Robotic Postural Training With Epidural Stimulation for the Recovery of Upright Postural Control in Individuals With Motor Complete Spinal Cord Injury: A Pilot Study.

Activity-based training and lumbosacral spinal cord epidural stimulation (scES) have the potential to restore standing and walking with self-balance assistance after motor complete spinal cord injury (SCI). However, improvements in upright postural control have not previously been addressed in this population. Here, we implemented a novel robotic postural training with scES, performed with free hands, to restore upright postural control in individuals with chronic, cervical (n = 5) or high-thoracic (n = 1) motor complete SCI, who had previously undergone stand training with scES using a walker or a standing frame for self-balance assistance. Robotic postural training re-enabled and/or largely improved the participants' ability to control steady standing, self-initiated trunk movements and upper limb reaching movements while standing with free hands, receiving only external assistance for pelvic control. These improvements were associated with neuromuscular activation pattern adaptations above and below the lesion. These findings suggest that the human spinal cord below the level of injury can generate meaningful postural responses when its excitability is modulated by scES, and can learn to improve these responses. Upright postural control improvements can enhance functional motor recovery promoted by scES after severe SCI.

Combining Spinal Cord Transcutaneous Stimulation with Activity-based Training to Improve Upper Extremity Function Following Cervical Spinal Cord Injury.

Recovery of upper extremity (UE) function is the top priority following cervical spinal cord injury (SCI); even partial function restoration would greatly improve the quality of their life and thus remains an important goal in SCI rehabilitation. Current clinical therapies focus on promoting neuroplasticity by performing task-specific activities with high intensity and high repetition. Repetitive training, paired with functional electrical, somatosensory, or transcranial magnetic stimulation, has been evaluated to augment functional recovery in chronic SCI, but improvements were modest. Evidence has demonstrated that the non-invasive spinal cord transcutaneous stimulation (scTS) can increase the excitability of spinal circuits and facilitate the weak or silent descending drive for restoration of sensorimotor function. Currently, we are conducting a multicenter randomized clinical trial to investigate the efficacy and potential mechanisms of scTS combined with activity-based training (ABT) to facilitate UE function recovery in individuals with tetraplegia. The preliminary outcomes from our four individuals with complete and incomplete injury demonstrated that the combination of scTS and ABT led to immediate and sustained (for up to 1-month follow-up) UE function recovery. Notably, one individual with motor complete injury showed a 5-fold improvement in UE function quantified by the Graded Redefined Assessment of Strength, Sensibility, and Prehension following scTS+ABT, as compared to receiving ABT alone. These functional gains were also reflected in the increased spinal excitability by measuring the scTS-evoked muscle response of UE motor pools, suggesting physiological evidence of reorganization of the non-functional, but surviving spinal networks after spinal transcutaneous stimulation.Clinical Relevance-This study offered the preliminary efficacy of combining scTS and ABT to facilitate UE function recovery following cervical SCI.

Spinal Cord Stimulation with Activity-Based Training: Effect on Spasticity.

Spasticity is common after a spinal cord injury (SCI). Pharmacological treatments for spasticity often have adverse effects on neurorehabilitation. Spinal cord transcutaneous stimulation (scTS) and activity-based training (ABT) have been shown to be useful tools for neurorehabilitation which can lead to improved function for people with SCI. Our preliminary data suggests that neuromodulation of the spinal circuitry may result in attenuating spasticity.Clinical Relevance- Spasticity effects 65-70% of individuals following SCI, this technique of using ABT with scTS may allow for improvements in limiting spasticity.

Development of a Remote Version of the Graded Redefined Assessment of Strength, Sensation, and Prehension (GRASSP): Validity and Reliability.

