Relationship between Timed Up and Go performance and quantitative biomechanical measures of balance.

Traumatic brain injury (TBI) impairs sensory-motor functions, with debilitating consequences on postural control and balance, which persist during the chronic stages of recovery. The Timed Up and Go (TUG) test is a reliable, safe, time-efficient, and one of the most widely used clinical measures to assess gait, balance, and fall risk in TBI patients and is extensively used in inpatient and outpatient settings. Although the TUG test has been used extensively due to its ease of performance and excellent reliability, limited research has been published that investigates the relationship between TUG performance and quantitative biomechanical measures of balance. The objective of this paper was to quantify the relationship between biomechanical variables of balance and the TUG scores in individuals with chronic TBI. Regression models were constructed using six biomechanical variables to predict TUG scores. The model that conservatively removed gait speed (i.e., TUG-1/GS) gave the best results, achieving a root-mean-square error of ∼±2 s and explaining over 69% of the variability.

Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM.

Walking slowly after stroke reduces health and quality of life. This multi-site, prospective, interventional, 2-arm randomized controlled trial (NCT04121754) evaluated the safety and efficacy of an autonomous neurorehabilitation system (InTandemTM) designed to use auditory-motor entrainment to improve post-stroke walking. 87 individuals were randomized to 5-week walking interventions with InTandem or Active Control (i.e., walking without InTandem). The primary endpoints were change in walking speed, measured by the 10-meter walk test pre-vs-post each 5-week intervention, and safety, measured as the frequency of adverse events (AEs). Clinical responder rates were also compared. The trial met its primary endpoints. InTandem was associated with a 2x larger increase in speed (Δ: 0.14 ± 0.03 m/s versus Δ: 0.06 ± 0.02 m/s, F(1,49) = 6.58, p = 0.013), 3x more responders (40% versus 13%, χ2(1) ≥ 6.47, p = 0.01), and similar safety (both groups experienced the same number of AEs). The auditory-motor intervention autonomously delivered by InTandem is safe and effective in improving walking in the chronic phase of stroke.

Intensity Modulated Exoskeleton Gait Training Post Stroke.

Stroke is a leading cause of long-term disability. While major advances have been made in early intervention for the treatment of patients post stroke, the majority of survivors have residual mobility challenges. Recovery of motor function is dependent on the interrelationship between dosing, intensity, and task specific practice applied during rehabilitation. Robotic exoskeleton (RE) based gait training utilizes progressive repetitive task-oriented movements to promote functional recovery. The purpose of this investigation was to demonstrate the utilization of intensity modulated exoskeleton gait training on functional outcomes and walking speed post stoke. Preliminary data is presented for individuals diagnosed with stroke who received RE gait training. The intensity modulated RE gait training was delivered by a physical therapist and participants trained at 75-85% of calculated max heart rates at each session, over 10 weeks (30 sessions). After 10 weeks of training participants increased walking speed (10 meter walk test) and functional measures (timed up and go, berg balance assessment, dynamic gait index and functional ambulation category). These preliminary results demonstrate the utilization of intensity modulated gait training for improved functional ambulation and motor recovery using a robotic exoskeleton overground gait training post stroke.Clinical Relevance- Preliminary data provides initial evidence for intensity modulated exoskeleton gait training as a therapeutic intervention post stroke. More research is needed to demonstrate the potential relationships between intensity based gait training, exoskeletons and improved functional ambulation in post stroke rehabilitation.

Enhancing Anticipatory and Compensatory Postural Responses to Improve Balance in Individuals with TBI.

