury care. METHODS: An online survey with two questionnaires, a 74-item for acute care and a 51-item for rehabilitation, was used. A subset of survey items relevant to the themes of specialized care, timeliness, patient-centeredness, and evidence-based care were operationalized as structure or process indicators. Percentages of facilities reporting the structure or process to be present, and percentages of indicators met by each facility were calculated and reported separately for facilities from high-income countries (HIC) and from low and middle-income countries (LMIC) to identify "hard to meet" indicators defined as those met by less than two-thirds of facilities and to describe performance level. RESULTS: A total of 26 acute and 26 rehabilitation facilities from 25 countries participated in the study. The comparison of the facilities based on the country income level revealed three general observations: 1) some indicators were met equally well by both HIC and LMIC, such as 24-hour access to CT scanners in acute care and out-patient services at rehabilitation facilities; 2) some indicators were hard to meet for LMIC but not for HIC, such as having a multidisciplinary team for both acute and rehabilitation settings; and 3) some indicators were hard to meet by both HIC and LMIC, including having peer counselling programs. Variability was also observed for the same indicator between acute and rehabilitation facilities, and a wide range in the total number of indicators met among HIC facilities (acute 59-100%; rehabilitation 36-100%) and among LMIC facilities (acute: 41-82%; rehabilitation: 36-93%) was reported. CONCLUSIONS: Results from this international pilot study found that the participating acute and rehabilitation facilities on average adhered to 74% of the selected indicators, suggesting that the structure and processes to provide ideal traumatic spinal cord injury care were broadly available. Recruiting a representative sample of SCI facilities and incorporating regional attributes in future surveys will be helpful to examine factors affecting adherence to indicators.

Reliability and validity of the international standards for neurological classification of spinal cord injury in patients with non-traumatic spinal cord lesions.

STUDY DESIGN: Prospective, observational study. OBJECTIVES: The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) represent the gold standard for the assessment of patients with spinal cord injury (SCI) and their measurement properties have been evaluated in patients with traumatic lesions. Albeit the ISNCSCI are widely used also for the assessment and prognosis of patients with non-traumatic SCI, a validation of this grading system in this sample has never been performed. Therefore, the aim of this study is to evaluate the measurement properties of the ISNCSCI in a population of persons with non-traumatic SCI. SETTING: Three Italian rehabilitation hospitals. METHODS: The sample included 140 patients with non-traumatic SCI of different etiology, level and grade, for a total of 169 evaluations performed by two examiners. Cronbach's Alpha was used to evaluate the internal consistency of the ISNCSCI various components. The agreement between two examiners of each center in the definition of different components was used to assess the inter-rater reliability. The construct validity was evaluated through the correlation of the ISNCSCI with the Spinal Cord Independence Measure (SCIM). RESULTS: The ISNCSCI showed substantial internal consistency, and substantial inter-rater agreement for AIS grade, cumulative motor and sensory scores. The motor scores for upper and lower extremity showed fair to moderate correlation with SCIM self-care and motility subscores, respectively. The ISNCSCI total motor score correlated with the total SCIM score. CONCLUSIONS: Our study demonstrates that the ISNCSCI are a valid and reliable tool for the assessment of patients with non-traumatic SCI.

Overground robotic training effects on walking and secondary health conditions in individuals with spinal cord injury: systematic review.