BACKGROUND: The Graded Redefined Assessment of Strength, Sensation, and Prehension (GRASSP V1.0) was developed in 2010 as a 3-domain assessment for upper extremity function after tetraplegia (domains: Strength, Sensibility, and Prehension). A remote version (rGRASSP) was created in response to the growing needs of the field of Telemedicine. OBJECTIVE: The purpose of this study was to assess the psychometric properties of rGRASSP, establishing concurrent validity and inter-rater reliability. METHODS: Individuals with tetraplegia (n = 61) completed 2 visits: 1 in-person and 1 remote. The first visit was completed in-person to administer the GRASSP, and the second visit was conducted remotely to administer the rGRASSP. The rGRASSP was scored both by the administrator of the rGRASSP (Examiner 1), and a second assessor (Examiner 2) to establish inter-rater reliability. Agreement between the in-person and remote GRASSP evaluations was assessed using the intraclass correlation coefficient (ICC) and Bland-Altman agreement plots. RESULTS: The remote GRASSP demonstrated excellent concurrent validity with the GRASSP (left hand intraclass correlation coefficient (ICC) = .96, right ICC = .96). Concurrent validity for the domains was excellent for strength (left ICC = .96, right ICC = .95), prehension ability (left ICC = .94, right ICC = .95), and prehension performance (left ICC = .92, right ICC = .93), and moderate for sensibility (left ICC = .59, right ICC = .68). Inter-rater reliability for rGRASSP total score was high (ICC = .99), and remained high for all 4 domains. Bland-Altman plots and limits of agreements support these findings. CONCLUSIONS: The rGRASSP shows strong concurrent validity and inter-rater reliability, providing a psychometrically sound remote assessment for the upper extremity in individuals with tetraplegia.

Aging-induced alterations in EEG spectral power associated with graded force motor tasks.

BACKGROUND: It has been demonstrated that in young and healthy individuals, there is a strong association between the amplitude of EEG-derived motor activity-related cortical potential or EEG spectral power (ESP) and voluntary muscle force. This association suggests that the motor-related ESP may serve as an index of central nervous system function in controlling voluntary muscle activation Therefore, it may potentially be used as an objective marker to track changes in functional neuroplasticity due to neurological disorders, aging, and following rehabilitation therapies. To this end, the relationship between the band-specific ESP-combined spectral power of EEG oscillatory and aperiodic (noise) components-and voluntary elbow flexion (EF) force has been analyzed in elder and young individuals. METHODS: 20 young (22.6 ± 0.87 year) and 28 elderly (74.79 ± 1.37 year) participants performed EF contractions at 20%, 50%, and 80% of maximum voluntary contraction (MVC) while high-density EEG signals were recorded. Both the absolute and relative ESPs were computed for the EEG frequency bands of interest. RESULTS: The MVC force generated by the elderly was foreseeably lower than that of the young participants. Compared to young, the elderly cohort's (1) total ESP was significantly lower for the high (80% MVC) force task; (2) relative ESP in beta band was significantly elevated for the low and moderate (20% MVC and 50% MVC) force tasks; (3) absolute ESP failed to have a positive trend with force for EEG frequency bands of interest; and (4) beta-band relative ESP did not exhibit a significant decrease with increasing force levels. CONCLUSIONS: As opposed to young subjects, the beta-band relative ESP in elderly did not significantly decrease with increasing EF force values. This observation suggests the use of beta-band relative ESP as a potential biomarker for age-related motor control degeneration.

Safety and effects of a therapeutic 15 Hz rTMS protocol administered at different suprathreshold intensities in able-bodied individuals.

High-frequency repetitive transcranial magnetic stimulation (HF-rTMS) remains a promising strategy for neurorehabilitation. The stimulation intensity (SI) influences the aftereffects observed. Here, we examined whether single sessions of a 15 Hz rTMS protocol, administered at suprathreshold SI, can be safely administered to able-bodied (AB) individuals. Six right-handed men were included in this pilot study. HF-rTMS was delivered over the right M1, in 10 trains of 75 biphasic stimuli at 15 Hz, at 105-120% of the individual resting motor threshold (RMT). To assess safety, electromyography (EMG) was monitored to control for signs of spread of excitation and brief EMG burst (BEB) after stimulation. Additionally, TMS side effects questionnaires and the numeric rating scale (NRS) were administered during each session. We assessed corticospinal excitability (CSE) and motor performance changes with measures of resting (rMEP) and active (aMEP) motor evoked potential and grip strength and box and blocks test (BBT) scores, respectively. Overall, the sessions were tolerated and feasible without any pain development. However, EMG analysis during 15 Hz rTMS administration revealed increased BEB frequency with SI. Statistical models revealed an increase of CSE at rest (rMEP) but not during active muscle contraction (aMEP). No linear relationship was observed between 15 Hz rTMS SI and rMEP increase. No significant changes were highlighted for motor performance measures. Although feasible and tolerable by the AB individuals tested, the results demonstrate that when administered at suprathreshold intensities (≥ 105% RMT) the 15 Hz rTMS protocol reveals signs of persistent excitation, suggesting that safety precautions and close monitoring of participants should be performed when testing such combinations of high-intensity and high-frequency stimulation protocols. The results also give insight into the nonlinear existent relationship between the SI and HF-rTMS effects on CSE.NEW & NOTEWORTHY The results of this pilot study show the effects of a therapeutically promising 15 Hz repetitive transcranial magnetic stimulation (rTMS) protocol, administered at different suprathreshold intensities in able-bodied individuals. Although tolerable and feasible with a neuromodulatory potential, 15 Hz rTMS might result in persistent excitability that needs to be closely monitored if administered at suprathreshold stimulation intensity. These results reaffirm the importance of feasibility studies, especially in translational animal-to-human research.

