Anatomical landmarks for ultrasound-guided rectus femoris diagnostic nerve block in post-stroke spasticity.

Introduction/Purpose: To determine the location of the rectus femoris (RF) motor branch nerve, as well as its coordinates with reference to anatomical and ultrasound landmarks. Methods: Thirty chronic stroke patients with stiff knee gait (SKG) and RF hyperactivity were included. The motor nerve branch to the RF muscle was identified medially to the vertical line from anterior superior iliac spine and the midpoint of the superior margin of the patella (line AP) and vertically to the horizontal line from the femoral pulse and its intersection point with the line AP (line F). The point of the motor branch (M) was located with ultrasound, and nerve depth and subcutaneous tissue thickness (ST) were calculated. Results: The coordinates of the motor branch to the RF were 2.82 (0.47) cm medially to the line AP and 4.61 (0.83) cm vertically to the line F. Nerve depth and subcutaneous tissue thickness were 2.71 (0.62) cm and 1.12 (0.75) cm, respectively. Conclusion: The use of specific coordinates may increase clinicians' confidence when performing RF motor nerve block. This could lead to better decision-making when assessing SKG in chronic stroke patients.

A Narrative Review on Multi-Domain Instrumental Approaches to Evaluate Neuromotor Function in Rehabilitation.

In clinical scenarios, the use of biomedical sensors, devices and multi-parameter assessments is fundamental to provide a comprehensive portrait of patients' state, in order to adapt and personalize rehabilitation interventions and support clinical decision-making. However, there is a huge gap between the potential of the multidomain techniques available and the limited practical use that is made in the clinical scenario. This paper reviews the current state-of-the-art and provides insights into future directions of multi-domain instrumental approaches in the clinical assessment of patients involved in neuromotor rehabilitation. We also summarize the main achievements and challenges of using multi-domain approaches in the assessment of rehabilitation for various neurological disorders affecting motor functions. Our results showed that multi-domain approaches combine information and measurements from different tools and biological signals, such as kinematics, electromyography (EMG), electroencephalography (EEG), near-infrared spectroscopy (NIRS), and clinical scales, to provide a comprehensive and objective evaluation of patients' state and recovery. This multi-domain approach permits the progress of research in clinical and rehabilitative practice and the understanding of the pathophysiological changes occurring during and after rehabilitation. We discuss the potential benefits and limitations of multi-domain approaches for clinical decision-making, personalized therapy, and prognosis. We conclude by highlighting the need for more standardized methods, validation studies, and the integration of multi-domain approaches in clinical practice and research.

Increasing the Passive Range of Joint Motion in Stroke Patients Using Botulinum Toxin: The Role of Pain Relief.

By blocking the release of neurotransmitters, botulinum toxin A (BoNT-A) is an effective treatment for muscle over-activity and pain in stroke patients. BoNT-A has also been reported to increase passive range of motion (p-ROM), the decrease of which is mainly due to muscle shortening (i.e., muscle contracture). Although the mechanism of action of BoNT-A on p-ROM is far from understood, pain relief may be hypothesized to play a role. To test this hypothesis, a retrospective investigation of p-ROM and pain was conducted in post-stroke patients treated with BoNT-A for upper limb hypertonia. Among 70 stroke patients enrolled in the study, muscle tone (Modified Ashworth Scale), pathological postures, p-ROM, and pain during p-ROM assessment (Numeric Rating Scale, NRS) were investigated in elbow flexors (48 patients) and in finger flexors (64 patients), just before and 3-6 weeks after BoNT-A treatment. Before BoNT-A treatment, pathological postures of elbow flexion were found in all patients but one. A decreased elbow p-ROM was found in 18 patients (38%). Patients with decreased p-ROM had higher pain-NRS scores (5.08 ± 1.96, with a pain score ≥8 in 11% of cases) than patients with normal p-ROM (0.57 ± 1.36) (p < 0.001). Similarly, pathological postures of finger flexion were found in all patients but two. A decreased finger p-ROM was found in 14 patients (22%). Pain was more intense in the 14 patients with decreased p-ROM (8.43 ± 1.74, with a pain score ≥ 8 in 86% of cases) than in the 50 patients with normal p-ROM (0.98 ± 1.89) (p < 0.001). After BoNT-A treatment, muscle tone, pathological postures, and pain decreased in both elbow and finger flexors. In contrast, p-ROM increased only in finger flexors. The study discusses that pain plays a pivotal role in the increase in p-ROM observed after BoNT-A treatment.

