Randomised, double-blind, placebo-controlled, parallel-group, multicentric, phase IIA clinical trial for evaluating the safety, tolerability, and therapeutic efficacy of daily oral administration of NFX88 to treat neuropathic pain in individuals with spinal cord injury.

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.

First-in-human demonstration of floating EMG sensors and stimulators wirelessly powered and operated by volume conduction.

BACKGROUND: Recently we reported the design and evaluation of floating semi-implantable devices that receive power from and bidirectionally communicate with an external system using coupling by volume conduction. The approach, of which the semi-implantable devices are proof-of-concept prototypes, may overcome some limitations presented by existing neuroprostheses, especially those related to implant size and deployment, as the implants avoid bulky components and can be developed as threadlike devices. Here, it is reported the first-in-human acute demonstration of these devices for electromyography (EMG) sensing and electrical stimulation. METHODS: A proof-of-concept device, consisting of implantable thin-film electrodes and a nonimplantable miniature electronic circuit connected to them, was deployed in the upper or lower limb of six healthy participants. Two external electrodes were strapped around the limb and were connected to the external system which delivered high frequency current bursts. Within these bursts, 13 commands were modulated to communicate with the implant. RESULTS: Four devices were deployed in the biceps brachii and the gastrocnemius medialis muscles, and the external system was able to power and communicate with them. Limitations regarding insertion and communication speed are reported. Sensing and stimulation parameters were configured from the external system. In one participant, electrical stimulation and EMG acquisition assays were performed, demonstrating the feasibility of the approach to power and communicate with the floating device. CONCLUSIONS: This is the first-in-human demonstration of EMG sensors and electrical stimulators powered and operated by volume conduction. These proof-of-concept devices can be miniaturized using current microelectronic technologies, enabling fully implantable networked neuroprosthetics.

A comparison of elbow and wrist kinematics and kinetics during swing-through versus reciprocal gait with crutches in persons with incomplete spinal cord injury.

STUDY DESIGN: Descriptive study with cross-sectional data collection. OBJECTIVES: To analyse and compare the 3D kinematics and kinetics of thorax, elbow and wrist, and the spatio-temporal parameters during swing-through gait (SG) and reciprocal gait (RG). SETTING: Hospital Nacional de Parapléjicos in Toledo, Spain. METHODS: An instrumented biomechanical analysis of the upper body of 15 adults with an incomplete lumbar or thoracic spinal cord injury was performed using a marker motion capture system and load cell crutches. Five walks of each gait pattern were analysed. RESULTS: The elbow was in flexion, valgus and pronation and the wrist was in extension and ulnar deviation in both SG and RG. Their kinematic patterns were quite similar, except in elbow valgus and wrist extension in which statistically significant differences were observed. In the thorax prevailed flexion movement in SG and rotation movement in RG. The reaction forces in the elbow and the wrist were notably higher in SG than in RG, but the joint moments were similar in both gait patterns. CONCLUSIONS: SG showed greater demands and RG showed higher requirements on trunk motor control. In addition, SG could increase the probability of back and neck pain. Therefore RG should be recommended, whenever possible, in incomplete spinal cord injured people. Rehabilitative management should consider adapting properly the crutch height and the inclination cane, loading the minimum weight on the crutches, using cushioning devices, reducing the duration of support phase, and limiting the overall use time of the crutches.

Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial.

BACKGROUND: In recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore, the user-to-robot adaptation mechanisms responsible for functional improvement are still not adequately unveiled. This study aimed to (1) assess the safety and feasibility of using the HANK exoskeleton for walking rehabilitation, and (2) investigate the effects on walking function after a training program with it. METHODS: A randomized controlled trial was conducted including a cohort of 23 patients with less than 1 year since injury, neurological level of injury (C2-L4) and severity (American Spinal Cord Injury Association Impairment Scale [AIS] C or D). The intervention was comprised of 15 one-hour gait training sessions with lower limb exoskeleton HANK. Safety was assessed through monitoring of adverse events, and pain and fatigue through a Visual Analogue Scale. LEMS, WISCI-II, and SCIM-III scales were assessed, along with the 10MWT, 6MWT, and the TUG walking tests (see text for acronyms). RESULTS: No major adverse events were reported. Participants in the intervention group (IG) reported 1.8 cm (SD 1.0) for pain and 3.8 (SD 1.7) for fatigue using the VAS. Statistically significant differences were observed for the WISCI-II for both the "group" factor (F = 16.75, p < 0.001) and "group-time" interactions (F = 8.87; p < 0.01). A post-hoc analysis revealed a statistically significant increase of 3.54 points (SD 2.65, p < 0.0001) after intervention for the IG but not in the CG (0.7 points, SD 1.49, p = 0.285). No statistical differences were observed between groups for the remaining variables. CONCLUSIONS: The use of HANK exoskeleton in clinical settings is safe and well-tolerated by the patients. Patients receiving treatment with the exoskeleton improved their walking independence as measured by the WISCI-II after the treatment.