Spinal Cord Transcutaneous Stimulation Enables Volitional Knee Extension in Motor-complete SCI.

Non-invasive spinal cord transcutaneous stimulation (scTS) is often applied to one or multiple spinal segments and may improve motor control after spinal cord injury (SCI). The purpose of this pilot study was to apply tonic scTS to an individual with motor-complete spinal cord injury (SCI) in order to initiate and maintain volitional control during a specific lower-extremity motor task. The participant's legs were placed in a gravity-neutral position, and he was asked to extend his knee, with and without the presence of tonic scTS. Our results show intentional voluntary control of knee extension with scTS (with no assistance). Our preliminary findings highlight how scTS neuromodulation of the spinal circuitry has the potential to restore motor function for people with motor-complete SCI. Clinical Relevance- This investigation is critical to better understand the neuromodulatory effects of tonic scTS for augmentation of voluntary-induced muscle activations in individuals with motor-complete SCI.

High-Frequency rTMS Combined with Task-Specific Hand Motor Training Modulates Corticospinal Plasticity in Motor Complete Spinal Cord Injury: A case report.

Since its first use in spinal cord injury (SCI) in the early 2000s [1], high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) demonstrated a capacity to modulate corticospinal excitability (CSE) and motor performance. Studies focused on individuals with incomplete SCI. Here, we examined the feasibility of a 15-day therapeutic stimulation protocol combining HF-rTMS with task-specific motor training targeting the weaker hand in an individual with early chronic complete SCI. In this case report, we present evidence of progressive increase of CSE at rest and during muscle activation, and decreased cortical inhibition, associated with a trend toward improvement in pinch function of the weaker hand. These promising findings need to be confirmed in a larger population. Clinical Relevance- These preliminary results are promising and demonstrate the importance of a large number of training session repetitions to induce consistent changes relevant to the recovery after a complete SCI.

Stimulation Parameters Used During Repetitive Transcranial Magnetic Stimulation for Motor Recovery and Corticospinal Excitability Modulation in SCI: A Scoping Review.

There is a growing interest in non-invasive stimulation interventions as treatment strategies to improve functional outcomes and recovery after spinal cord injury (SCI). Repetitive transcranial magnetic stimulation (rTMS) is a neuromodulatory intervention which has the potential to reinforce the residual spinal and supraspinal pathways and induce plasticity. Recent reviews have highlighted the therapeutic potential and the beneficial effects of rTMS on motor function, spasticity, and corticospinal excitability modulation in SCI individuals. For this scoping review, we focus on the stimulation parameters used in 20 rTMS protocols. We extracted the rTMS parameters from 16 published rTMS studies involving SCI individuals and were able to infer preliminary associations between specific parameters and the effects observed. Future investigations will need to consider timing, intervention duration and dosage (in terms of number of sessions and number of pulses) that may depend on the stage, the level, and the severity of the injury. There is a need for more real vs. sham rTMS studies, reporting similar designs with sufficient information for replication, to achieve a significant level of evidence regarding the use of rTMS in SCI.

Safety and efficacy of transcranial direct current stimulation in upper extremity rehabilitation after tetraplegia: protocol of a multicenter randomized, clinical trial.