Development and Rasch Validation of an Observational Assessment Tool of Upper Limb Functional Impairment in Stroke Survivors: Functional Assessment Test for Upper Limb.

OBJECTIVE: To develop and validate a quick observational clinical tool, the Functional ASsessment Test for Upper Limb (FAST-UL), for the evaluation of upper limb impairment in goal-directed functional-oriented motor tasks after stroke. DESIGN: Observational, cross-sectional, psychometric study. SETTING: Inpatient and outpatient rehabilitation clinic. PARTICIPANTS: A total of 188 post-stroke survivors (mean age 65.2±17.7 years, 61% men, 48% with ischemic stroke and 66% in the sub-acute phase; N=188). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Principal component analysis and Rasch analysis through a Partial Credit Model were used to assess the structure and psychometric properties of the 5 items of the FAST-UL (Hand to Mouth [HtM], Reach to Target, Prono-Supination, Grasp and Release, and Pinch and Release [PaR]). RESULTS: The Cronbach's α equal to 0.96 was indicative of an acceptable internal consistency; the reliability, as measured through the Person Separation Reliability equal to 0.87, was good. The FAST-UL tool was unidimensional. All the FAST-UL items were found to fit well the Rasch measurement model. The easiest to perform FAST-UL item was the HtM movement while the most difficult was the PaR movement. CONCLUSIONS: The FAST-UL is a quick, easy-to-administer observational assessment tool of upper limb motor impairment in post-stroke survivors with good item-level psychometric properties.

Reactive Exercises with Interactive Objects: Interim Analysis of a Randomized Trial on Task-Driven NMES Grasp Rehabilitation for Subacute and Early Chronic Stroke Patients.

Enriched environments and tools are believed to promote grasp rehabilitation after stroke. We designed S2, an interactive grasp rehabilitation system consisting of smart objects, custom orthoses for selective grasp constraining, and an electrode array system for forearm NMES. Motor improvements and perceived usability of a new enriched upper limb training system for sub-acute stroke patients was assessed in this interim analysis. INCLUSION CRITERIA: sub-acute stroke patients with MMSE>20, ipsilesional MI>80%, and contralesional MI<80%. Effects of 30-min therapy supplements, conventional vs. S2 prototype, are compared through a parallel two-arms dose-matched open-label trial, lasting 27 sessions. Clinical centres: Asklepios Neurologische Klinik Falkenstein, Königstein im Taunus, Germany, and Clinica Villa Beretta, Costa Masnaga, Italy. Assessment scales: ARAT, System Usability, and Technology Acceptance. METHODOLOGY: 26 participants were block randomized, allocated to the study (control N=12, experimental N=14) and underwent the training protocol. Among them, 11 participants with ARAT score at inclusion below 35, n = 6 in the experimental group, and n = 5 in the control group were analysed. RESULTS: participants in the enriched treatment group displayed a larger improvement in the ARAT scale (+14.9 pts, pval=0.0494). Perceived usability differed between clinics. No adverse effect was observed in relation to the treatments. Trial status: closed. CONCLUSIONS: The S2 system, developed according to shared clinical directives, was tested in a clinical proof of concept. Variations of ARAT scores confirm the feasibility of clinical investigation for hand rehabilitation after stroke.