A qualitative study to elicit user requirements for lower limb wearable exoskeletons for gait rehabilitation in spinal cord injury.

OBJECTIVE: We aim to determine a comprehensive set of requirements, perceptions, and expectations that people with spinal cord injury (SCI) and the clinicians in charge of their rehabilitation have regarding the use of wearable robots (WR) for gait rehabilitation. BACKGROUND: There are concerns due to the limited user acceptance of WR for gait rehabilitation. Developers need to emphasize understanding the needs and constraints of all stakeholders involved, including the real-life dynamics of rehabilitation centers. METHODS: 15 people with SCI, 9 without experience with WR and 6 with experience with these technologies, and 10 clinicians from 3 rehabilitation centers in Spain were interviewed. A directed content analysis approach was used. RESULTS: 78 codes grouped into 9 categories (physical results, usability, psychology-related codes, technical characteristics, activities, acquisition issues, context of use, development of the technologies and clinical rehabilitation context) were expressed by at least 20% of the users interviewed, of whom 16 were not found in the literature. The agreement percentage between each group and subgroup included in the study, calculated as the number of codes that more than 20% of both groups expressed, divided over the total amount of codes any of those two groups agreed on (≥ 20%), showed limited agreement between patients and clinicians (50.00%) and between both types of patients (55.77%). The limited accessibility and availability of lower limb exoskeletons for gait rehabilitation arose in most of the interviews. CONCLUSIONS: The limited agreement percentage between patients and clinicians indicates that including both types of users in the design process of these technologies is important, given that their requirements are complementary. Engaging users with prior technology experience is recommended, as they often exhibit strong internal consensus and articulate well-defined requirements. This study adds up the knowledge available in the literature and the new codes found in our data, which enlighten important aspects that ought to be addressed in the field to develop technologies that respond to users' needs, are usable and feasible to implement in their intended contexts. APPLICATION: The set of criteria summarized in our study will be useful to guide the design, development, and evaluation of WR for gait rehabilitation to meet user's needs and allow them to be implemented in their intended context of use.

Increased Fat Oxidation During Arm Cycling Exercise in Adult Men With Spinal Cord Injury Compared With Noninjured Controls.

People with spinal cord injury (SCI) tend to be more sedentary and increase fat accumulation, which could have a negative influence on metabolic flexibility. The aim of this study was to investigate the capacity to oxidize fat in a homogenous sample of men with thoracic SCI compared with healthy noninjured men during an arm cycling incremental test. Forty-one men, 21 with SCI and 20 noninjured controls, performed an incremental arm cycling test to determine peak fat oxidation (PFO) and the intensity of exercise that elicits PFO (Fatmax). PFO was expressed in absolute values (g/min) and relative to whole-body and upper-body lean mass ([mg·min-1]·kg-1) through three different models (adjusting by cardiorespiratory fitness and fat mass). Gross mechanical efficiency was also calculated. PFO was higher in SCI than in noninjured men (0.27 ± 0.07 vs. 0.17 ± 0.07 g/min; 5.39 ± 1.30 vs. 3.29 ± 1.31 [mg·min-1]·kg-1 whole-body lean mass; 8.28 ± 2.11 vs. 5.08 ± 2.12 [mg·min-1]·kg-1 upper-body lean mass). Fatmax was found at a significantly higher percentage of VO2peak in men with SCI (33.6% ± 8.2% vs. 23.6% ± 6.4%). Differences persisted and even increased in the fully adjustment model and at any intensity. Men with SCI showed significantly higher gross mechanical efficiency at 35 and 65 W than the noninjured group. Men with SCI showed higher fat oxidation when compared with noninjured men at any intensity, even increased after full adjustment for lean mass, fat mass, and cardiorespiratory fitness. These findings suggest that SCI men could improve their metabolic flexibility and muscle mass for greater efficiency, not being affected by their fat accumulation.