Traumatic Brain Injury (TBI) is one of the leading causes of sensorimotor deficits in adults and often results in balance impairments. Two types of postural mechanisms are employed to achieve balance during perturbations: Anticipatory Postural Adjustments (APA) and Compensatory Postural Adjustments (CPA). People with TBI have reduced APA/CPA responses due to sensory-motor deficits from the injury. The objective of this feasibility study was to evaluate a Perturbation-based Balance Training program with visual cues (PBTvc) to target both APA/CPA responses to improve balance. The evaluation included biomechanical (reactive balance during random perturbation) and functional (Berg Balance Scale, Timed Up and Go and Falls Efficacy Scale) metrics. Preliminary data is presented for two participants with chronic TBI who received 16 sessions of PBTvc. The results show an improved range of trunk oscillation and time to stability during random perturbation tasks with corresponding improvements in Berg Balance Scale, Timed Up & Go, and Falls Efficacy Scale. The results suggest that PBTvc has the potential to improve APA/CPA mechanisms for functional recovery.Clinical Relevance- Preliminary data provides initial evidence for PBTvc as a therapeutic intervention for balance rehabilitation in adults with TBI.

EEG Based Cortico-Muscular Connectivity During Standing Early Post Stroke.

In this exploratory study we studied brain activation and corticomuscular connectivity during standing in healthy individuals and persons with stroke within 40 days of cerebrovascular accident (CVA). EEG and EMG data were acquired during standing and analysis showed a trend of higher EEG power (hyper activation) in the stroke group. Direct corticomuscular connectivity between sensorimotor cortices and contralateral lower extremity muscles showed lower connectivity between affected motor, premotor, and sensory cortices, and contralateral lower extremity peripheral muscles with moderate effect size. The preliminary data in this paper suggest re-organization in left sensorimotor cortex role in controlling contralateral lower extremity muscles during standing. Correlational analysis in stroke group within 40 days of CVA showed a relationship between higher corticomuscular connectivity and better scores on balance assessments.Clinical Relevance- This study evaluates corticomuscular connectivity during standing in healthy controls and individuals with subacute stroke (within 40 days of injury). Better understanding of cortical control of standing post stroke is important to improve strategies used in mobility rehabilitation.

Motor-Cognitive Virtual Reality Training to Improve Gait and Balance in Young Adults with TBI.

Traumatic Brain Injury (TBI) is one of the leading causes of motor and cognitive deficits in adults, and often results in motor control and balance impairments. Motor deficits include gait dysfunction and decreased postural control & coordination; leading to compromised functional ambulation and reduced quality of life. Research has shown that cognitive (attention and executive) function contributes to motor deficits and recovery. Hence, targeting the motor and the cognitive domains simultaneously by increasing cognitive and motor effort to perform the task may lead to improved ambulation recovery. The objective of this investigation was to evaluate the efficacy of simultaneous motor & cognitive training (MCT) using virtual reality to improve ambulation; assessed using biomechanical, cognitive, and functional outcomes. Preliminary data is presented for three participants with chronic TBI who received MCT. The results show improved cognition, speed, endurance, step length, gait cycle time, static & reactive balance, dual-task performance, and progression towards healthy ambulation. These preliminary results suggest that integrated cognitive motor training has the potential to induce functional recovery in young adults with TBI.Clinical Relevance - Preliminary data provides initial evidence for MCT as a therapeutic intervention for gait and balance rehabilitation in young adults with TBI.

Lower extremity robotic exoskeleton devices for overground ambulation recovery in acquired brain injury-A review.

Acquired brain injury (ABI) is a leading cause of ambulation deficits in the United States every year. ABI (stroke, traumatic brain injury and cerebral palsy) results in ambulation deficits with residual gait and balance deviations persisting even after 1 year. Current research is focused on evaluating the effect of robotic exoskeleton devices (RD) for overground gait and balance training. In order to understand the device effectiveness on neuroplasticity, it is important to understand RD effectiveness in the context of both downstream (functional, biomechanical and physiological) and upstream (cortical) metrics. The review identifies gaps in research areas and suggests recommendations for future research. We carefully delineate between the preliminary studies and randomized clinical trials in the interpretation of existing evidence. We present a comprehensive review of the clinical and pre-clinical research that evaluated therapeutic effects of RDs using various domains, diagnosis and stage of recovery.

Evaluation of Changes in Kinematic Measures of Three Dimensional Reach to Grasp Movements in the Early Subacute Period of Recovery from Stroke.