STUDY DESIGN: A multisite, randomized, controlled, double-blinded phase I/II clinical trial. OBJECTIVE: The purpose of this clinical trial is to evaluate the safety, feasibility and efficacy of pairing noninvasive transcranial direct current stimulation (tDCS) with rehabilitation to promote paretic upper extremity recovery and functional independence in persons living with chronic cervical spinal cord injury (SCI). SETTING: Four-site trial conducted across Cleveland Clinic, Louis Stokes Veterans Affairs Medical Center of Cleveland and MetroHealth Rehabilitation Rehabilitation Institute of Ohio, and Kessler Foundation of New Jersey. METHODS: Forty-four adults (age ≥18 years) with tetraplegia following cervical SCI that occurred ≥1-year ago will participate. Participants will be randomly assigned to receive anodal tDCS or sham tDCS given in combination with upper extremity rehabilitation for 15 sessions each over 3-5 weeks. Assessments will be made twice at baseline separated by at least a 3-week interval, once at end-of-intervention, and once at 3-month follow-up. PRIMARY OUTCOME MEASURE(S): Primary outcome measure is upper extremity motor impairment assessed using the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) scale. Functional abilities will be assessed using Capabilities of Upper Extremity-Test (CUE-T), while functional independence and participation restrictions will be evaluated using the self-care domain of Spinal Cord Independent Measure (SCIM), and Canadian Occupational Performance Measure (COPM). SECONDARY OUTCOME MEASURES: Treatment-associated change in corticospinal excitability and output will also be studied using transcranial magnetic stimulation (TMS) and safety (reports of adverse events) and feasibility (attrition, adherence etc.) will also be evaluated. TRIAL REGISTRATION: ClincalTrials.gov identifier NCT03892746. This clinical trial is being performed at four sites within the United States: Cleveland Clinic (lead site), Louis Stokes Cleveland Veterans Affairs Medical Center (VAMC) and MetroHealth Rehabilitation Institute in Ohio, and Kessler Foundation in New Jersey. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.

Generation of a Reference Dataset to Permit the Calculation of T-scores at the Distal Femur and Proximal Tibia in Persons with Spinal Cord Injury.

Persons with traumatic spinal cord injury (SCI) have severe bone loss below the level of lesion with the distal femur (DF) and proximal tibia (PT) being the skeletal regions having the highest risk of fracture. While a reference areal bone mineral density (aBMD) database is available at the total hip (TH) using the combined National Health and Nutrition Examination Survey (NHANES) III study and General Electric (GE) combined (GE/NHANES) to calculate T-score (T-scoreGE/NHANES), no such reference database exists for aBMD of the DF, and PT. The primary objectives of this study were (1) to create a reference dataset of young-healthy able-bodied (YHAB) persons to calculate T-score (T-scoreYHAB) values at the DF and PT, (2) to explore the impact of time since injury (TSI) on relative bone loss in the DF and PT regions using the two computation models to determine T-score values, and (3) to determine agreement between T-score values for a cohort of persons with SCI using the (T-scoreYHAB) and (T-scoreGE/NHANES) reference datasets. A cross-sectional prospective data collection study. A Department of Veterans Affairs Medical Center and a Private Rehabilitation Hospital. A normative reference aBMD database at the DF and PT was collected in 32 male and 32 female Caucasian YHAB participants (n=64) and then applied to calculate T-score values at the DF and PT in 105 SCI participants from a historical cohort. The SCI participants were then grouped based on TSI epochs (E-I: TSI < 1y, E-II: TSI 1-5y, E-III: TSI 6-10y, E-IV: TSI 11-20y, E-V: TSI > 20y). N/A. The knee and hip aBMD values were obtained by dual energy X-ray absorptiometry (GE Lunar iDXA) using standard clinical software for proximal femur orthopedic knee software applications. There were no significant differences in mean aBMD values across the four YHAB age subgroups (21-25, 26-30, 31-35, and 36-40 yr of age) at the TH, DF, and PT; mean aBMD values were higher in men compared to the women at all skeletal regions of interest. Using the mean YHAB aBMD values to calculate T-score values at each TSI epoch for persons with SCI, T-score values decreased as a function of TSI, and they continued to decline for 11-20 yr. Moderate kappa agreement was noted between the YHAB and the GE/NHANES reference datasets for the T-score cutoff criteria accepted to diagnose osteoporosis (i.e., SD <-2.5). A homogeneous reference dataset of YHAB aBMD values at the DF and PT was applied to calculate T-score values in persons with chronic SCI. There was a moderate level of agreement at the TH between the YHAB and GE/NHANES reference datasets when applying the conventional T-score cutoff value for the diagnosis of osteoporosis.

Transcutaneous spinal stimulation in patients with intrathecal baclofen pump delivery system: A preliminary safety study.

