Study design: Clinical trial. Objective: To demonstrate that a 12-week exoskeleton-based robotic gait training regimen can lead to a clinically meaningful improvement in independent gait speed, in community-dwelling participants with chronic incomplete spinal cord injury (iSCI). Setting: Outpatient rehabilitation or research institute. Methods: Multi-site (United States), randomized, controlled trial, comparing exoskeleton gait training (12 weeks, 36 sessions) with standard gait training or no gait training (2:2:1 randomization) in chronic iSCI (>1 year post injury, AIS-C, and D), with residual stepping ability. The primary outcome measure was change in robot-independent gait speed (10-meter walk test, 10MWT) post 12-week intervention. Secondary outcomes included: Timed-Up-and-Go (TUG), 6-min walk test (6MWT), Walking Index for Spinal Cord Injury (WISCI-II) (assistance and devices), and treating therapist NASA-Task Load Index. Results: Twenty-five participants completed the assessments and training as assigned (9 Ekso, 10 Active Control, 6 Passive Control). Mean change in gait speed at the primary endpoint was not statistically significant. The proportion of participants with improvement in clinical ambulation category from home to community speed post-intervention was greatest in the Ekso group (>1/2 Ekso, 1/3 Active Control, 0 Passive Control, p < 0.05). Improvements in secondary outcome measures were not significant. Conclusions: Twelve weeks of exoskeleton robotic training in chronic SCI participants with independent stepping ability at baseline can improve clinical ambulatory status. Improvements in raw gait speed were not statistically significant at the group level, which may guide future trials for participant inclusion criteria. While generally safe and tolerable, larger gains in ambulation might be associated with higher risk for non-serious adverse events.

Major depressive disorder (MDD) has shown to negatively impact physical recovery in a variety of medical events (e.g., stroke and spinal cord injuries). Yet depression assessments, which are typically subjective in nature, are seldom considered to develop or guide rehabilitation strategies. The present study developed a predictive depression assessment technique using functional near-infrared spectroscopy (fNIRS) that can be rapidly integrated or performed concurrently with existing physical rehabilitation tasks. Thirty-one volunteers, including 14 adults clinically diagnosed with MDD and 17 healthy adults, participated in the study. Brain oxyhemodynamic (HbO) responses were recorded using a 16-channel wearable continuous-wave fNIRS device while the volunteers performed the Grasp and Release Test in four 16-minute blocks. Ten features, extracted from HbO signals, from each channel served as inputs to XGBoost and Random Forest algorithms developed for each block and combination of successive blocks. Top 5 common features resulted in a classification accuracy of 92.6%, sensitivity of 84.8%, and specificity of 91.7% using the XGBoost classifier. This study identified mean HbO, full width half maximum and kurtosis, as specific neuromarkers, for predicting MDD across specific depression-related regions of interests (i.e., dorsolateral and ventrolateral prefrontal cortex). Our results suggest that a wearable fNIRS head probe monitoring specific brain regions, and limiting extraction to few features, can enable quick setup and rapid assessment of depression in patients. The overarching goal is to embed predictive neurotechnology during post-stroke and post-spinalcord-injury rehabilitation sessions to monitor patients’ depression symptomology so as to actively guide decisions about motor therapies.