Effect of posture and body weight loading on spinal posterior root reflex responses.

The posterior root muscle response (PRM) is a monosynaptic reflex that is evoked by single pulse transcutaneous spinal cord stimulation (tSCS). The main aim of this work was to analyse how body weight loading influences PRM reflex threshold measured from several lower limb muscles in healthy participants. PRM reflex responses were evoked with 1-ms rectangular monophasic pulses applied at an interval of 6 s via a self-adhesive electrode (9 × 5 cm) at the T11-T12 vertebral level. Surface electromyographic activity of lower limb muscles was recorded during four different conditions, one in decubitus supine (DS) and the other three involving standing at 100%, 50%, and 0% body weight loading (BW). PRM threshold intensity, peak-to-peak amplitude, and latency for each muscle were analysed in different conditions study. PRM reflex threshold increased with body weight unloading compared with DS, and the largest change was observed between DS and 0% BW for the proximal muscles and between DS and 50% BW for distal muscles. Peak-to-peak amplitude analysis showed only a significant mean decrease of 34.6% (SD 10.4, p = 0.028) in TA and 53.6% (SD 15.1, p = 0.019) in GM muscles between DS and 50% BW. No significant differences were observed for PRM latency. This study has shown that sensorimotor networks can be activated with tSCS in various conditions of body weight unloading. Higher stimulus intensities are necessary to evoke reflex response during standing at 50% body weight loading. These results have practical implications for gait rehabilitation training programmes that include body weight support.

Transcranial direct current stimulation combined with robotic therapy for upper and lower limb function after stroke: a systematic review and meta-analysis of randomized control trials.

BACKGROUND: Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method able to modulate neuronal activity after stroke. The aim of this systematic review was to determine if tDCS combined with robotic therapy (RT) improves limb function after stroke when compared to RT alone. METHODS: A search for randomized controlled trials (RCTs) published prior to July 15, 2021 was performed. The main outcome was function assessed with the Fugl-Meyer motor assessment for upper extremities (FM/ue) and 10-m walking test (10MWT) for the lower limbs. As secondary outcomes, strength was assessed with the Motricity Index (MI) or Medical Research Council scale (MRC), spasticity with the modified Ashworth scale (MAS), functional independence with the Barthel Index (BI), and kinematic parameters. RESULTS: Ten studies were included for analysis (n = 368 enrolled participants). The results showed a non-significant effect for tDCS combined with RT to improve upper limb function [standardized mean difference (SMD) = - 0.12; 95% confidence interval (CI): - 0.35-0.11)]. However, a positive effect of the combined therapy was observed in the lower limb function (SMD = 0.48; 95% CI: - 0.15-1.12). Significant results favouring tDCS combined with RT were not found in strength (SMD = - 0.15; 95% CI: - 0.4-0.1), spasticity [mean difference (MD) = - 0.15; 95% CI: - 0.8-0.5)], functional independence (MD = 2.5; 95% CI: - 1.9-6.9) or velocity of movement (SMD = 0.06; 95% CI: - 0.3-0.5) with a "moderate" or "low" recommendation level according to the GRADE guidelines. CONCLUSIONS: Current findings suggest that tDCS combined with RT does not improve upper limb function, strength, spasticity, functional independence or velocity of movement after stroke. However, tDCS may enhance the effects of RT alone for lower limb function. tDCS parameters and the stage or type of stroke injury could be crucial factors that determine the effectiveness of this therapy.

Cardiorespiratory fitness and arm bone mineral health in young males with spinal cord injury: the mediator role of lean mass.

Spinal cord injury (SCI) derives in loss of bone mineral content (BMC) and bone mineral density (BMD). However, physical activity is an important determinant in bone mass acquisition, which is partially mediated through the lean mass (LM). The aim was to examine the effect of cardiorespiratory fitness (CRF) on BMD and BMC arms of adult males with SCI and able-bodied controls using the arm LM as a mediator variable. Thirty able-bodied men and thirty men with SCI participated. BMC and BMD were analysed by DXA, and indirect calorimetry was used to calculate VO2peak during a progressive arm-cranking test. When groups were divided by the amount of LM, the subgroup with highest LM had significantly higher arm BMC compared to the lowest LM subgroup (p ≤ 0.05) in both SCI and able-bodied groups. Moreover, same differences were found when confidence intervals were analysed. Only in the SCI group, arm LM mediated the relationship between bone mass and CRF at 30.9%, as indicated by the Sobel test (z = 2.17 and z = 2.04 for BMC and BMD, respectively). In conclusion, LM mediates the indirect association between CRF and bone health, specifically in the arms. This finding highlights the importance of having an adequate CRF for the maintenance of good bone health in SCI men.

