Efficacy of Robot-Assisted Gait Training Combined with Robotic Balance Training in Subacute Stroke Patients: A Randomized Clinical Trial.

Recently, the use of robotic technology in gait and balance rehabilitation of stroke patients has been introduced, with positive results. The purpose of this study was to evaluate the effectiveness of robotic gait and trunk rehabilitation compared to robotic gait training alone on balance, activities, and participation measures in patients with subacute stroke. The study was a randomized, controlled, single blind, parallel group clinical trial. Thirty-six patients with first ischemic or hemorrhagic stroke event were enrolled, and they were randomized in two groups: Gait Group (GG), where they received only robotic treatment for gait rehabilitation through an end-effector system, and Gait/Trunk Group (GTG) where they performed end-effector gait rehabilitation and balance with a robotic platform, 3 times/week for 12 sessions/month. At the end of the study, there was an improvement in balance ability in both groups. Instead, the lower limb muscle strength and muscle tone significantly improved only in the GTG group, where we found a significant reduction in the trunk oscillations and displacement during dynamic exercises more than the GG group. The robotic platform which was added to the gait robotic treatment offers more intense and controlled training of the trunk that positively influences the tone and strength of lower limb muscles.

COVID-19 and hospital restrictions: physical disconnection and digital re-connection in disorders of consciousness.

Purpose: The coronavirus disease 2019 (COVID-19) pandemic forced hospitals to adopt tighter restrictions, the most impacting is no access to visitors. Disorder of consciousness (DOC) due to severe acquired brain injury is a condition needing neurorehabilitation and the role of relatives is essential, hence besides physical "disconnection" digital "re-connection" is crucial. We aimed to assess whether digital communication benefits in patients with DOC, considering the sensorial and emotional deprivation due to the COVID-19 emergency lock-down.Methods: For eleven consecutive patients with DOC admitted to our Intensive Neurorehabilitation Care (mean age: 45; females: 9), two observers registered neurobehavioral changes during a video-calls with their relatives. Heart-rate variability was measured before and during the calls. The video-call was performed by using two displays of different sizes: tablet (T-video-call) and large screen (LS-Video-call).Results: The video-calls impacted on the patients' vigilance and in the relationship with relatives. Moreover, positively impacted on their relatives. The current results showed significant greater impact on patients during the LS-video-call than when they are exposed to T-video-call.Conclusions: During the COVID-19 pandemic, besides the physical disconnection to stop the contagion spread, a "digital re-connection" is needed for all and especially for fragile population groups as patients with DOC.

Efficacy of electrical stimulation of denervated muscle: A multicenter, double-blind, randomized clinical trial.

BACKGROUND: This was a multicenter, double-blind, randomized clinical trial to investigate the efficacy of electrical stimulation of denervated muscle (ESDM) on recovery of patients with peripheral nerve injuries. METHODS: We enrolled 38 patients with traumatic peripheral nerve injuries with axonal damage and clinical impairment of two muscles, who were randomly treated with real or sham electrical stimulation (ES). Clinical and neurophysiological examinations were performed before treatment, at the end of treatment, and 3 mo posttreatment, by the same physician who was blinded to the ES allocation. RESULTS: All patients improved but there was no significant beneficial effect of ESDM compared with sham treatment. CONCLUSIONS: This study failed to demonstrate the efficacy of ESDM for peripheral nerve injuries. However, given the large number of variables related to ES and the heterogeneity in disease etiologies and clinical manifestations, future studies on homogeneous populations using different stimulation protocols may be useful.

Ultrasound evaluation of pupil: secrets of the "black hole" unveiled.

This Letter to the Editor is in response to Stevens and colleagues, who presented a study about pupillometry in patients with traumatic brain injury. They did not find any correlation between pupil diameter and intracranial pressure. We agree with the clinical importance of pupil assessment and we would like to suggest the application of transorbital ultrasound for this evaluation. This approach has been proposed in the past and, with our work, we show the possible quantification of symmetry of pupil diameter variation in response to a stimulus. This approach may represent a proficient and safe method for patients' supervision.

Reliability, validity and discriminant ability of a robotic device for finger training in patients with subacute stroke.