This study examines longitudinal data of subjects initially examined in the early subacute period of recovery following a stroke with a test of reach to grasp (RTG) kinematics in an attempt to identify changes in movement patterns during the period of heightened neural recovery following a stroke. Subjects (n=8) were a convenience sample of persons with stroke that participated in an intervention trial. Baseline Upper Extremity Fugl Meyer Assessment (UEFMA) scores ranged between 31 and 52 and ages were between 49 and 83. The UEFMA and RTG test were collected prior to intervention, immediately after the intervention (approximately 18 days later post baseline) and one month after the intervention. RTG data for the uninvolved UE was collected at the one-month session. Subjects reached for objects placed on a table 10 cm from their sternums, picking them up and placing them on a target 30 cm from their acromioclavicular joints. Data was collected using an optical motion capture system. Active makers were placed on each fingertip, metacarpophalangeal, and proximal interphalangeal joint. Four additional passive markers were placed on the dorsum of the hand, the elbow, the shoulder, and the sternum. Subjects demonstrated statistically significant improvements in reaching duration, reaching trajectory smoothness, time after peak velocity and peak grip aperture. All of these measures correlated significantly with improvements in UEFMA. Clinical Relevance- Kinematic measures of reaching and grasping collected early in the subacute period of recovery from stroke may offer insight into specific aspects of the recovery of upper extremity motor function that differ from the information gleaned from clinical scales.

Changes in Center of Pressure after Robotic Exoskeleton Gait Training in Adults with Acquired Brain Injury.

Acquired brain injury (ABI) resulting in hemiplegia, is one of the leading causes of gait and balance deficits in adults. Gait and balance deficits include reduced momentum for forward progression, reduced step length, increased spatial and temporal asymmetry, and decreased speed; resulting in reduced functional ambulation, activities of daily living, and quality of life. Wearable lower extremity robotic exoskeletons (REs) are becoming an effective method for gait neurorehabilitation in individuals with ABI. REs can provide high dose, consistent, goal-directed repetition of movements as well as balance & stability for individuals with ABI. The objective of this study is to understand the effect of RE gait training using center of pressure (COP) displacement, temporal & spatial parameters, and functional outcomes for individuals with ABI. The results from this investigation show improved anterior-posterior COP displacement & rate of progression, spatial symmetry, step length, walking speed, and decreased time during the gait cycle. These preliminary results suggest that high dose, repetitive gait training using robotic exoskeletons has the potential to induce recovery of function in adults diagnosed with ABI.

Utilization of Robotic Exoskeleton for Overground Walking in Acute and Chronic Stroke.

Stroke commonly results in gait deficits which impacts functional ambulation and quality of life. Robotic exoskeletons (RE) for overground walking are devices that are programmable to provide high dose and movement-impairment specific assistance thus offering new rehabilitation possibilities for recovery progression in individuals post stroke. The purpose of this investigation is to present preliminary utilization data in individuals with acute and chronic stroke after walking overground with an RE. Secondary analysis on a subset of individuals is presented to understand the mechanistic changes due to RE overground walking. Thirty-eight participants with hemiplegia secondary to stroke were enrolled in a clinical trial conducted at eight rehabilitation centers. Data is presented for four sessions of overground walking in the RE over the course of 2 weeks. Participants continued their standard of care if they had any ongoing therapy at the time of study enrollment. Gait speed during the 10 Meter Walk Test, Gait deviations and the Functional Ambulation Category (FAC) data were collected before (baseline) and after (follow-up) the RE walking sessions. Walking speed significantly increased between baseline and follow-up for participants in the chronic (p <0.01) and acute (p < 0.05) stage of stroke recovery. FAC level significantly improved (p < 0.05) and there were significantly fewer (p < 0.05) gait deviations observed for participants in the acute stages of stroke recovery between baseline and follow-up. Secondary analysis on a subset of eight participants indicated that after four sessions of overground walking with the RE, the participants significantly improved their spatial symmetry. The walk time, step count and ratio of walk time to up time increased from first session to the last session for participants in the chronic and acute stages of stroke. The RE was effectively utilized for overground walking for individuals with acute and chronic stroke with varying severity levels. The results demonstrated an increase in walking speed, improvement in FAC and a decrease in gait deviations (from baseline to follow-up) after four sessions of overground walking in the RE for participants. In addition, preliminary data indicated that spatial symmetry and step length also improved after utilization of an RE for overground walking.