A Systematic Methodology to Analyze the Impact of Hand-Rim Wheelchair Propulsion on the Upper Limb.

Manual wheelchair propulsion results in physical demand of the upper limb extremities that, because of its repetitive nature, can lead to chronic pathologies on spinal cord injury patients. The aim of this study was to design and test a methodology to compare kinematic and kinetic variables of the upper limb joints when propelling different wheelchairs. Moreover, this methodology was used to analyze the differences that may exist between paraplegic and tetraplegic patients when propelling two different wheelchairs. Five adults with paraplegia and five adults with tetraplegia performed several propulsion tests. Participants propelled two different wheelchairs for three minutes at 0.833 m/s (3 km/h) with one minute break between the tests. Kinematic and kinetic variables of the upper limb as well as variables with respect to the propulsion style were recorded. Important differences in the kinetic and kinematic variables of the joints of the upper limb were found when comparing paraplegic and tetraplegic patients. Nevertheless, this difference depends on the wheelchair used. As expected, in all tests, the shoulder shows to be the most impacted joint.

Spinal cord injury in pediatric age in Spain. Reality of a national reference center.

UNLABELLED: The aim of this study was to analyze the incidence and the main characteristics of ambulant children with spinal cord injury (SCI) treated at the Unit of Biomechanics and Technical Assistance, at the National Spinal Cord Injury Hospital in Toledo, Spain. To date, there are no detailed studies on the effects of this disease in children regarding their walking ability. MATERIAL AND METHODS: A retrospective study was performed including all patients attending the unit between January 2006 and December 2013, who were aged 18 years or younger and who were outpatients able to walk independently for at least 10 m, with or without technical aids. RESULTS: Forty-eight patients were included in this study (25 males and 23 females) aged between 2 and 18 years (mean age, 12 ± 2.31 years). The etiology of SCI ranged between congenital (33.33%), traumatic (29.16%), and neoplastic (8.33%), and the level of injury varied between cervical (31.25%), lumbar (29.16%), a non-spinal origin (20.83%), dorsal (16.66%), and sacral (2.08%). The mean score on the Barthel Index was 82.61, the mean value of the Functional Independence Measure (FIM) locomotion score was 6.4, and 29 patients did not require the use of walking aids (WISCI 20). CONCLUSION: The findings of this study contribute to the knowledge regarding the situation of children with SCI in Spain. The incidence of pediatric SCI is very low; however, the provision of care remains a personal and social challenge.

Continuous decoding of movement intention of upper limb self-initiated analytic movements from pre-movement EEG correlates.

BACKGROUND: Brain-machine interfaces (BMI) have recently been integrated within motor rehabilitation therapies by actively involving the central nervous system (CNS) within the exercises. For instance, the online decoding of intention of motion of a limb from pre-movement EEG correlates is being used to convert passive rehabilitation strategies into active ones mediated by robotics. As early stages of upper limb motor rehabilitation usually focus on analytic single-joint mobilizations, this paper investigates the feasibility of building BMI decoders for these specific types of movements. METHODS: Two different experiments were performed within this study. For the first one, six healthy subjects performed seven self-initiated upper-limb analytic movements, involving from proximal to distal articulations. For the second experiment, three spinal cord injury patients performed two of the previously studied movements with their healthy elbow and paralyzed wrist. In both cases EEG neural correlates such as the event-related desynchronization (ERD) and movement related cortical potentials (MRCP) were analyzed, as well as the accuracies of continuous decoders built using the pre-movement features of these correlates (i.e., the intention of motion was decoded before movement onset). RESULTS: The studied movements could be decoded in both healthy subjects and patients. For healthy subjects there were significant differences in the EEG correlates and decoding accuracies, dependent on the moving joint. Percentages of correctly anticipated trials ranged from 75% to 40% (with chance level being around 20%), with better performances for proximal than for distal movements. For the movements studied for the SCI patients the accuracies were similar to the ones of the healthy subjects. CONCLUSIONS: This paper shows how it is possible to build continuous decoders to detect movement intention from EEG correlates for seven different upper-limb analytic movements. Furthermore we report differences in accuracies among movements, which might have an impact on the design of the rehabilitation technologies that will integrate this new type of information. The applicability of the decoders was shown in a clinical population, with similar performances between healthy subjects and patients.