BACKGROUND: The majority of stroke survivors experiences significant hand impairments, as weakness and spasticity, with a severe impact on the activity of daily living. To objectively evaluate hand deficits, quantitative measures are needed. The aim of this study is to assess the reliability, the validity and the discriminant ability of the instrumental measures provided by a robotic device for hand rehabilitation, in a sample of patients with subacute stroke. MATERIAL AND METHODS: In this study, 120 patients with stroke and 40 controls were enrolled. Clinical evaluation included finger flexion and extension strength (using the Medical Research Council, MRC), finger spasticity (using the Modified Ashworth Scale, MAS) and motor control and dexterity during ADL performance (by means of the Frenchay Arm Test, FAT). Robotic evaluations included finger flexion and extension strength, muscle tone at rest, and instrumented MAS and Modified Tardieu Scale. Subjects were evaluated twice, one day apart, to assess the test-retest reliability of the robotic measures, using the Intraclass Correlation Coefficient (ICC). To estimate the response stability, the standard errors of measurement and the minimum detectable change (MDC) were also calculated. Validity was assessed by analyzing the correlations between the robotic metrics and the clinical scales, using the Spearman's Correlation Coefficient (r). Finally, we investigated the ability of the robotic measures to distinguish between patients with stroke and healthy subjects, by means of Mann-Whitney U tests. RESULTS: All the investigated measures were able to discriminate patients with stroke from healthy subjects (p < 0.001). Test-retest reliability was found to be excellent for finger strength (in both flexion and extension) and muscle tone, with ICCs higher than 0.9. MDCs were equal to 10.6 N for finger flexion, 3.4 N for finger extension, and 14.3 N for muscle tone. Conversely, test-retest reliability of the spasticity measures was poor. Finally, finger strength (in both flexion and extension) was correlated with the clinical scales (r of about 0.7 with MRC, and about 0.5 with FAT). DISCUSSION: Finger strength (in both flexion and extension) and muscle tone, as provided by a robotic device for hand rehabilitation, are reliable and sensitive measures. Moreover, finger strength is strongly correlated with clinical scales. Changes higher than the obtained MDC in these robotic measures could be considered as clinically relevant and used to assess the effect of a rehabilitation treatment in patients with subacute stroke.

Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial.

BACKGROUND AND PURPOSE: After stroke, only 12% of survivors obtain complete upper limb (UL) functional recovery, while in 30% to 60% UL deficits persist. Despite the complexity of the UL, prior robot-mediated therapy research has used only one robot in comparisons to conventional therapy. We evaluated the efficacy of robotic UL treatment using a set of 4 devices, compared with conventional therapy. METHODS: In a multicenter, randomized controlled trial, 247 subjects with subacute stroke were assigned either to robotic (using a set of 4 devices) or to conventional treatment, each consisting of 30 sessions. Subjects were evaluated before and after treatment, with follow-up assessment after 3 months. The primary outcome measure was change from baseline in the Fugl-Meyer Assessment (FMA) score. Secondary outcome measures were selected to assess motor function, activities, and participation. RESULTS: One hundred ninety subjects completed the posttreatment assessment, with a subset (n = 122) returning for follow-up evaluation. Mean FMA score improvement in the robotic group was 8.50 (confidence interval: 6.82 to 10.17), versus 8.57 (confidence interval: 6.97 to 10.18) in the conventional group, with no significant between-groups difference (adjusted mean difference -0.08, P = 0.948). Both groups also had similar change in secondary measures, except for the Motricity Index, with better results for the robotic group (adjusted mean difference 4.42, P = 0.037). At follow-up, subjects continued to improve with no between-groups differences. DISCUSSION AND CONCLUSIONS: Robotic treatment using a set of 4 devices significantly improved UL motor function, activities, and participation in subjects with subacute stroke to the same extent as a similar amount of conventional therapy. Video Abstract is available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A291).

Efficacy of end-effector Robot-Assisted Gait Training in subacute stroke patients: Clinical and gait outcomes from a pilot bi-centre study.