A Robotic System with EMG-Triggered Functional Eletrical Stimulation for Restoring Arm Functions in Stroke Survivors.

BACKGROUND: Robotic systems combined with Functional Electrical Stimulation (FES) showed promising results on upper-limb motor recovery after stroke, but adequately-sized randomized controlled trials (RCTs) are still missing. OBJECTIVE: To evaluate whether arm training supported by RETRAINER, a passive exoskeleton integrated with electromyograph-triggered functional electrical stimulation, is superior to advanced conventional therapy (ACT) of equal intensity in the recovery of arm functions, dexterity, strength, activities of daily living, and quality of life after stroke. METHODS: A single-blind RCT recruiting 72 patients was conducted. Patients, randomly allocated to 2 groups, were trained for 9 weeks, 3 times per week: the experimental group performed task-oriented exercises assisted by RETRAINER for 30 minutes plus ACT (60 minutes), whereas the control group performed only ACT (90 minutes). Patients were assessed before, soon after, and 1 month after the end of the intervention. Outcome measures were as follows: Action Research Arm Test (ARAT), Motricity Index, Motor Activity Log, Box and Blocks Test (BBT), Stroke Specific Quality of Life Scale (SSQoL), and Muscle Research Council. RESULTS: All outcomes but SSQoL significantly improved over time in both groups (P < .001); a significant interaction effect in favor of the experimental group was found for ARAT and BBT. ARAT showed a between-group change of 11.5 points (P = .010) at the end of the intervention, which increased to 13.6 points 1 month after. Patients considered RETRAINER moderately usable (System Usability Score of 61.5 ± 22.8). CONCLUSIONS: Hybrid robotic systems, allowing to perform personalized, intensive, and task-oriented training, with an enriched sensory feedback, was superior to ACT in improving arm functions and dexterity after stroke.

Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects.

BACKGROUND: Overground Robot-Assisted Gait Training (o-RAGT) provides intensive gait rehabilitation. This study investigated the efficacy of o-RAGT in subacute stroke subjects, compared to conventional gait training. METHODS: A multicenter randomized controlled trial was conducted on 75 subacute stroke subjects (38 in the Experimental Group (EG) and 37 in the Control Group (CG)). Both groups received 15 sessions of gait training (5 sessions/week for 60 min) and daily conventional rehabilitation. The subjects were assessed at the beginning (T1) and end (T2) of the training period with the primary outcome of a 6 Minutes Walking Test (6MWT), the Modified Ashworth Scale of the Affected lower Limb (MAS-AL), the Motricity Index of the Affected lower Limb (MI-AL), the Trunk Control Test (TCT), Functional Ambulation Classification (FAC), a 10 Meters Walking Test (10MWT), the modified Barthel Index (mBI), and the Walking Handicap Scale (WHS). RESULTS: The 6MWT increased in both groups, which was confirmed by both frequentist and Bayesian analyses. Similar outcomes were registered in the MI-AL, 10MWT, mBI, and MAS-AL. The FAC and WHS showed a significant number of subjects improving in functional and community ambulation in both groups at T2. CONCLUSIONS: The clinical effects of o-RAGT were similar to conventional gait training in subacute stroke subjects. The results obtained in this study are encouraging and suggest future clinical trials on the topic.

Robot Fully Assisted Upper-Limb Functional Movements Against Gravity to Drive Recovery in Chronic Stroke: A Pilot Study.

