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Study Design: Double-blind, randomized, placebo-controlled, parallel-group multicentric phase IIA clinical trial., Objective: To assess the safety and tolerability of oral administration of NFX-88 in subjects with chronic spinal cord injury (SCI) and explore its efficacy in pain control., Setting: A total of 7 spinal cord injury rehabilitation units in Spain., Methods: A total of 61 adult with traumatic complete or incomplete spinal cord injury (C4-T12 level), were randomised 1:1:1:1 to a placebo, NFX88 1.05 g, 2.1 g, 4.2 g/day for up to 12 weeks. The placebo or NFX-88 was administered as add-on therapy to pre-existing pregabalin (150-300 mg per day). Safety and tolerability were evaluated, and the Visual Analogue Scale (VAS) was the primary measure to explore the efficacy of NFX-88 in pain control., Results: No severe treatment-related adverse effects were reported for any of the four study groups. 44 SCI individuals completed the study and were analysed. The data obtained from the VAS analysis and the PainDETECT Questionnaire (PD-Q) suggested that the combination of NFX88 with pregabalin is more effective than pregabalin with placebo at reducing neuropathic pain (NP) in individuals with SCI and that the dose 2.10 g/day causes the most dramatic pain relief., Conclusions: NFX88 treatment was found to be highly safe and well tolerated, with the dose of 2.10 g/day being the most effective at causing pain relief. Thus, the promising efficacy of this first-in-class lipid mediator deserves further consideration in future clinical trials., (© 2024. The Author(s).)

Background: Understanding the links between gait disorders, impairments, and activity limitations is essential for correctly interpreting the instrumented gait analysis. We aimed to evaluate the relationships between spatiotemporal parameters and clinical outcomes in children with bilateral spastic cerebral palsy, and find out whether spatiotemporal parameters provide clinical information regarding gait pattern and walking., Methods: Data from 19 children with bilateral spastic cerebral palsy (nine males, ten females, 9.6 ± 2.8 years old) were collected retrospectively. All children underwent an instrumented gait analysis and a standardized clinical assessment. Seven spatiotemporal parameters were calculated: non-dimensional cadence, stride length, step width, gait speed, first double support, single support, and time of toe off. Clinical outcomes included measures of two different components of the International Classification of Functioning, Disability and Health - Children and Youth version: body functions and structures (spasticity, contractures and range of motion, and deformities), and activities and participation (gross motor function, and walking capacity). Pearson correlation, ANOVA, Student's t, Mann-Whitney U, and Kruskal-Wallis tests were used to analyze relationships. Spatiotemporal parameters related to clinical outcomes of body functions and structures were interpreted as outcome measures of gait pattern, while those related to clinical outcomes of activities and participation were interpreted as outcome measures of walking., Results: Non-dimensional cadence, stride length, and gait speed showed relationships (p < 0.05) with hip flexors spasticity and hindfoot deformity, ankle plantar flexors spasticity, and hindfoot deformity, respectively. All spatiotemporal parameters except non-dimensional cadence showed correlation (p < 0.05) with gross motor function and walking capacity., Conclusions: Spatiotemporal parameters provide clinical information regarding both gait pattern and walking., Competing Interests: Declaration of competing interest None., (Copyright © 2022 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.)

(1) Background: the use of Mesenchymal Stromal Cells (MSC) in emerging therapies for spinal cord injury (SCI) hold the potential to improve functional recovery. However, the development of cell-based medicines is challenging and preclinical studies addressing quality, safety and efficacy must be conducted prior to clinical testing; (2) Methods: herein we present (i) the characterization of the quality attributes of MSC from the Wharton's jelly (WJ) of the umbilical cord, (ii) safety of intrathecal infusion in a 3-month subchronic toxicity assessment study, and (iii) efficacy in a rat SCI model by controlled impaction (100 kdynes) after single (day 7 post-injury) and repeated dose of 1 × 10 6 MSC,WJ (days 7 and 14 post-injury) with 70-day monitoring by electrophysiological testing, motor function assessment and histology evaluation; (3) Results: no toxicity associated to MSC,WJ infusion was observed. Regarding efficacy, recovery of locomotion was promoted at early time points. Persistence of MSC,WJ was detected early after administration (day 2 post-injection) but not at days 14 and 63 post-injection. (4) Conclusions: the safety profile and signs of efficacy substantiate the suitability of the presented data for inclusion in the Investigational Medicinal Product Dossier for further consideration by the competent Regulatory Authority to proceed with clinical trials.

Introduction: Spinal cord injury is a traumatic or non-traumatic event that causes an alteration of sensory, motor or autonomic functioning and ultimately affects the physical, psychological and social well-being of the person who suffers it. A comprehensive approach to spinal cord injury requires many health resources and can place a considerable financial burden on patients, their families and the community., Aim: To review the literature published to date on the use of non-invasive brain stimulation, including repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), and transcutaneous non-invasive spinal cord stimulation (tcSCS), as therapeutic strategies to improve the functionality of patients with spinal cord injury. The studies were grouped as addressing either non-invasive brain stimulation or non-invasive spinal cord stimulation., Development: Altogether 32 studies were identified: 21 involving brain stimulation (14 in rTMS and 7 in tDCS) and 11 with spinal cord stimulation (tcSCS). All the studies were conducted in adult patients who had undergone a spinal cord injury. Despite significant variability in treatment protocols, patient characteristics and clinical assessment, the changes observed were reported in almost all the studies without producing any side effects and with motor or functional improvement., Conclusion: Non-invasive brain stimulation, as well as spinal cord stimulation, are promising techniques for the rehabilitation of patients with spinal cord injury due to their novelty, effectiveness and minimal side effects.