Objective. Powered exoskeletons have been used to help persons with gait impairment regain some walking ability. However, little is known about its impact on neuromuscular coordination in persons with stroke. The objective of this study is to investigate how a powered exoskeleton could affect the neuromuscular coordination of persons with post-stroke hemiparesis. Approach. Eleven able-bodied subjects and ten stroke subjects participated in a single-visit treadmill walking assessment, in which their motion and lower-limb muscle activities were captured. By comparing spatiotemporal parameters, kinematics, and muscle synergy pattern between two groups, we characterized the normal gait pattern and the post-stroke motor deficits. Five eligible stroke subjects received exoskeleton-assisted gait trainings and walking assessments were conducted pre-intervention (Pre) and post-intervention (Post), without (WO) and with (WT) the exoskeleton. We compared their gait performance between (a) Pre and Post to investigate the effect of exoskeleton-assisted gait training and, (b) WO and WT the exoskeleton to investigate the effect of exoskeleton wearing on stroke subjects. Main results. While four distinct motor modules were needed to describe lower-extremity activities during stead-speed walking among able-bodied subjects, three modules were sufficient for the paretic leg from the stroke subjects. Muscle coordination complexity, module composition and activation timing were preserved after the training, indicating the intervention did not significantly change the neuromuscular coordination. In contrast, walking WT the exoskeleton altered the stroke subjects’ synergy pattern, especially on the paretic side. The changes were dominated by the activation profile modulation towards the normal pattern observed from the able-bodied group. Significance. This study gave us some critical insight into how a powered exoskeleton affects the stroke subjects’ neuromuscular coordination during gait and demonstrated the potential to use muscle synergy as a method to evaluate the effect of the exoskeleton training. This study was registered at ClinicalTrials.gov (identifier: NCT03057652).

Robotic wearable exoskeletons have been utilized as a gait training device in persons with spinal cord injury. This pilot study investigated the feasibility of offering exoskeleton-assisted gait training (EGT) on gait in individuals with incomplete spinal cord injury (iSCI) in preparation for a phase III RCT. The objective was to assess treatment reliability and potential efficacy of EGT and conventional physical therapy (CPT). Forty-four individuals were screened, and 13 were eligible to participate in the study. Nine participants consented and were randomly assigned to receive either EGT or CPT with focus on gait. Subjects received EGT or CPT, five sessions a week (1 h/session daily) for 3 weeks. American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS), 10-Meter Walk Test (10MWT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG) test, and gait characteristics including stride and step length, cadence and stance, and swing phase durations were assessed at the pre- and immediate post- training. Mean difference estimates with 95% confidence intervals were used to analyze the differences. After training, improvement was observed in the 6MWT for the EGT group. The CPT group showed significant improvement in the TUG test. Both the EGT and the CPT groups showed significant increase in the right step length. EGT group also showed improvement in the stride length. EGT could be applied to individuals with iSCI to facilitate gait recovery. The subjects were able to tolerate the treatment; however, exoskeleton size range may be a limiting factor in recruiting larger cohort of patients. Future studies with larger sample size are needed to investigate the effectiveness and efficacy of exoskeleton-assisted gait training as single gait training and combined with other gait training strategies. Clinicaltrials.org, NCT03011099 , retrospectively registered on January 3, 2017.

Objective: Gait deficit after multiple sclerosis (MS) can be characterized by altered muscle activation patterns. There is preliminary evidence of improved walking with a lower limb exoskeleton in persons with MS. However, the effects of exoskeleton-assisted walking on neuromuscular modifications are relatively unclear. The objective of this study was to investigate the muscle synergies, their activation patterns and the differences in neural strategies during walking with (EXO) and without (No-EXO) an exoskeleton. Methods: Ten subjects with MS performed walking during EXO and No-EXO conditions. Electromyography signals from seven leg muscles were recorded. Muscle synergies and the activation profiles were extracted using non-negative matrix factorization. Results: The stance phase duration was significantly shorter during EXO compared to the No-EXO condition (p<0.05). Moreover, typically 3-5 modules were extracted in each condition. The module-1 (comprising Vastus Medialis and Rectus Femoris muscles), module-2 (comprising Soleus and Medial Gastrocnemius muscles), module-3 (Tibialis Anterior muscle) and module-4 (comprising Biceps Femoris and Semitendinosus muscles) were comparable between conditions. During EXO condition, Semitendinosus and Vastus Medialis emerged in module-5 in 7/10 subjects. Compared to No-EXO, average activation amplitude was significantly reduced corresponding to module-2 during the stance phase and module-3 during the swing phase during EXO. Conclusion: Exoskeleton-assistance does not alter the existing synergy modules, but could induce a new module to emerge, and alters the control of these modules, i.e., modifies the neural commands indicated by the reduced amplitude of the activation profiles. Significance: The work provides insights on the potential underlying mechanism of improving gait functions after exoskeleton-assisted locomotor training.