Overground powered lower limb exoskeletons (EXOs) have proven to be valid devices in gait rehabilitation in individuals with spinal cord injury (SCI). Although several articles have reported the effects of EXOs in these individuals, the few reviews available focused on specific domains, mainly walking. The aim of this systematic review is to provide a general overview of the effects of commercial EXOs (i.e. not EXOs used in military and industry applications) for medical purposes in individuals with SCI. This systematic review was conducted following the PRISMA guidelines and it referred to MED-LINE, EMBASE, SCOPUS, Web of Science and Cochrane library databases. The studies included were Randomized Clinical Trials (RCTs) and non-RCT based on EXOs intervention on individuals with SCI. Out of 1296 studies screened, 41 met inclusion criteria. Among all the EXO studies, the Ekso device was the most discussed, followed by ReWalk, Indego, HAL and Rex devices. Since 14 different domains were considered, the outcome measures were heterogeneous. The most investigated domain was walking, followed by cardiorespiratory/metabolic responses, spasticity, balance, quality of life, human-robot interaction, robot data, bowel functionality, strength, daily living activity, neurophysiology, sensory function, bladder functionality and body composition/bone density domains. There were no reports of negative effects due to EXOs trainings and most of the significant positive effects were noted in the walking domain for Ekso, ReWalk, HAL and Indego devices. Ekso studies reported significant effects due to training in almost all domains, while this was not the case with the Rex device. Not a single study carried out on sensory functions or bladder functionality reached significance for any EXO. It is not possible to draw general conclusions about the effects of EXOs usage due to the lack of high-quality studies as addressed by the Downs and Black tool, the heterogeneity of the outcome measures, of the protocols and of the SCI epidemiological/neurological features. However, the strengths and weaknesses of EXOs are starting to be defined, even considering the different types of adverse events that EXO training brought about. EXO training showed to bring significant improvements over time, but whether its effectiveness is greater or less than conventional therapy or other treatments is still mostly unknown. High-quality RCTs are necessary to better define the pros and cons of the EXOs available today. Studies of this kind could help clinicians to better choose the appropriate training for individuals with SCI.

Is caregiver quality of life predicted by their perceived burden? A cross-sectional study of family caregivers of people with spinal cord injuries.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: To identify predictors of quality of life (QoL) among family caregivers of people with spinal cord injuries (SCI), considering caregiver and care recipient characteristics, and to evaluate the predictive value of caregiver burden (CB) on the QoL of family caregivers. SETTING: Multicenter study in four spinal units across Italy. METHODS: Secondary analysis of the data obtained during the validation of the Italian version of the Caregiver Burden Inventory in Spinal Cord Injuries (CBI-SCI) questionnaire. In all, 176 family caregivers completed a socio-demographic questionnaire, the Short Form-36, the CBI-SCI, and the Modified Barthel Index. A first linear regression analysis was performed to identify independent predictors of each domain of caregiver QoL. A second linear regression analysis including CBI-SCI was then performed to evaluate the predictive value of CB on caregiver QoL. RESULTS: Participants reported reduced physical and mental QoL. Significant predictors of lower scores in physical dimensions of QoL were older age and female gender. Contextual factors following SCI, such as economic difficulties and the presence of a formal caregiver, significantly predicted emotional QoL in family caregivers. Identified predictors explained 13-32% of variance. CB was a significant predictor (p < 0.001) when added to all proposed models, increasing the explained variance from 7 to 26%. CONCLUSION: Neither the clinical characteristics of, nor the relationship with care recipients predicted a worse caregiver QoL, whereas the CB did. The CB was a strong predictor of QoL among family caregivers and should be kept to a minimum to promote caregiver well-being.

Self-care in spinal cord injuries inventory (SC-SCII) and self-care self-efficacy scale in spinal cord injuries (SCSES-SCI): development and psychometric properties.