Objective: To determine the effect of transcutaneous spinal stimulation (TSS) on an implanted intrathecal baclofen (ITB) pump in persons with traumatic spinal cord injury (SCI). Design: Prospective clinical trial. Participants: Five individuals with chronic traumatic SCI, >18 years of age, and an anteriorly implanted Medtronic SynchroMed™ II ITB pump delivery system. Intervention: Transcutaneous spinal stimulation trials with cathode at T11/12, with pump interrogation before, during and after stimulation. Results: There was no evidence of any effect of the TSS in regards to disruption of the ITB pump delivery mechanism. Communication interference with the interrogator to the pump occurred often during stimulation for log transmission most likely secondary to the electromagnetic interference from the stimulation. One individual had elevated blood pressure at the end of the trial, suspected to be unrelated to the spinal stimulation. Conclusion: Based upon this pilot study, further TSS studies including persons with an implanted Medtronic SynchroMed™ II ITB pump can be considered when stimulating at the low thoracic spine, although communication with the programmer during the stimulation may be affected.

Isolating Transcutaneous Spinal Cord Stimulation Artifact to Identify Motor Response during Walking.

The objective of this investigation was to demonstrate the applicability of a custom-developed EMD-Notch filtering algorithm to isolate the scTS-induced artifact from sEMG signals during walking in an individual with motor-incomplete SCI. Overall, the EMD-Notch filtering algorithm provides an effective approach to isolate the scTS artifact, extract the sEMG data, and further study the modulation of the spinal neuronal networks during dynamic activities.Clinical Relevance- This investigation will help with the modification of individualized scTS parameters to achieve task-specific neuromodulatory effects.

The Effect of Exoskeletal-Assisted Walking on Spinal Cord Injury Bowel Function: Results from a Randomized Trial and Comparison to Other Physical Interventions.

Bowel function after spinal cord injury (SCI) is compromised because of a lack of voluntary control and reduction in bowel motility, often leading to incontinence and constipation not easily managed. Physical activity and upright posture may play a role in dealing with these issues. We performed a three-center, randomized, controlled, crossover clinical trial of exoskeletal-assisted walking (EAW) compared to usual activity (UA) in people with chronic SCI. As a secondary outcome measure, the effect of this intervention on bowel function was assessed using a 10-question bowel function survey, the Bristol Stool Form Scale (BSS) and the Spinal Cord Injury Quality of Life (SCI-QOL) Bowel Management Difficulties instrument. Fifty participants completed the study, with bowel data available for 49. The amount of time needed for the bowel program on average was reduced in 24% of the participants after EAW. A trend toward normalization of stool form was noted. There were no significant effects on patient-reported outcomes for bowel function for the SCI-QOL components, although the time since injury may have played a role. Subset analysis suggested that EAW produces a greater positive effect in men than women and may be more effective in motor-complete individuals with respect to stool consistency. EAW, along with other physical interventions previously investigated, may be able to play a previously underappreciated role in assisting with SCI-related bowel dysfunction.

Cervical Spinal Cord Transcutaneous Stimulation Improves Upper Extremity and Hand Function in People With Complete Tetraplegia: A Case Study.

Recovery of the upper extremity (UE) and hand function is considered the highest priority for people with tetraplegia, because these functions closely integrate with their activities of daily living. Spinal cord transcutaneous stimulation (scTS) has great potential to facilitate functional restoration of paralyzed limbs by neuro-modulating the excitability of the spinal network. Recently, this approach has been demonstrated effective in improving UE function in people with motor complete and incomplete cervical SCI. However, the research thus far is limited by the lack of a comprehensive assessment of functional improvement and neurological recovery throughout the intervention. The goal of this study was to investigate whether scTS can also facilitate UE functional restoration in an individual with motor and sensory complete tetraplegia. A 38-year-old male with a C5 level, ASIA Impairment Scale-A SCI (15 years post-injury, left hand dominant pre- and post-injury), received 18 sessions (60 minutes/session) of scTS combined with task-specific hand training over the course of 8 weeks. The total score of the Graded Redefined Assessment of Strength, Sensibility, and Prehension significantly improved from 72/232 to 96/232 at post-intervention, and maintained ranging from 82/232 to 86/232 during the three months follow-up without any further treatment. The bilateral handgrip force improved by 283.4% (left) and 30.7% (right), respectively at post-intervention. These strength gains were sustained at 233.5% -250% (left) and 11.5%-73.1% (right) during the follow-up evaluation visits. Neuromuscular Recovery Scale demonstrated dramatic and long-lasting improvements following the completion of the intervention. Changes of spinal motor evoked potentials from pre- to post-intervention indicated an increased level of spinal network excitability. The present data offer preliminary evidence that the novel scTS intervention combined with hand training can enhance UE functional use in people with motor and sensory complete SCI.