Effect of robotic exoskeleton gait training during acute stroke on functional ambulation.

BACKGROUND: Stroke is a leading cause of disability resulting in long-term functional ambulation deficits. Conventional therapy can improve ambulation, but may not be able to provide consistent, high dose repetition of movement, resulting in variable recovery with residual gait deviations. OBJECTIVE: The objective of this preliminary prospective investigation is to evaluate the ability of a robotic exoskeleton (RE) to provide high dose gait training, and measure the resulting therapeutic effect on functional ambulation in adults with acute stroke. METHODS: Participants (n = 14) received standard of care (SOC) and RE overground gait training during their scheduled physical therapy (PT) sessions at the same inpatient rehabilitation facility. The outcome measures included distance walked during their PT training sessions (RE and SOC), and functional ambulation measures (10-meter walk test (10MWT), 6-minute walk test (6 MWT), and timed up and go (TUG)). RESULTS: The average total distance walked during RE and the average distance per RE session was significantly higher than SOC sessions. Total walking distance during PT (RE+SOC) showed a strong positive correlation to the total number of steps during RE sessions and number of RE sessions. All functional ambulation measures showed significant improvement at follow-up compared to baseline. The improvement in functional ambulation measures showed a positive correlation with the increase in number of RE gait training sessions. CONCLUSION: The RE can be utilized for inpatient rehabilitation in conjunction with SOC gait training sessions and may result in improved functional ambulation in adults with acute stroke. This preliminary research provides information on the ability of the robotic exoskeleton to provide high dose therapy and its therapeutic effect on functional ambulation in adults with acute stroke during inpatient rehabilitation.

Enhancing sensory acuity and balance function using near-sensory biofeedback-based perturbation intervention for individuals with traumatic brain injury.

BACGROUND: Interventions addressing balance dysfunction after traumatic brain injury (TBI) only target compensatory aspects and do not investigate perceptual mechanisms such as sensory acuity. OBJECTIVE: To evaluate the efficacy of a novel intervention that integrates sensory acuity with a perturbation-based approach for improving the perception and functional balance after TBI. METHODS: A two-group design was implemented to evaluate the effect of a novel, perturbation-based balance intervention. The intervention group (n = 5) performed the intervention with the sinusoidal (0.33, 0.5, and 1 Hz) perturbations to the base of support with amplitudes derived using our novel outcome of sensory acuity - perturbation perception threshold (PPT). The efficacy is evaluated using changes in PPT and functional outcomes (Berg Balance Scale (BBS), Timed-up and Go (TUG), 5-meter walk test (5MWT), and 10-meter walk test (10MWT)). RESULTS: There was a significant post-intervention change in PPT for 0.33 Hz (p = 0.021). Additionally, clinically and statistically significant improvements in TUG (p = 0.03), 5MWT (p = 0.05), and 10MWT (p = 0.04) were observed. CONCLUSIONS: This study provides preliminary efficacy of a novel, near-sensory balance intervention for individuals with TBI. The use of PPT is suggested for a comprehensive understanding and treatment of balance dysfunction. The promising results support the investigation in a larger cohort.

Augmented-reality guided treadmill training as a modality to improve functional mobility post-stroke: A proof-of-concept case series.