BACKGROUND: End-effector robots allow intensive gait training in stroke subjects and promote a successful rehabilitation. A comparison between conventional and end-effector Robot-Assisted Gait Training (RAGT) in subacute stroke patients is needed. OBJECTIVE: To investigate the efficacy of end-effector RAGT in subacute stroke patients. METHODS: Twenty-six subacute stroke patients were divided into two group: 14 patients performed RAGT (RG); 12 patients performed conventional gait training (CG). Clinical assessment and gait analysis were performed at the beginning (T0) and at the end (T1) of the rehabilitation. RESULTS: The RG revealed a significant improvement in body function, activities, participation scales, and in the distance measured with the 6 MWT. The affected lower limb's spasticity significantly decreased at T1. In gait analysis, RG showed significantly increases in many parameters. The CG significantly improved clinical assessments but showed no significant changes in gait parameters. Statistically significant differences between RG and CG were found in MRC-HE, TCT, 10 MWT, 6 MWT, and TUG. No significant difference between groups was registered in gait kinematics. CONCLUSIONS: Both rehabilitation treatments produce promising effects in subacute stroke patients. RAGT device offers a more intensive, controlled, and physiological gait training and significantly improved deambulation.

Reliability, validity and discriminant ability of the instrumental indices provided by a novel planar robotic device for upper limb rehabilitation.

BACKGROUND: In the last few years, there has been an increasing interest in the use of robotic devices to objectively quantify motor performance of patients after brain damage. Although these robot-derived measures can potentially add meaningful information about the patient's dexterity, as well as be used as outcome measurements after the rehabilitation treatment, they need to be validated before being used in clinical practice. The present work aims to evaluate the reliability, the validity and the discriminant ability of the metrics provided by a novel robotic device for upper limb rehabilitation. METHODS: Forty-eight patients with sub-acute stroke and 40 age-matched healthy subjects were involved in this study. Clinical evaluation included: Fugl-Meyer Assessment for the upper limb, Action Research Arm Test, and Barthel Index. Robotic evaluation of the upper limb performance consisted of 14 measures of motor ability quantifying the dexterity in performing planar reaching movements. Patients were evaluated twice, one day apart, to assess the reliability of the robotic metrics, using the Intraclass Correlation Coefficient. Validity was assessed by analyzing the correlation of the robotic metrics with the clinical scales, by means of the Spearman's Correlation Coefficient. Finally, the ability of the robotic metrics to distinguish between patients with stroke and healthy subjects was investigated with t-tests and the Effect Size. RESULTS: Reliability was found to be excellent for 12 measures and from moderate to good for the remaining 2. Most of the robotic indices were strongly correlated with the clinical scales, while a few showed a moderate correlation and only one was not correlated with the Barthel Index and weakly correlated with the remain two. Finally, all but one the provided metrics were able to discriminate between the two groups, with large effect sizes for most of them. CONCLUSION: We found that all the robotic indices except one provided by a novel robotic device for upper limb rehabilitation are reliable, sensitive and strongly correlated both with motor and disability clinical scales. Therefore, this device is suitable as evaluation tool for the upper limb motor performance of patients with sub-acute stroke in clinical practice. TRIAL REGISTRATION: NCT02879279 .

Walking variations in healthy women wearing high-heeled shoes: Shoe size and heel height effects.

BACKGROUND: The use of high heels is widespread in modern society in professional and social contests. Literature showed that wearing high heels can produce injurious effects on several structures from the toes to the pelvis. No studies considered shoe length as an impacting factor on walking with high heels. RESEARCH QUESTION: The aim of this study is to evaluate walking parameters in young healthy women wearing high heels, considering not only the heel height but also the foot/shoe size. METHODS: We evaluate spatio-temporal, kinematic and kinetic data, collected using a 8-camera motion capture system, in a sample of 21 healthy women in three different walking conditions: 1) barefoot, 2) wearing 12 cm high heel shoes independently from shoe size, and 3) wearing shoes with heel height based on shoe size, keeping the ankles' plantar flexion angle constant. The main outcome measures were: spatio-temporal parameters, gait harmony measurement, range of motion, flexion and extension maximal values, power and moment of lower limb joints. RESULTS: Comparing the three walking conditions, the Mixed Anova test, showed significant differences between both high heeled conditions (variable and constant height) and barefoot in spatio-temporal, kinematic and kinetic parameters. SIGNIFICANCE: Regardless of the shoe size, both heeled conditions presented a similar gait pattern and were responsible for negative effects on walking parameters. Considering our results and the relevance of the heel height, further studies are needed to identify a threshold, over which it is possible to observe that wearing high heels could cause harmful effects, independently from the foot/shoe size.