Effects of Multi-Muscle Electrical Stimulation and Stand Training on Stepping for an Individual With SCI.

The objective of this study was to evaluate the biomechanical, neural, and functional outcomes during a 10-min treadmill stepping trial before and after two independent interventions with neuromuscular electrical stimulation (ES) in an individual with spinal cord injury (SCI). In this longitudinal study, a 34-year-old male with sensory- and motor-complete SCI (C5/C6) underwent two consecutive interventions: 61 h of supine lower limb ES (ES-alone) followed by 51 h of ES combined with stand training (ST) using an overhead body-weight support (BWS) system (ST + ES). In post ES-alone (unloaded), compared to baseline, the majority (∼60%) of lower extremity muscles decreased their peak surface electromyography (sEMG) amplitude, while in post ST + ES (loaded), compared to post ES-alone, there was a restoration in muscle activation that endured the continuous 10-min stepping. Temporal α-motor neuron activity patterns were observed for the SCI participant. In post ST + ES, there were increases in spinal activity patterns during mid-stance at spinal levels L5-S2 for the right and left limbs. Moreover, in post ES-alone, trunk stability increased with excursions from the midline of the base-of-support (50%) to the left (44.2%; Baseline: 54.2%) and right (66.4%; baseline: 77.5%). The least amount of trunk excursion observed post ST + ES, from midline to left (43%; AB: 22%) and right (64%; AB: 64%). Overall, in post ES-alone, there were gains in trunk independence with a decrease in lower limb muscle activation, whereas in post ST + ES, there were gains in trunk independence and increased muscle activation in both bilateral trunk muscles as well as lower limb muscles during the treadmill stepping paradigm. The results of the study illustrate the importance of loading during the stimulation for neural and mechanical gains.

Cardiovascular Autonomic Dysfunction in Spinal Cord Injury: Epidemiology, Diagnosis, and Management.

Spinal cord injury (SCI) disrupts autonomic circuits and impairs synchronistic functioning of the autonomic nervous system, leading to inadequate cardiovascular regulation. Individuals with SCI, particularly at or above the sixth thoracic vertebral level (T6), often have impaired regulation of sympathetic vasoconstriction of the peripheral vasculature and the splanchnic circulation, and diminished control of heart rate and cardiac output. In addition, impaired descending sympathetic control results in changes in circulating levels of plasma catecholamines, which can have a profound effect on cardiovascular function. Although individuals with lesions below T6 often have normal resting blood pressures, there is evidence of increases in resting heart rate and inadequate cardiovascular response to autonomic provocations such as the head-up tilt and cold face tests. This manuscript reviews the prevalence of cardiovascular disorders given the level, duration and severity of SCI, the clinical presentation, diagnostic workup, short- and long-term consequences, and empirical evidence supporting management strategies to treat cardiovascular dysfunction following a SCI.

Mobility Skills With Exoskeletal-Assisted Walking in Persons With SCI: Results From a Three Center Randomized Clinical Trial.