Background: Stroke is becoming more and more a disease of chronically disabled patients, and new approaches are needed for better outcomes. An intervention based on robot fully assisted upper-limb functional movements is presented. Objectives: To test the immediate and sustained effects of the intervention in reducing impairment in chronic stroke and to preliminarily verify the effects on activity. Methodology: Nineteen patients with mild-to-severe impairment underwent 12 40-min rehabilitation sessions, 3 per week, of robot-assisted reaching and hand-to-mouth movements. The primary outcome measure was the Fugl-Meyer Assessment (FMA) at T1, immediately after treatment (n = 19), and at T2, at a 6-month follow-up (n = 10). A subgroup of 11 patients was also administered the Wolf Motor Function Test Time (WMFT TIME) and Functional Ability Scale (WMFT FAS) and Motor Activity Log (MAL) Amount Of Use (AOU), and Quality Of Movement (QOM). Results: All patients were compliant with the treatment. There was improvement on the FMA with a mean difference with respect to the baseline of 6.2 points at T1, after intervention (n = 19, 95% CI = 4.6-7.8, p < 0.0002), and 5.9 points at T2 (n = 10, 95% CI = 3.6-8.2, p < 0.005). Significant improvements were found at T1 on the WMFT FAS (n = 11, +0.3/5 points, 95% CI = 0.2-0.4, p < 0.004), on the MAL AOU (n = 11, +0.18/5, 95% CI = 0.07-0.29, p < 0.02), and the MAL QOM (n = 11, +0.14/5, 95% CI = 0.08-0.20, p < 0.02). Conclusions: Motor benefits were observed immediately after intervention and at a 6-month follow-up. Reduced impairment would appear to translate to increased activity. Although preliminary, the results are encouraging and lay the foundation for future studies to confirm the findings and define the optimal dose-response curve. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03208634.

Application of upper-limb dynamic pseudoelastic splinting in the treatment of stroke chronic patient: a pilot assessment.

PURPOSE: The chronic sequelae of stroke are often a strong limitation to patient's quality of life. New non-invasive elective treatments are required to support postural and functional improvements long after the primary insult. This study is an uncontrolled pilot evaluation of pseudoelastic orthotics for post-stroke upper-limb rehabilitation. MATERIALS AND METHODS: Six chronic hemiplegic patients (3.8 ± 1.7 years since stroke) were evaluated with clinical scales, covering the ICF domains of body functions and structures (Modified Ashworth Score [MAS], Medical Research Council Scale for Muscle Strength, Fugl-Meyer [FM], Motricity Index [MI]), activities (Wolf Motor Function Test [WMF], Motor Activity Log [MAL]) and participation (quality of life questionnaires); sensors applied to the orthosis were used to assess changes in the articular and functional domains over a month's treatment. RESULTS: Significant gains were achieved in elbow spasticity (MAS, p = .020), upper-limb motor function (FM, p = .005), reaching task (p = .035), and gait (p = .00046) speed. Most patients improved in functional tasks (WMF), but this did not reflect in daily-life activities as measured with MAL. Some patients reported an improved quality of life, especially the quality of sleep. CONCLUSIONS: Pseudoelastic orthoses could be a comfortable and useful adjunct in the long-term management of stroke. Broader trials will have to confirm these preliminary observations.Implications for rehabilitationUse of new materials in neuromuscular rehabilitation.Customised and adjustable therapeutic action obtained with dynamic personalised orthoses.Non-invasive interventions could be of help for patients with chronic disability.

Discontinuation of botulinum neurotoxin type-A treatment during COVID-19 pandemic: an Italian survey in post stroke and traumatic brain injury patients living with spasticity.