Objective: To provide a proof-of-concept for a novel stroke-gait-specific augmented reality (AR)-guided treadmill intervention by evaluating its effect on temporospatial and functional outcomes of mobility.Methods: Two females with hemiplegia post stroke were recruited for participation in a 4-week intervention, and a single healthy control was recruited for baseline comparisons. The stroke-intervention (SI) participant (aged 54-years), completed 12 sessions of AR-guided treadmill intervention. The stroke-control (SC) participant (aged 59-years) completed 12 sessions of conventional treadmill intervention. Temporospatial and functional mobility were assessed pre-intervention, post-intervention, and at 1-month follow-up. Physical ACtivity Enjoyment Scale (PACES) was administered post-intervention.Results: The SI participant showed clinically meaningful improvements in functional outcomes post-intervention and at 1-month follow-up (Berg balance score (BBS): +6 and +10 points; Dynamic Gait Index (DGI): +2 at post-intervention only; walking speed: +0.19 and +0.24 m/s; 6-minute walk test (6MWT): +51.9 and +38.9) respectively. The SC showed clinically meaningful improvements in BBS (+3 and +3) and walking speed (+0.06 at post-intervention). The PACES scores showed that the SI participant had a significantly higher (23 points) enjoyment level during the intervention compared to the SC participant. The SI participant was more asymmetric compared to the SC participant at pre and post-intervention visits.Conclusions: The SI participant showed greater improvement in functional assessments compared to the SC participant post intervention. The AR-guided approach may have added benefits compared to traditional treadmill training, while providing better customization, patient enjoyment, and engagement. Further investigation with a larger sample is warranted.

Hand Focused Upper Extremity Rehabilitation in the Subacute Phase Post-stroke Using Interactive Virtual Environments.

Introduction: Innovative motor therapies have attempted to reduce upper extremity impairment after stroke but have not made substantial improvement as over 50% of people post-stroke continue to have sensorimotor deficits affecting their self-care and participation in daily activities. Intervention studies have focused on the role of increased dosing, however recent studies have indicated that timing of rehabilitation interventions may be as important as dosing and importantly, that dosing and timing interact in mediating effectiveness. This study is designed to empirically test dosing and timing. Methods and Analysis: In this single-blinded, interventional study, subjects will be stratified on two dimensions, impairment level (Fugl-Meyer Upper Extremity Assessment (FM) and presence or absence of Motor Evoked Potentials (MEPs) as follows; (1) Severe, FM score 10-19, MEP+, (2) Severe, FM score 10-19, MEP-, (3) Moderate, FM score 20-49, MEP+, (4) Moderate, FM score 20-49, MEP-. Subjects not eligible for TMS will be assigned to either group 2 (if severe) or group 3 (if moderate). Stratified block randomization will then be used to achieve a balanced assignment. Early Robotic/VR Therapy (EVR) experimental group will receive in-patient usual care therapy plus an extra 10 h of intensive upper extremity therapy focusing on the hand using robotically facilitated rehabilitation interventions presented in virtual environments and initiated 5-30 days post-stroke. Delayed Robotic/VR Therapy (DVR) experimental group will receive the same intervention but initiated 30-60 days post-stroke. Dose-matched usual care group (DMUC) will receive an extra 10 h of usual care initiated 5-30 days post-stroke. Usual Care Group (UC) will receive the usual amount of physical/occupational therapy. Outcomes: There are clinical, neurophysiological, and kinematic/kinetic measures, plus measures of daily arm use and quality of life. Primary outcome is the Action Research Arm Test (ARAT) measured at 4 months post-stroke. Discussion: Outcome measures will be assessed to determine whether there is an early time period in which rehabilitation will be most effective, and whether there is a difference in the recapture of premorbid patterns of movement vs. the development of an efficient, but compensatory movement strategy. Ethical Considerations: The IRBs of New Jersey Institute of Technology, Rutgers University, Northeastern University, and Kessler Foundation reviewed and approved all study protocols. Study was registered in https://ClinicalTrials.gov (NCT03569059) prior to recruitment. Dissemination will include submission to peer-reviewed journals and professional presentations.

Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation.