Hybrid FES-robot cooperative control of ambulatory gait rehabilitation exoskeleton.

Robotic and functional electrical stimulation (FES) approaches are used for rehabilitation of walking impairment of spinal cord injured individuals. Although devices are commercially available, there are still issues that remain to be solved. Control of hybrid exoskeletons aims at blending robotic exoskeletons and electrical stimulation to overcome the drawbacks of each approach while preserving their advantages. Hybrid actuation and control have a considerable potential for walking rehabilitation but there is a need of novel control strategies of hybrid systems that adequately manage the balance between FES and robotic controllers. Combination of FES and robotic control is a challenging issue, due to the non-linear behavior of muscle under stimulation and the lack of developments in the field of hybrid control. In this article, a cooperative control strategy of a hybrid exoskeleton is presented. This strategy is designed to overcome the main disadvantages of muscular stimulation: electromechanical delay and change in muscle performance over time, and to balance muscular and robotic actuation during walking.Experimental results in healthy subjects show the ability of the hybrid FES-robot cooperative control to balance power contribution between exoskeleton and muscle stimulation. The robotic exoskeleton decreases assistance while adequate knee kinematics are guaranteed. A new technique to monitor muscle performance is employed, which allows to estimate muscle fatigue and implement muscle fatigue management strategies. Kinesis is therefore the first ambulatory hybrid exoskeleton that can effectively balance robotic and FES actuation during walking. This represents a new opportunity to implement new rehabilitation interventions to induce locomotor activity in patients with paraplegia.Acronym list: 10 mWT: ten meters walking test; 6 MWT: six minutes walking test; FSM: finite-state machine; t-FSM: time-domain FSM; c-FSM: cycle-domain FSM; FES: functional electrical stimulation; HKAFO: hip-knee-ankle-foot orthosis; ILC: iterative error-based learning control; MFE: muscle fatigue estimator; NILC: Normalized stimulation output from ILC controller; PID: Proportional-Integral-derivative Control; PW: Stimulation pulse width; QUEST: Quebec User Evaluation of Satisfaction with assistive Technology; SCI: Spinal cord injury; TTI: torque-time integral; VAS: Visual Analog Scale.

Brain-computer interface enhanced by virtual reality training for controlling a lower limb exoskeleton.

This study explores the use of a brain-computer interface (BCI) based on motor imagery (MI) for the control of a lower limb exoskeleton to aid in motor recovery after a neural injury. The BCI was evaluated in ten able-bodied subjects and two patients with spinal cord injuries. Five able-bodied subjects underwent a virtual reality (VR) training session to accelerate training with the BCI. Results from this group were compared with a control group of five able-bodied subjects, and it was found that the employment of shorter training by VR did not reduce the effectiveness of the BCI and even improved it in some cases. Patients gave positive feedback about the system and were able to handle experimental sessions without reaching high levels of physical and mental exertion. These results are promising for the inclusion of BCI in rehabilitation programs, and future research should investigate the potential of the MI-based BCI system.

Brain-machine interface based on transfer-learning for detecting the appearance of obstacles during exoskeleton-assisted walking.

Introduction: Brain-machine interfaces (BMIs) attempt to establish communication between the user and the device to be controlled. BMIs have great challenges to face in order to design a robust control in the real field of application. The artifacts, high volume of training data, and non-stationarity of the signal of EEG-based interfaces are challenges that classical processing techniques do not solve, showing certain shortcomings in the real-time domain. Recent advances in deep-learning techniques open a window of opportunity to solve some of these problems. In this work, an interface able to detect the evoked potential that occurs when a person intends to stop due to the appearance of an unexpected obstacle has been developed. Material and methods: First, the interface was tested on a treadmill with five subjects, in which the user stopped when an obstacle appeared (simulated by a laser). The analysis is based on two consecutive convolutional networks: the first one to discern the intention to stop against normal walking and the second one to correct false detections of the previous one. Results and discussion: The results were superior when using the methodology of the two consecutive networks vs. only the first one in a cross-validation pseudo-online analysis. The false positives per min (FP/min) decreased from 31.8 to 3.9 FP/min and the number of repetitions in which there were no false positives and true positives (TP) improved from 34.9% to 60.3% NOFP/TP. This methodology was tested in a closed-loop experiment with an exoskeleton, in which the brain-machine interface (BMI) detected an obstacle and sent the command to the exoskeleton to stop. This methodology was tested with three healthy subjects, and the online results were 3.8 FP/min and 49.3% NOFP/TP. To make this model feasible for non-able bodied patients with a reduced and manageable time frame, transfer-learning techniques were applied and validated in the previous tests, and were then applied to patients. The results for two incomplete Spinal Cord Injury (iSCI) patients were 37.9% NOFP/TP and 7.7 FP/min.