Assessing and treating pain associated with stroke, multiple sclerosis, cerebral palsy, spinal cord injury and spasticity. Evidence and recommendations from the Italian Consensus Conference on Pain in Neurorehabilitation.

Pain is a common and disabling symptom in patients with stroke, multiple sclerosis (MS), cerebral palsy (CP), spinal cord injury (SCI) and other conditions associated with spasticity, but data on its prevalence, and natural history, as well as guidelines on its assessment and treatment in the field of neurorehabilitation, are largely lacking. The Italian Consensus Conference on Pain in Neurorehabilitation (ICCPN) searched and evaluated current evidence on the frequency, evolution, predictors, assessment, and pharmacological and non-pharmacological treatment of pain in patients with stroke, MS, CP, SCI and other conditions associated with spasticity. Patients with stroke, MS, CP, and SCI may suffer from pain related to spasticity, as well as nociceptive and neuropathic pain (NP), whose prevalence, natural history, impact on functional outcome, and predictors are only partially known. Diagnosis and assessment of the different types of pain in these patients is important, because their treatment may differ. Botulinum neurotoxin is the first choice treatment for spasticity, while some antidepressant and antiepileptic drugs may be effective on NP, but pharmacological treatment varies according to the underlying disease. In most cases, a single therapy is not sufficient to treat pain, and a multidisciplinary approach, which include pharmacological and non-pharmacological treatments is needed. Further studies, and in particular randomized controlled trials, are needed on these topics.

Use of a Virtual-Technological Sailing Program to Prepare Children With Disabilities for a Real Sailing Course: Effects on Balance and Quality of Life.

Sailing might produce a positive effect on a patient's general health and become an integrated part of rehabilitation. Our hypothesis was that a specific technological rehabilitation program might be used to prepare a group of disabled subjects for sailing. Seventeen patients (age range: 9-20) with impairments in motor coordination and balance and 15 healthy subjects participated in the study. The study was divided into the virtual-technological sailing phase, theory-practice phase, and sports phase. Proprioceptive platforms were used to evaluate balance, and the Child Health Questionnaire-PF50 was used to evaluate quality of life. Trunk displacement and the center of pressure velocity improved significantly after the virtual-technological sailing program. As regards quality of life, the physical and psychosocial score significantly improved at the end of the program. A technological rehabilitation training improved balance in disabled subjects and may be used to prepare them for a real sailing course. Sailing improves the quality of life of disabled subjects and could be used in the rehabilitation.

Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients.

BACKGROUND: Muscle vibration modifies corticomotor excitability in healthy subjects and reduces muscle tonus in stroke patients. OBJECTIVE: This study examined whether repeated muscle vibration (rMV) applied over the flexor carpi radialis (FCR) and biceps brachii (BB) can induce long-lasting changes, using transcranial magnetic stimulation (TMS), in patients with chronic stroke. METHODS: Thirty hemiparetic patients who offered at least minimal wrist and elbow isometric voluntary contractions were randomly assigned to either an experimental group, which received rMV in addition to physiotherapy (rMV + PT), or a control group that underwent PT alone. The following parameters of the FCR, BB, and extensor digitorum communis (EDC) were measured through TMS before, and 1 hour, 1 week, and 2 weeks after the end of intervention: resting motor threshold (RMT), map area, map volume, short-interval intracortical inhibition (SICI), and intracortical facilitation (ICF). Muscle tonus and motor function were assessed on the same day as TMS. RESULTS: Pre-post analysis revealed a reduction in RMT and an increase in motor map areas occurred in the vibrated muscles only in the rMV + PT group, with an increase in map volumes of all muscles. Moreover, SICI increased in the flexors and decreased in the extensor. These neurophysiological changes lasted for at least 2 weeks after the end of rMV + PT and paralleled the reduction in spasticity and increase in motor function. A significant correlation was found between the degree of spasticity and the amount of intracortical inhibition. CONCLUSION: rMV with PT may be used as a nonpharmacological intervention in the neurorehabilitation of mild to moderate hemiparesis.