Stroke is the leading cause of severe disability in adults resulting in mobility, balance, and coordination deficits. Robotic exoskeletons (REs) for stroke rehabilitation can provide the user with consistent, high dose repetition of movement, as well as balance and stability. The goal of this intervention study is to evaluate the ability of a RE to provide high dose gait therapy and the resulting effect on functional recovery for individuals with acute stroke. The investigation included a total of 44 participants. Twenty-two participants received RE gait training during inpatient rehabilitation (RE+SOC Group), and a matched sample of 22 individuals admitted to the same inpatient rehabilitation facility-receiving conventional standard of care treatment (SOC group). The effect of RE training was quantified using total distance walked during inpatient rehabilitation and functional independence measure (FIM). The total distance walked during inpatient rehabilitation showed a significant difference between the SOC and RE+SOC groups. RE+SOC walked twice the distance as SOC during the same duration (time spent in inpatient rehabilitation) of training. In addition, the average change in motor FIM showed a significant difference between the SOC and RE+SOC groups, where the average difference in motor FIM was higher in RE+SOC compared to the SOC group. The results suggest that RE provided increased dosing of gait training without increasing the duration of training during acute stroke rehabilitation. The RE+SOC group increased their motor FIM score (change from admission to discharge) compared to SOC group, both groups were matched for admission motor FIM scores suggesting that increased dosing may have improved motor function.

Kinetic Gait Changes after Robotic Exoskeleton Training in Adolescents and Young Adults with Acquired Brain Injury.

BACKGROUND: Acquired brain injury (ABI) is one of the leading causes of motor deficits in children and adults and often results in motor control and balance impairments. Motor deficits include abnormal loading and unloading, increased double support time, decreased walking speed, control, and coordination. These deficits lead to diminished functional ambulation and reduced quality of life. Robotic exoskeletons (RE) for motor rehabilitation can provide the user with consistent, symmetrical, goal-directed repetition of movement, as well as balance and stability. PURPOSE: The goal of this preliminary prospective before and after study is to evaluate the therapeutic effect of RE training on the loading/unloading and spatial-temporal characteristics in adolescents and young adults with chronic ABI. METHOD: Seven participants diagnosed with ABI between the ages of 14 and 27 years participated in the study. All participants received twelve 45 minute sessions of RE gait training. The bilateral loading (linearity of loading and rate of loading), speed, step length, swing time, stance time, and total time were collected using Zeno™ walkway (ProtoKinetics, Havertown, PA, USA) before and after RE training. RESULTS: Results from the study showed improved step length, speed, and an overall progression towards healthy bilateral loading, with linearity of loading showing a significant therapeutic effect (p < 0.05). CONCLUSION: These preliminary results suggest that high dose, repetitive, consistent gait training using RE has the potential to induce recovery of function in adolescents and young adults diagnosed with ABI.

Alterations in Cortical Activity due to Robotic Gait Training in Traumatic Brain Injury.

Traumatic brain injury (TBI), is one of the leading causes of motor deficits in children and adults, affecting motor control, coordination, and acuity. This results in reduced functional ambulation and quality of life. Robotic exoskeletons (REs) are quickly becoming an effective method for gait neurorehabilitation in individuals with TBI. Neurorehabilitation is based on the principle that the human brain is capable of reorganization due to high dose motor training. Understanding the underlying mechanisms of cortical reorganization will help improve current rehabilitation. The objective of the study is to understand the cortical activity differences due to RE training and recovery of functional ambulation for individuals with chronic TBI, using functional near-infrared spectroscopy. There was an increase in cortical activation in the prefrontal cortex (PFC), bilateral premotor cortex (PMC) and motor cortex (M1) while walking with RE versus without RE at follow-up. Furthermore, decreased activation was observed in PFC, bilateral PMC and M1 from baseline to follow-up while walking without RE with a corresponding improvement in functional ambulation. These preliminary results for one participant provide initial evidence to understand the cortical mechanisms during RE gait training and the recovery induced due to the training.

Evaluating Sensory Acuity as a Marker of Balance Dysfunction After a Traumatic Brain Injury: A Psychophysical Approach.