BACKGROUND: The COVID-19 pandemic has affected health-care systems worldwide, including the outpatient spasticity care with botulinum neurotoxin toxin type A (BoNT-A). AIM: The aim of this study was to investigate the impact of discontinuation of BoNT-A treatment on patients living with spasticity during the COVID-19 quarantine. DESIGN: A multicentric cross-sectional study. SETTING: Outpatients setting. POPULATION: Patients with spasticity after stroke and traumatic brain injury treated with BoNT-A. METHODS: A phone-based survey was conducted from March to May, 2020. Based on the International Classification of Functioning, Disability and Health (ICF), an ad hoc questionnaire CORTOX (CORonavirus TOXin survey) was developed to investigate patients' experiences following the discontinuation of their usual treatment for spasticity due to the lockdown and its implication on their health perception. It assessed patients' condition and explored different ICF domains related to spasticity: unpleasant sensations, mobility, self-care, facilitators and psychosocial factors. The sum of those represented the CORTOX score (Max 142). The questionnaire also collected data about the impact of COVID-19 on patients' wellbeing (mood, sleep, relationships, community life, motivation). RESULTS: A total of 151 participants completed the survey. Most participants (72.2%) experienced a worsening in perceived spasticity, 53% got worse in independence and 70.9% had a negative impact on quality of life. The mean CORTOX score was 52.85±27.25, reflecting a perceived worsening in all ICF domains investigated. Moderate to strong correlations were found between different sub-scores of the questionnaire and severity of spasticity (P<0.001). COVID-19 psychosocial related factors were associated with loss of independence (P<0.05) but only mood was associated with worsening of spasticity (P<0.001). The lack of rehabilitation therapy was significantly associated with the worsening of independence but not with the worsening of spasticity. Finally, respondents reported that BoNT-A was useful to their condition and should not be discontinued. CONCLUSIONS: The discontinuation of BoNT-A treatment was associated with worsening of activities and participation and perceived spasticity. COVID-19 related problems and rehabilitation showed an association with loss of independence. CLINICAL REHABILITATION IMPACT: This study will provide useful information in the field of spasticity management using a patient's centred approach, with consistent quantitative and qualitative information.

Using an Accelerometer-Based Step Counter in Post-Stroke Patients: Validation of a Low-Cost Tool.

Monitoring the real-life mobility of stroke patients could be extremely useful for clinicians. Step counters are a widely accessible, portable, and cheap technology that can be used to monitor patients in different environments. The aim of this study was to validate a low-cost commercial tri-axial accelerometer-based step counter for stroke patients and to determine the best positioning of the step counter (wrists, ankles, and waist). Ten healthy subjects and 43 post-stroke patients were enrolled and performed four validated clinical tests (10 m, 50 m, and 6 min walking tests and timed up and go tests) while wearing five step counters in different positions while a trained operator counted the number of steps executed in each test manually. Data from step counters and those collected manually were compared using the intraclass coefficient correlation and mean average percentage error. The Bland-Altman plot was also used to describe agreement between the two quantitative measurements (step counter vs. manual counting). During walking tests in healthy subjects, the best reliability was found for lower limbs and waist placement (intraclass coefficient correlations (ICCs) from 0.46 to 0.99), and weak reliability was observed for upper limb placement in every test (ICCs from 0.06 to 0.38). On the contrary, in post-stroke patients, moderate reliability was found only for the lower limbs in the 6 min walking test (healthy ankle ICC: 0.69; pathological ankle ICC: 0.70). Furthermore, the Bland-Altman plot highlighted large average discrepancies between methods for the pathological group. However, while the step counter was not able to reliably determine steps for slow patients, when applied to the healthy ankle of patients who walked faster than 0.8 m/s, it counted steps with excellent precision, similar to that seen in the healthy subjects (ICCs from 0.36 to 0.99). These findings show that a low-cost accelerometer-based step counter could be useful for measuring mobility in select high-performance patients and could be used in clinical and real-world settings.

A Hybrid Robotic System for Arm Training of Stroke Survivors: Concept and First Evaluation.