STUDY DESIGN: Validation cross-sectional study. OBJECTIVES: To develop and assess the psychometric properties of two instruments based on the middle-range theory of self-care in chronic illness: the Self-Care in Spinal Cord Injuries Inventory (SC-SCII) and the Self-Care Self-Efficacy Scale in Spinal Cord Injuries (SCSES-SCI). SETTING: Multicenter study in five spinal units across Italy and Ireland. METHODS: Instrument development was based on self-care behaviours identified in the scientific literature. Behaviours were grouped into four dimensions during a consensus conference: self-care maintenance, self-care monitoring, self-care management and self-care self-efficacy. Sixty-seven items were subsequently generated based on these dimensions. A multidisciplinary group of 40 experts evaluated content validity. Dimensionality of the final items was tested by confirmatory factor analyses (CFA) with a sample of 318 participants. Internal consistency and test-retest reliability were evaluated for each dimension. Construct validity was assessed using correlations between items and scoring differences amongst participants with more severe conditions and secondary complications. RESULTS: Content validity of the SC-SCII and SCSES-SCI was satisfactory for thirty-five of the previously generated items, which were further refined. CFA showed comparative fit indexes ranging from 0.94 to 0.97 and root mean square errors of approximation from 0.03 to 0.07. Internal consistency ranged from 0.71 to 0.85, and intraclass correlation coefficients were higher than 0.70. Correlations among dimensions were moderate, and the theoretical hypotheses formulated when designing the instruments were largely confirmed. CONCLUSIONS: The SC-SCII and the SCSES-SCI represent valid and reliable theoretically-grounded instruments to assess self-care in people with spinal cord injury.

Impact of complications at admission to rehabilitation on the functional status of patients with spinal cord lesion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Aim of the study is to evaluate the impact of complications at admission on the functional status of spinal cord lesions patients. SETTING: Rehabilitation hospital in Italy. METHODS: Two hundred and seven patients with complications (mostly pressure ulcers) at admission to rehabilitation were matched for neurological level of injury and AIS grade with 207 patients without complications. MEASURES: International Standards for Neurological Classification of Spinal Cord Injury, Spinal Cord Independence Measure, Rivermead Mobility Index, and Walking Index for Spinal Cord Injury. These measures were recorded at admission to rehabilitation and at discharge. We also recorded length of acute and rehabilitation stay and discharge destination. STATISTICS: Student's T test for paired samples, McNemar's chi-square test. RESULTS: Patients with complications at admission suffered more often from a traumatic lesions. The functional status at admission and discharge of the patients without complications was significantly better than the functional status of patients with complications (Spinal Cord Independence Measure mean difference between the two groups 5.7 (CI 2.8-8.5) at admission, and 10 (CI 5.3-14.7) at discharge). Length of stay was significantly higher in patients with complications. Patients with complications were more often institutionalized than their counterparts (46/161 vs. 20/187, odds ratio 0.4 (CI 0.2-0.7)). CONCLUSIONS: Complications seem to be more frequent in patients with traumatic lesions. The presence of complications has a negative effect on patients' functional status at discharge and length of stay, and it determines a higher risk of being institutionalized.

Comparison of outcomes between people with and without central cord syndrome.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: Central cord syndrome (CCS) is reported to have better outcomes than other cervical lesions, especially for ambulation and bladder recovery. However, a formal comparison between patients with CCS and other incomplete cervical spinal cord injuries (iCSCI) is lacking. Aim of the study is to investigate the neurological and functional outcomes in patients with or without CCS. SETTING: European Multicenter Study. METHODS: Data following SCI were derived from the European Multicenter Study about Spinal Cord Injury Database. CCS was diagnosed based on a difference of at least ten points of motor score in favour of the lower extremities. Patients were evaluated at 30 days, 6 months and 1 year from injury. The neurological and functional data were collected at each time point based on the International Standards for Neurological Classification of Spinal Cord injury (ISNSCI) and Spinal Cord Independence Measure (SCIM). Patients were selected with a matching procedure based on lesion severity, neurological level of injury (NLI) and age. Evaluation of the outcomes was performed by means of two-way Anova for repeated measures. RESULTS: The matching produced 110 comparable dyads. At all time points, upper extremity motor scores remained lower than lower extremity motor scores in CCS compared with iCSCI. With regard to daily life independence, both cohorts achieved comparable improvements in self-care sub-scores between T0 and T2 (6.6 ± 6.5 in CCS vs 8.2 ± 6.9 in iCSCI, p = 0.15) but this sub-score was significantly lower in CCS compared with iCSCI (3.6 ± 5.2 in CCS vs 7.3 ± 7.0 in iCSCI at T0, 13.7 ± 6.2 vs 16.5 ± 5.7 at T2), while the other sub-scores were comparable. CONCLUSIONS: In contrast to previous reports, people with CCS have poorer outcomes of self-care ability compared with iCSCI.