Background: Clinical exoskeletal-assisted walking (EAW) programs for individuals with spinal cord injury (SCI) have been established, but many unknown variables remain. These include addressing staffing needs, determining the number of sessions needed to achieve a successful walking velocity milestone for ambulation, distinguishing potential achievement goals according to level of injury, and deciding the number of sessions participants need to perform in order to meet the Food and Drug Administration (FDA) criteria for personal use prescription in the home and community. The primary aim of this study was to determine the number of sessions necessary to achieve adequate EAW skills and velocity milestones, and the percentage of participants able to achieve these skills by 12 sessions and to determine the skill progression over the course of 36 sessions. Methods: A randomized clinical trial (RCT) was conducted across three sites, in persons with chronic (≥6 months) non-ambulatory SCI. Eligible participants were randomized (within site) to either the EAW arm first (Group 1), three times per week for 36 sessions, striving to be completed in 12 weeks or the usual activity arm (UA) first (Group 2), followed by a crossover to the other arm for both groups. The 10-meter walk test seconds (s) (10MWT), 6-min walk test meters (m) (6MWT), and the Timed-Up-and-Go (s) (TUG) were performed at 12, 24, and 36 sessions. To test walking performance in the exoskeletal devices, nominal velocities and distance milestones were chosen prior to study initiation, and were used for the 10MWT (≤ 40s), 6MWT (≥80m), and TUG (≤ 90s). All walking tests were performed with the exoskeletons. Results: A total of 50 participants completed 36 sessions of EAW training. At 12 sessions, 31 (62%), 35 (70%), and 36 (72%) participants achieved the 10MWT, 6MWT, and TUG milestones, respectively. By 36 sessions, 40 (80%), 41 (82%), and 42 (84%) achieved the 10MWT, 6MWT, and TUG criteria, respectively. Conclusions: It is feasible to train chronic non-ambulatory individuals with SCI in performance of EAW sufficiently to achieve reasonable mobility skill outcome milestones.

Dynamic Margins of Stability During Robot-Assisted Walking in Able-Bodied Individuals: A Preliminary Study.

Background: Gait analysis studies during robot-assisted walking have been predominantly focused on lower limb biomechanics. During robot-assisted walking, the users' interaction with the robot and their adaptations translate into altered gait mechanics. Hence, robust and objective metrics for quantifying walking performance during robot-assisted gait are especially relevant as it relates to dynamic stability. In this study, we assessed bi-planar dynamic stability margins for healthy adults during robot-assisted walking using EksoGT™, ReWalk™, and Indego® compared to independent overground walking at slow, self-selected, and fast speeds. Further, we examined the use of forearm crutches and its influence on dynamic gait stability margins. Methods: Kinematic data were collected at 60 Hz under several walking conditions with and without the robotic exoskeleton for six healthy controls. Outcome measures included (i) whole-body center of mass (CoM) and extrapolated CoM (XCoM), (ii) base of support (BoS), (iii) margin of stability (MoS) with respect to both feet and bilateral crutches. Results: Stability outcomes during exoskeleton-assisted walking at self-selected, comfortable walking speeds were significantly (p < 0.05) different compared to overground walking at self-selected speeds. Unlike overground walking, the control mechanisms for stability using these exoskeletons were not related to walking speed. MoSs were lower during the single support phase of gait, especially in the medial-lateral direction for all devices. MoSs relative to feet were significantly (p < 0.05) lower than those relative to crutches. The spatial location of crutches during exoskeleton-assisted walking pushed the whole-body CoM, during single support, beyond the lateral boundary of the lead foot, increasing the risk for falls if crutch slippage were to occur. Conclusion: Careful consideration of crutch placement is critical to ensuring that the margins of stability are always within the limits of the BoS to control stability and decrease fall risk.

Use of Surface EMG in Clinical Rehabilitation of Individuals With SCI: Barriers and Future Considerations.

Surface electromyography (sEMG) is a widely used technology in rehabilitation research and provides quantifiable information on the myoelectric output of a muscle. In this perspective, we discuss the barriers which have restricted the wide-spread use of sEMG in clinical rehabilitation of individuals with spinal cord injury (SCI). One of the major obstacles is integrating the time-consuming aspects of sEMG in the already demanding schedule of physical therapists, occupational therapists, and other clinicians. From the clinicians' perspective, the lack of confidence to use sEMG technology is also apparent due to their limited exposure to the sEMG technology and possibly limited mathematical foundation through educational and professional curricula. Several technical challenges include the limited technology-transfer of ever-evolving knowledge from sEMG research into the off-the-shelf EMG systems, lack of demand from the clinicians for systems with advanced features, lack of user-friendly intuitive interfaces, and the need for a multidisciplinary approach for accurate handling and interpretation of data. We also discuss the challenges in the application and interpretation of sEMG that are specific to SCI, which are characterized by non-standardized approaches in recording and interpretation of EMGs due to the physiological and structural state of the spinal cord. Addressing the current barriers will require a collaborative, interdisciplinary, and unified approach. The most relevant steps could include enhancing user-experience for students pursuing clinical education through revised curricula through sEMG-based case studies/projects, hands-on involvement in the research, and formation of a common platform for clinicians and technicians for self-education and knowledge share.