OBJECTIVE: To develop and evaluate a hybrid robotic system for arm recovery after stroke, combining ElectroMyoGraphic (EMG)-triggered functional electrical stimulation (FES) with a passive exoskeleton for upper limb suspension. METHODS: The system was used in a structured exercise program resembling activities of daily life. Exercises execution was continuously controlled using angle sensor data and radio-frequency identification technology. The training program consisted of 27 sessions lasting 30 min each. Seven post-acute stroke patients were recruited from two clinical sites. The efficacy of the system was evaluated in terms of action research arm test, motricity index, motor activity log, and box & blocks tests. Furthermore, kinematics-based and EMG-based outcome measures were derived directly from data collected during training sessions. RESULTS: All patients showed an improvement of motor functions at the end of the training program. After training, the exercises were in most cases executed faster, smoother, and with an increased range of motion. Subjects were able to trigger FES, but in some cases, they did not maintain the voluntary effort during task execution. All subjects but one considered the system usable. CONCLUSION: The preliminary results showed that the system can be used in a clinical environment with positive effects on arm functional recovery. However, only the final results of the currently ongoing clinical trial will unveil the system's full potential. SIGNIFICANCE: The presented hybrid robotic system is highly customizable, allows to monitor the daily performance, requires low supervision of the therapist, and might have the potential to enhance arm recovery after stroke.

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments.

BACKGROUND: Wearable powered exoskeletons provide intensive overground gait training with patient's active participation: these features promote a successful active motor relearning of ambulation in stroke survivors. AIM: The aim of this study was to investigate the feasibility and the clinical effects of an overground exoskeleton-assisted gait training (OEAGT) in subacute stroke patients. DESIGN: Prospective, pilot pre-post, open label, non-randomized experimental study. SETTING: Four Italian neurological rehabilitation centers. POPULATION: Forty-eight subacute stroke patients were enrolled. Two patients dropped out because of medical problems. Data analysis was conducted on 46 subjects (56.84±14.29 years; 27 male; 29 ischemic; 24 left hemiparesis). METHODS: Patients underwent 15±2 sessions (60 min/session, 3-5 times/week) of OEAGT. Clinical and gait assessments were performed at the beginning (T1) and at the end (T2) of the training period: modified Barthel Index (BI), modified Ashworth Scale at Hip (MAS-H), Knee (MAS-K), and Ankle (MAS-A) level, Motricity Index (MI), Trunk Control Test (TCT), Functional Ambulation Classification (FAC), Walking Handicap Scale (WHS), 10-Meter Walking Test (10MWT), 6-Minute Walking Test (6mWT), Timed Up-and-Go test (TUG). The Technology Acceptance Model (TAM) questionnaire evaluated the acceptance of OEAGT by patients. Data stratification was performed using the time post the acute event and the onset of rehabilitation treatment, and the MI at T1. Wilcoxon's test (P<0.05) was used. RESULTS: All clinical scales significantly improved at T2; no statistically significant changes were reported for MAS-H, MAS-K, MAS-A. The 69.57% patients were able to walk at T1; 17.39% were not able to walk at T1 but regained ambulation at T2; and 13.04% were not able to walk at either T1 or T2. The ambulant patients showed a statistical improvement in speed measured during the 10MWT and in the distance covered over a time of 6 minutes (6mWT). The results from the TAM questionnaire showed that all subjects perceived the OEAGT positively. The data stratification analysis suggests that the OEAGT does not have any restriction of use. CONCLUSIONS: The OEAGT improved the clinical and gait outcomes in subacute patients. Randomized studies on larger samples are needed to confirm these data and to assess the efficacy of OEAGT. CLINICAL REHABILITATION IMPACT: Introduce innovative rehabilitation strategies based on customized OEAGT.

Exoskeleton and End-Effector Robots for Upper and Lower Limbs Rehabilitation: Narrative Review.