My hand in my ear: a phantom limb re-induced by the illusion of body ownership in a patient with a brachial plexus lesion.

Corporeal awareness of body unity, continuity, and integrity is hardwired in the brain, even following massive deafferentation. Following peripheral limb injury, referred phantom sensations are reported frequently on the cheek and, rarely, on the ear. Here, we explore how brain plasticity mechanisms induced by multisensory stimulation of different facial regions (cheek and ear) modulate the feeling that a complete missing limb is still attached to the body. We applied the modified rubber hand illusion (RHI) paradigm following synchronous and asynchronous stimulation of the face-hand and ear-hand in the unusual case of a patient with a brachial plexus lesion, who had lost upper-left limb sensation and developed a phantom sensation of the arm restricted to the ear. He experienced a strong illusion of ownership of the rubber hand during synchronous stroking of the ear but not the cheek and reported more defined tactile sensations in his previously numb body part during the illusion than when simply touching the ear. Phantom experiences are not exclusively based on sensory memories of the once-present body periphery, they are organized into a topographic cortical map with the ear-hand area adjoining but separate from the face. Multimodal experiences specifically modulate possible remapping of ear-hand representations and generate a more defined connection between the brain's memory of the body and what one feels of the actual physical body. We suggest that RHI is a form of sensory intervention that makes the best use of residual signals from disconnected body parts after peripheral injury, evoking and controlling the limb sensations.

Adaptation and validation of the Caregiver Burden Inventory in Spinal Cord Injuries (CBI-SCI).

DESIGN: Validation cross-sectional study. OBJECTIVES: Even though caregiver burden (CB) represents a well-recognised concern among caregivers of people with a spinal cord injury (SCI), there are no specific questionnaires designed for its evaluation. This study aimed to assess the psychometric properties of the Caregiver Burden Inventory in Spinal Cord Injury (CBI-SCI), which was modified from its original version, and specifically its construct and reliability. SETTING: Multicentre study in four urban spinal units across Italy. The CBI-SCI was administered to family caregivers in outpatient clinics. METHODS: CBI-SCI was administered in a toolset composed of a sociodemographic questionnaire, the Family Strain Questionnaire-Short Form (FSQ-SF), the Short Form-36 (SF-36), and the Modified Barthel Index (MBI). The CBI-SCI construct validity was assessed through an exploratory factor analysis. The internal consistency of the questionnaire was examined using Cronbach's alpha (α) coefficient for the total scale and its subscales. Concurrent validity was evaluated performing Pearson's correlation coefficient with all instruments included in the toolset. RESULTS: The CBI-SCI was administered to 176 participants from February 2016 to September 2017. Factor analysis highlighted the five-factored structure of the questionnaire. The total scale Cronbach's α was 0.91 (p < 0.001). All the five subscales of CBI-SCI showed an acceptable internal consistency, ranging from 0.76 to 0.91 (p < 0.001). Pearson's correlation coefficients of the CBI-SCI with all the administered instruments were statistically significant (p < 0.001), showing congruent relations. CONCLUSION: The CBI-SCI, due to its validity and reliability, may represent a valuable instrument to evaluate the CB longitudinally in SCI.

Prediction of bladder outcomes after ischemic spinal cord injury: A longitudinal cohort study from the European multicenter study about spinal cord injury.