Construct Validity of the Gait Deviation Index for People With Incomplete Spinal Cord Injury (GDI-SCI).

BACKGROUND: The Gait Deviation Index for Spinal Cord Injury (SCI-GDI) was recently proposed as a dimensionless multivariate kinematic measure based on 21 gait features derived from 3-dimensional kinematic data which quantifies gait impairment of adult population with incomplete spinal cord injury (iSCI) relative to the normative gait of a healthy group. Nevertheless, no validity studies of the SCI-GDI have been published to date. OBJECTIVE: To assess the construct validity of the SCI-GDI in adult population following iSCI. Methods. SCI-GDI data were obtained from a sample of 50 healthy volunteers and 35 adults with iSCI. iSCI group was also assessed with the following measures: 10-Meter Walk Test (10MWT) at both self-selected (SS) and maximum speeds, Timed Up and Go Test (TUGT), SS and maximum levels of the Walking Index for Spinal Cord Injury (WISCI) II, mobility items of the Spinal Cord Independence Measure III (SCIM IIIIOMob), Lower Extremity Motor Score (LEMS), and Modified Ashworth Scale (MAS). Spearman's correlation coefficient was used to investigate the relationship with the SCI-GDI. RESULTS: SCI-GDI shows strong correlation with the 10MWT (r ≥ -.716) and good correlation with LEMS (r = .638), TUGT (r = -.582), SS WISCI II levels (r = .521), and SCIM IIIIOMob (r = .501). No significant correlations were found with maximum WISCI II levels and MAS (P > .006). CONCLUSIONS: Construct validity of the SCI-GDI was demonstrated with the 10MWT, TUGT, LEMS, SCIM IIIIOMob, and SS WISCI II levels for independently walking adults with iSCI. Future work will include assessing the psychometric characteristics with a more heterogeneous sample, also considering the pediatric population.

Powering Electronic Implants by High Frequency Volume Conduction: In Human Validation.

OBJECTIVE: Wireless power transfer (WPT) is used as an alternative to batteries to accomplish miniaturization in electronic medical implants. However, established WPT methods require bulky parts within the implant or cumbersome external systems, hindering minimally invasive deployments and the development of networks of implants. As an alternative, we propose a WPT approach based on volume conduction of high frequency (HF) current bursts. These currents are applied through external electrodes and are collected by the implants through two electrodes at their opposite ends. This approach avoids bulky components, enabling the development of flexible threadlike implants. METHODS: We study in humans if HF (6.78 MHz) current bursts complying with safety standards and applied through two textile electrodes strapped around a limb can provide substantial powers from pairs of implanted electrodes. RESULTS: Time averaged electric powers obtained from needle electrodes (diameter = 0.4 mm, length = 3 mm, separation = 30 mm) inserted into arms and lower legs of five healthy participants were 5.9 ± 0.7 mW and 2.4 ± 0.3 mW respectively. We also characterize the coupling between the external system and the implants using personalized two-port impedance models generated from medical images. CONCLUSIONS: The results demonstrate that innocuous and imperceptible HF current bursts that flow through the tissues by volume conduction can be used to wirelessly power threadlike implants. SIGNIFICANCE: This is the first time that WPT based on volume conduction is demonstrated in humans. This method overcomes the limitations of existing WPT methods in terms of minimal invasiveness and usability.

Online assessment of human-robot interaction for hybrid control of walking.

Restoration of walking ability of Spinal Cord Injury subjects can be achieved by different approaches, as the use of robotic exoskeletons or electrical stimulation of the user's muscles. The combined (hybrid) approach has the potential to provide a solution to the drawback of each approach. Specific challenges must be addressed with specific sensory systems and control strategies. In this paper we present a system and a procedure to estimate muscle fatigue from online physical interaction assessment to provide hybrid control of walking, regarding the performances of the muscles under stimulation.