There is limited research on sensory acuity i.e., ability to perceive external perturbations via body-sway during standing in individuals with a traumatic brain injury (TBI). It is unclear whether sensory acuity diminishes after a TBI and if it is a contributing factor to balance dysfunction. The objective of this investigation is to first objectively quantify the sensory acuity in terms of perturbation perception threshold (PPT) and determine if it is related to functional outcomes of static and dynamic balance. Ten individuals with chronic TBI and 11 age-matched healthy controls (HC) performed PPT assessments at 0.33, 0.5, and 1 Hz horizontal perturbations to the base of support in the anterior-posterior direction, and a battery of functional assessments of static and dynamic balance and mobility [Berg balance scale (BBS), timed-up and go (TUG) and 5-m (5MWT) and 10-m walk test (10MWT)]. A psychophysical approach based on Single Interval Adjustment Matrix Protocol (SIAM), i.e., a yes-no task, was used to quantify the multi-sensory thresholds of perceived external perturbations to calculate PPT. A mixed-design analysis of variance (ANOVA) and post-hoc analyses were performed using independent and paired t-tests to evaluate within and between-group differences. Pearson correlation was computed to determine the relationship between the PPT and functional measures. The PPT values were significantly higher for the TBI group (0.33 Hz: 2.97 ± 1.0, 0.5 Hz: 2.39 ± 0.7, 1 Hz: 1.22 ± 0.4) compared to the HC group (0.33 Hz: 1.03 ± 0.6, 0.5 Hz: 0.89 ± 0.4, 1 Hz: 0.42 ± 0.2) for all three perturbation frequencies (p < 0.006 post Bonferroni correction). For the TBI group, the PPT for 1 Hz perturbations showed significant correlation with the functional measures of balance (BBS: r = -0.66, p = 0.037; TUG: r = 0.78, p = 0.008; 5MWT: r = 0.67, p = 0.034, 10MWT: r = 0.76, p = 0.012). These findings demonstrate that individuals with TBI have diminished sensory acuity during standing which may be linked to impaired balance function after TBI.

The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation.

BACKGROUND: Atypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation. METHODS: A multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds with and without the device was conducted prior to and following the five training visits. RESULTS: All 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P's < 0.05). CONCLUSIONS: When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking. TRIAL REGISTRATION: NCT03499210. Prospectively registered on March 28, 2018.

Kinematic and Functional Gait Changes After the Utilization of a Foot Drop Stimulator in Pediatrics.

Foot drop is one of the most common secondary conditions associated with hemiplegia post stroke and cerebral palsy (CP) in children, and is characterized by the inability to lift the foot (dorsiflexion) about the ankle. This investigation focuses on children and adolescents diagnosed with brain injury and aims to evaluate the orthotic and therapeutic effects due to continuous use of a foot drop stimulator (FDS). Seven children (10 ± 3.89 years) with foot drop and hemiplegia secondary to brain injury (stroke or CP) were evaluated at baseline and after 3 months of FDS usage during community ambulation. Primary outcome measures included using mechanistic (joint kinematics, toe displacement, temporal-spatial asymmetry), and functional gait parameters (speed, step length, time) to evaluate the orthotic and therapeutic effects. There was a significant correlation between spatial asymmetry and speed without FDS at 3 months (r = 0.76, p < 0.05, df = 5) and no correlation between temporal asymmetry and speed for all conditions. The results show orthotic effects including significant increase in toe displacement (p < 0.025 N = 7) during the swing phase of gait while using the FDS. A positive correlation exists between toe displacement and speed (with FDS at 3 months: r = 0.62, p > 0.05, without FDS at 3 months: r = 0.44, p > 0.05). The results indicate an orthotic effect of increased dorsiflexion and toe displacement during swing with the use of the FDS in children with hemiplegia. Further, the study suggests that there could be a potential long-term effect of increased dorsiflexion during swing with continuous use of FDS.