OBJECTIVE: The recovery of bladder function after spinal cord injury (SCI) is of major importance for patients and caregivers. We recently developed prediction models of bladder outcomes (defined as the capacity of storing the urine and emptying completely the bladder) 1 year after a SCI of traumatic etiology and investigated if these models would also be applicable to patients with ischemic SCI. PATIENTS AND METHODS: From the European multicenter study about spinal cord injury (EMSCI), we extracted data of all ischemic SCI patients with available neurological and functional data (according to the International Standards for Neurological Classification of Spinal Cord Injury, ISNCSCI, and Spinal Cord Independence Measure, SCIM) within 40 days and bladder outcomes 1 year after ischemia. The model relies on three predictors: strength of the legs, the presence of sensation in the S3 dermatome, and the part of the SCIM assessing breathing and bladder and bowel control. A simplified model relying on leg strength only was also tested. Bladder outcomes were evaluated according to the score of item six of SCIM. RESULTS: In total 85 patients (56 males (66%), mean age 55 years) were included. Twenty-three patients (27%) showed complete bladder function recovery one year after ischemia. Both models showed a very good predictive power: the area under the receiver operating characteristics curve (aROC) of the two models was 0.825 and 0.822, respectively. CONCLUSIONS: Comparable to acute traumatic SCI, also in ischemic SCI the outcome of full bladder function recovery can be predicted by clinical scores, and prediction models of bladder outcomes may be applicable in clinical trials.

Lower extremity outcome measures: considerations for clinical trials in spinal cord injury.

STUDY DESIGN: This is a focused review article. OBJECTIVES: To identify important concepts in lower extremity (LE) assessment with a focus on locomotor outcomes and provide guidance on how existing outcome measurement tools may be best used to assess experimental therapies in spinal cord injury (SCI). The emphasis lies on LE outcomes in individuals with complete and incomplete SCI in Phase II-III trials. METHODS: This review includes a summary of topics discussed during a workshop focusing on LE function in SCI, conceptual discussion of corresponding outcome measures and additional focused literature review. RESULTS: There are a number of sensitive, accurate, and responsive outcome tools measuring both quantitative and qualitative aspects of LE function. However, in trials with individuals with very acute injuries, a baseline assessment of the primary (or secondary) LE outcome measure is often not feasible. CONCLUSION: There is no single outcome measure to assess all individuals with SCI that can be used to monitor changes in LE function regardless of severity and level of injury. Surrogate markers have to be used to assess LE function in individuals with severe SCI. However, it is generally agreed that a direct measurement of the performance for an appropriate functional activity supersedes any surrogate marker. LE assessments have to be refined so they can be used across all time points after SCI, regardless of the level or severity of spinal injury. SPONSORS: Craig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.

Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials.

STUDY DESIGN: This is a focused review article. OBJECTIVES: This review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presented as well as strengths and recommendations for upper extremity COAs for research. Clinical trial tools and designs to address recruitment challenges are identified. METHODS: The methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review. RESULTS: COAs must be appropriate to trial phase and particularly in mid-late-phase trials, should reflect recovery vs. compensation, as well as being clinically meaningful. The impact and extent of upper vs. lower motoneuron disease should be considered, as this may affect how an individual may respond to a given therapeutic. For trials with broad inclusion criteria, the content of COAs should cover all severities and levels of SCI. Specific measures to assess upper extremity function as well as more comprehensive COAs are under development. In addition to appropriate use of COAs, methods to increase recruitment, such as adaptive trial designs and prognostic modeling to prospectively stratify heterogeneous populations into appropriate cohorts should be considered. CONCLUSIONS: With an increasing number of clinical trials focusing on improving upper extremity function, it is essential to consider a range of factors when choosing a COA. SPONSORS: Craig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.

The Rehabilitation of Spinal Cord Injury Patients in Europe.

In Western European countries there is an incidence of traumatic spinal cord injury (SCI) of 16 to 19.4 new cases per million inhabitants per year. Since World War II, European physicians have been fundamental in the development of SCI medicine, starting from Sir Ludwig Guttman, who developed the idea of the integrated treatment of these patients. More recently, scientists from Germany and Switzerland have developed a new rehabilitative approach, Body Weight Support Treadmill Training, based on the concept of activity-based therapy and aimed at restoring walking in SCI patients. This review highlights issues concerning different organizational systems and health policies within and outside Europe.