In vivo definition of parieto-motor connections involved in planning of grasping movements.

We combined bifocal transcranial magnetic stimulation (TMS) and diffusion tensor imaging (DTI) tractography to investigate in humans the contribution of connections originating from different parietal areas in planning of different reaching to grasp movements. TMS experiments revealed that in the left hemisphere functional connectivity between the primary motor cortex (M1) and a portion of the angular gyrus (AG) close to the caudal intraparietal sulcus was activated during early preparation of reaching and grasping movements only when the movement was made with a whole hand grasp (WHG) towards objects in contralateral space. In contrast, a different pathway, linking M1 with a part of the supramarginal gyrus (SMG) close to the anterior intraparietal sulcus, was sensitive only to the type of grasp required (precision grasping) but not to the position of the object in space. A triple coil experiment revealed that inactivation of the ventral premotor area (PMv) by continuous theta burst stimulation interfered with some of these interactions. Anatomical DTI tractography revealed that AG and SMG are strongly connected with PMv and with M1 by different bundles of the superior longitudinal fasciculus (SLF). These results demonstrate the existence of segregated parieto-premotor-motor pathways crucial for preparation of different grasping actions and indicate that these may process information relevant to both the position of the object and the hand shape required to use it.

TMS activation of interhemispheric pathways between the posterior parietal cortex and the contralateral motor cortex.

Using a twin coil transcranial magnetic stimulation (tc-TMS) approach we have previously demonstrated that facilitation may be detected in the primary motor cortex (M1) following stimulation over the ipsilateral caudal intraparietal sulcus (cIPS). Here we tested the interhemispheric interactions between the IPS and the contralateral motor cortex (M1). We found that conditioning the right cIPS facilitated contralateral M1 when the conditioning stimulus had an intensity of 90% resting motor threshold (RMT) but not at 70% or 110% RMT. Facilitation was maximal when the interstimulus interval (ISI) between cIPS and M1 was 6 or 12 ms. These facilitatory effects were mediated by interactions with specific groups of interneurons in the contralateral M1. In fact, short intracortical inhibition (SICI) was reduced following cIPS stimulation. Moreover, additional comparison of facilitation of responses evoked by anterior-posterior versus posterior-anterior stimulation of M1 suggested that facilitation was more effective on early I1/I2 circuits than on I3 circuits. In contrast to these effects, stimulation of anterior IPS (aIPS) at 90% RMT induced inhibition, instead of facilitation, of contralateral M1 at ISIs of 10-12 ms. Finally, we found similar facilitation between left cIPS and right M1 although the conditioning stimuli had to have a higher intensity compared with stimulation of right cIPS (110% instead of 90% RMT). These findings demonstrate that different subregions of the posterior parietal cortex (PPC) in humans exert both facilitatory and inhibitory effects towards the contralateral primary motor cortex. These corticocortical projections could contribute to a variety of motor tasks such as bilateral manual coordination, movement planning in space and grasping.

Changes in intracortical circuits of the human motor cortex following theta burst stimulation of the lateral cerebellum.

OBJECTIVE: The cerebellum takes part in several motor functions through its influence on the motor cortex (M1). Here, we applied the theta burst stimulation (TBS) protocol, a novel form of repetitive Transcranial Magnetic Stimulation (rTMS) over the lateral cerebellum. The aim of this study was to test whether TBS of the lateral cerebellum could be able to modulate the excitability of the contralateral M1 in healthy subjects. METHODS: Motor-evoked potentials (MEPs) amplitude, short intracortical inhibition (SICI), long intracortical inhibition (LICI) and short intracortical facilitation (SICF) were tested in the M1 before and after cerebellar continuous TBS (cTBS) or intermittent TBS (iTBS). RESULTS: We found that cTBS induced a reduction of SICI and an increase of LICI. On the other hand, cerebellar iTBS reduced LICI. MEPs amplitude also differently vary following cerebellar stimulation with cTBS or iTBS, resulting in a decrease by the former and an increase by the latter. CONCLUSIONS: Although the interpretation of these data remains highly speculative, these findings reveal that the cerebellar cortex undergoes bidirectional plastic changes that modulate different intracortical circuits within the contralateral primary motor cortex. SIGNIFICANCE: Long-lasting modifications of these pathways could be useful to treat various pathological conditions characterized by an altered cortical excitability.