Aim: To identify the gait parameters used to assess gait disorders in children with bilateral spastic cerebral palsy (CP) and evaluate their responsiveness to treatments., Method: A systematic search within PubMed, Web of Science, and Scopus (in English, 2000-2016) for randomized controlled trials of children with bilateral spastic CP who were assessed by instrumented gait analysis (IGA) was performed. Data related to participants and study characteristics, risk of bias, and outcome measures were collected. A list of gait parameters responsive to clinical interventions was obtained., Results: Twenty-one articles met the inclusion criteria. Eighty-nine gait parameters were identified, 56 of which showed responsiveness to treatments. Spatiotemporal and kinematic parameters were widely used compared to kinetic and surface electromyography data. The majority of responsive gait parameters were joint angles at the sagittal plane (flexion-extension)., Interpretation: The IGA yields responsive outcome measures for the gait assessment of children with bilateral spastic CP. Spatiotemporal and kinematic (at sagittal plane) parameters are the gait parameters used most frequently. Further research is needed to establish the relevant gait parameters for each clinical problem., What This Paper Adds: Fifty-six responsive gait parameters for children with bilateral spastic cerebral palsy were identified. Most responsive gait parameters belong to joint angles time-series at sagittal plane. Spatiotemporal and kinematic parameters are widely used compared to kinetic and surface electromyography parameters., (© 2018 Mac Keith Press.)

Objectives: The purpose of this document is to establish practical recommendations on neurogenic bladder (NB) management based on scientific evidence and medical and nursing perspective in Spinal Cord Injury (SCI) Units as a first multidisciplinary consensual approach in Spain. METHODS: This paper reports results from the first modified Delphi consensus building exercise on this procedure. A committee of recognised opinion-leaders in rehabilitation and urology with special interest in NB was constituted. A working group formed by rehabilitation doctors, urologists and nursing staff of SCI and Neurorehabilitation Units of a number of Spanish hospitals and specialised centres associated with the panel of NB experts have prepared this document. RESULTS: This review provided an overview of the main aspects described by the different clinical guidelines already available and highlighted the need to focus on recommendations in special priority situations in which there was no consensus. In view of the considerable impact this condition has on quality of life, patients should be offered help to better understand the disorder and they should be taught how to use the treatment techniques to obtain satisfactory results and promote their autonomy. CONCLUSIONS: This article presents a version of guidelines for patients with NB. The guidelines define the clinical profile of patients to provide the best evidence- based care and also an overview of the current drug and surgical treatments of NB.

Objective: To report the clinical improvements in spinal cord injury (SCI) patients associated with intensive gait training using electromechanical systems according to patient characteristics., Design: Prospective longitudinal study., Setting: Inpatient SCI rehabilitation center., Participants: Adults with SCI (n=130)., Intervention: Patients received locomotor training with 2 different electromechanical devices, 5 days per week for 8 weeks., Main Outcome Measures: Lower-extremity motor score, Walking Index for Spinal Cord Injury, and 10-meter walking test data were collected at the baseline, midpoint, and end of the program. Patients were stratified according to the American Spinal Injury Association (ASIA) category, time since injury, and injury etiology. A subgroup of traumatic ASIA grade C and D patients were compared with data obtained from the European Multicenter Study about Human Spinal Cord Injury (EM-SCI)., Results: One hundred and five patients completed the program. Significant gains in lower-limb motor function and gait were observed for both types of electromechanical device systems, to a similar degree. The greatest rate of improvement was shown in the motor incomplete SCI patients, and for patients <6 months postinjury. The positive response associated with training was not affected by injury etiology, age, sex, or lesion level. The trajectory of improvement was significantly enhanced relative to patients receiving the conventional standard of care without electromechanical systems (EM-SCI)., Conclusions: The use of electromechanical systems for intensive gait training in SCI is associated with a marked improvement in lower-limb motor function and gait across a diverse range of patients and is most evident in motor incomplete patients, and for patients who begin the regimen early in the recovery process., (Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Aims: To determine the prevalence of neuropathic pain (NP) in a sample of patients with spinal cord injury (SCI), to examine the relation between clinical, demographic and psychological characteristics with the prevalence of NP after SCI and the different types of NP, and to study predictive factors., Patients and Methods: Transversal observational study of 260 patients who attended their annual revision. Main outcome measures included presence/absence of NP, psychological well-being index, detailed pain history and 0-10 numerical rating scale of average pain intensity., Results: 93 patients (36%) with SCI had NP. Of the patients with NP, 35% showed pain at level, while 65% showed NP below the level of injury. The only variable with a predictive value on the prevalence of NP was older age at the time of SCI. Statistically significant differences were observed between the prevalence of NP and the perception of psychological well-being; patients with NP were the ones with more psychological distress. As for the different types of NP, the variables with predictive value on the classification of NP were early onset of pain at level, and incompleteness of the lesion in the below level NP., Conclusion: The results of this study show that NP appears frequently after SCI being more prevalent in patients who suffered the injury at more advanced ages. NP has a negative impact on the perception of psychological well-being.