Prediction of Bladder Outcomes after Traumatic Spinal Cord Injury: A Longitudinal Cohort Study.

BACKGROUND: Neurogenic bladder dysfunction represents one of the most common and devastating sequelae of traumatic spinal cord injury (SCI). As early prediction of bladder outcomes is essential to counsel patients and to plan neurourological management, we aimed to develop and validate a model to predict urinary continence and complete bladder emptying 1 y after traumatic SCI. METHODS AND FINDINGS: Using multivariate logistic regression analysis from the data of 1,250 patients with traumatic SCI included in the European Multicenter Spinal Cord Injury study, we developed two prediction models of urinary continence and complete bladder emptying 1 y after traumatic SCI and performed an external validation in 111 patients. As predictors, we evaluated age, gender, and all variables of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and of the Spinal Cord Independence Measure (SCIM). Urinary continence and complete bladder emptying 1 y after SCI were assessed through item 6 of SCIM. The full model relies on lower extremity motor score (LEMS), light-touch sensation in the S3 dermatome of ISNCSI, and SCIM subscale respiration and sphincter management: the area under the receiver operating characteristics curve (aROC) was 0.936 (95% confidence interval [CI]: 0.922-0.951). The simplified model is based on LEMS only: the aROC was 0.912 (95% CI: 0.895-0.930). External validation of the full and simplified models confirmed the excellent predictive power: the aROCs were 0.965 (95% CI: 0.934-0.996) and 0.972 (95% CI 0.943-0.999), respectively. This study is limited by the substantial number of patients with a missing 1-y outcome and by differences between derivation and validation cohort. CONCLUSIONS: Our study provides two simple and reliable models to predict urinary continence and complete bladder emptying 1 y after traumatic SCI. Early prediction of bladder function might optimize counselling and patient-tailored rehabilitative interventions and improve patient stratification in future clinical trials.

International Retrospective Comparison of Inpatient Rehabilitation for Patients With Spinal Cord Dysfunction: Differences According to Etiology.

OBJECTIVES: To describe and compare epidemiologic characteristics and clinical outcomes of patients with nontraumatic spinal cord dysfunction according to etiology. DESIGN: Retrospective, multicenter open-cohort case series. SETTING: Spinal rehabilitation units (SRUs) in 9 countries. PARTICIPANTS: Patients (N=956; men, 60.8%; median age, 59.0y [interquartile range, 46-70.0y]; paraplegia, n=691 [72.3%]) with initial onset of spinal cord dysfunction consecutively admitted between January 1, 2008, and December 31, 2010. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Etiology of spinal cord dysfunction, demographic characteristics, length of stay (LOS) in rehabilitation, pattern of spinal cord dysfunction onset, discharge destination, level of spinal cord damage, and the American Spinal Injury Association Impairment Scale (AIS) grade on admission and discharge. RESULTS: The most common etiologies were degenerative (30.8%), malignant tumors (16.2%), infections (12.8%), ischemia (10.9%), benign tumors (8.7%), other vascular (8.5%), and other conditions (12.1%). There were major differences in epidemiologic characteristics and clinical outcomes of patients with different etiologies of spinal cord dysfunction. Paraplegia was more common in patients with a malignant tumor and vascular etiologies, while tetraplegia was more common in those with a degenerative etiology, a benign tumor, and infections. Patients with a malignant tumor tended to have the shortest LOS in the SRU, while those with a vascular etiology tended to have the longest. Except for patients with a malignant tumor, all patient groups had a significant change in their AIS grade between admission and discharge. CONCLUSIONS: This international study of spinal cord dysfunction showed substantial variation between the different etiologies regarding demographic and clinical characteristics, including changes in AIS between admission and discharge.