Long-term effects on motor cortical excitability induced by repeated muscle vibration during contraction in healthy subjects.

OBJECTIVE: The effects of a novel repeated muscle vibration intervention (rMV; 100 Hz, 90 min over 3 consecutive days) on corticomotor excitability were studied in healthy subjects. METHODS: rMV was applied over the flexor carpi radialis (FCR) during voluntary contraction (experiment 1), during relaxation and during contraction without vibration (experiment 2). Focal transcranial magnetic stimulation (TMS) was applied before rMV and one hour, and one, two and three weeks after the last muscle vibration intervention. At each of these time points, we assessed the motor map area and volume in the FCR, extensor digitorum communis (EDC) and abductor digiti minimi (ADM). Short-interval intracortical inhibition (SICI) and facilitation (ICF) were tested for the flexor/extensor muscles alone. RESULTS: Following rMV under voluntary contraction, we observed a significant reduction in the FCR map volumes and an enhancement in the EDC. SICI was increased in the FCR and reduced in the EDC. These changes persisted for up to two weeks and occurred at the cortical level in the hemisphere contralateral to the side of the intervention. CONCLUSION: We conclude that rMV, applied during a voluntary contraction, may induce prolonged changes in the excitatory/inhibitory state of the primary motor cortex. These findings may represent an important advance in motor disorder rehabilitation.

Breakdown of inhibitory effects induced by foot motor imagery on hand motor area in lower-limb amputees.

OBJECTIVE: Amputation of a limb induces plastic changes in motor cortex that modify the relationships between the missing limb and the remaining body part representations. We used motor imagery to explore the interactions between a missing lower limb and the hand/forearm cortical representations. METHODS: Eight right leg amputees and nine healthy subjects participated in the study. Focal transcranial magnetic stimulation was used to map out the hand/forearm muscle maps at rest and during imagined ankle dorsiflexion and plantarflexion. RESULTS: In healthy subjects, both motor imagery tasks strongly inhibited the map volume and contracted the map area of the hand muscles. By contrast, in amputees, imagined dorsiflexion and plantarflexion enhanced the map area and volume of the hand muscles. In the forearm muscle maps, both groups displayed a similar pattern of isodirectional coupling during both motor imagery tasks. Imagined dorsiflexion facilitated MEP amplitudes of the extensor and inhibited the flexor muscles of the upper limb. This pattern was reversed during imagined plantarflexion. CONCLUSIONS: We argue that there exists an inhibitory relationship between the foot and hand motor cortices that ceases to exist after leg amputation. SIGNIFICANCE: The understanding of these functional mechanisms may shed light on the motor network underlying interlimb coordination.

Functional overlap between hand and forearm motor cortical representations during motor cognitive tasks.

OBJECTIVE: The aim of this study was to verify whether motor imagery (MI) and observation of a movement (MO) enhanced cortical representations of the hand/forearm muscles not primarily involved in the task. We also explored the existence of functional overlaps in the upper-limb cortical representations during the aforementioned tasks. METHODS: Focal transcranial magnetic stimulation (TMS) was used to map out the cortical representation of the opponens pollicis (OP, target muscle) and other hand and forearm muscles at rest and during MI and MO. RESULTS: The MI and MO tasks induced similar changes in the area and volume of both the OP and synergic muscles. No significant changes were observed in the cortical excitability of the remaining muscles. The superimposition of different muscle maps revealed extensive functional overlaps in the hand/forearm cortical territories. CONCLUSIONS: This study demonstrates that neither the MI nor MO changes single muscle motor responses and that the hand/forearm muscle maps extensively overlap during motor cognitive tasks. SIGNIFICANCE: The data reported in this study support the notion that the basic unit of cortical output is not the mere activation of a given muscle. This flexible organization may have important implications in motor learning and plasticity.