Recovery of upper and lower limbs function is essential to reach independence in daily activities in patients with upper motor neuron syndrome (UMNS). Rehabilitation can provide a guide for motor recovery influencing the neurobiology of neuronal plasticity providing controlled, repetitive, and variable patterns. Increasing therapy dosage, intensity, number of repetition, execution of task-oriented exercises, and combining top-down and bottom-up approaches can promote plasticity and functional recovery. Robotic exoskeletons for upper and lower limbs, based on the principle of motor learning, have been introduced in neurorehabilitation. In this narrative review, we provide an overview of literature published on exoskeleton devices for upper and lower limb rehabilitation in patients with UMNS; we summarized the available current research evidence and outlined the new challenges that neurorehabilitation and bioengineering will have to face in the upcoming years. Robotic treatment should be considered a rehabilitation tool useful to generate a more complex, controlled multisensory stimulation of the patient and useful to modify the plasticity of neural connections through the experience of movement. Efficacy and efficiency of robotic treatment should be defined starting from intensity, complexity, and specificity of the robotic exercise, that are related to human-robot interaction in terms of motion, emotion, motivation, meaning of the task, feedback from the exoskeleton, and fine motion assistance. Duration of a single session, global period of the treatment, and the timing for beginning of robotic treatment are still open questions. There is the need to evaluate and individualize the treatment according to patient's characteristics. Robotic devices for upper and lower limbs open a window to define therapeutic modalities as possible beneficial drug, able to boost biological, neurobiological, and epigenetic changes in central nervous system. We need to implement large and innovative research programs to answer these issues in the near future.

Management of intrathecal baclofen therapy for severe acquired brain injury: consensus and recommendations for good clinical practice.

Although widespread in the treatment of generalised spasticity due to severe acquired brain injury, clinical use of intrathecal baclofen administered through an implanted catheter is not yet supported by full scientific evidence. The aim of the study is to provide recommendations for good clinical practice regarding intrathecal baclofen therapy. We used a modified RAND Delphi method to develop consensus-based medical guidelines, involving clinicians who use intrathecal baclofen therapy throughout Italy. The clinicians were asked 38 questions grouped in six areas (patient selection, contraindications for implant, tests prior to implant, method of implant and management of therapy, efficacy evaluation and goal setting, and management of complications). To establish consensus, 75% agreement was required in answers to every question. Consensus was reached on the second round of the Delphi process on 27/38 questions (71%), specifically those regarding identification of objectives, efficacy evaluation, and method of implant and management of therapy, whereas management of complications and contraindications for implant remained critical areas. Despite the limits of our method, a set of recommendations was drawn up for clinical practice in this sector. The study also revealed residual critical areas and indicated future lines of research necessary to reach evidence-based consensus.

Wearable robotic exoskeleton for overground gait training in sub-acute and chronic hemiparetic stroke patients: preliminary results.

BACKGROUND: Recovery of therapeutic or functional ambulatory capacity in post-stroke patients is a primary goal of rehabilitation. Wearable powered exoskeletons allow patients with gait dysfunctions to perform over-ground gait training, even immediately after the acute event. AIM: To investigate the feasibility and the clinical effects of an over-ground walking training with a wearable powered exoskeleton in sub-acute and chronic stroke patients. DESIGN: Prospective, pilot pre-post, open label, non-randomized experimental study. SETTING: A single neurological rehabilitation center for inpatients and outpatients. POPULATION: Twenty-three post-stroke patients were enrolled: 12 sub-acute (mean age: 43.8±13.3 years, 5 male and 7 female, 7 right hemiparesis and 5 left hemiparesis) and 11 chronic (mean age: 55.5±15.9 years, 7 male and 4 female, 4 right hemiparesis and 7 left hemiparesis) patients. METHODS: Patients underwent 12 sessions (60 min/session, 3 times/week) of walking rehabilitation training using Ekso™, a wearable bionic suit that enables individuals with lower extremity disabilities and minimal forearm strength to stand up, sit down and walk over a flat hard surface with a full weight-bearing reciprocal gait. Clinical evaluations were performed at the beginning of the training period (t0), after 6 sessions (t1) and after 12 sessions (t2) and were based on the Ashworth scale, Motricity Index, Trunk Control Test, Functional Ambulation Scale, 10-Meter Walking Test, 6-Minute Walking Test, and Walking Handicap Scale. Wilcoxon's test (P<0.05) was used to detect significant changes. RESULTS: Statistically significant improvements were observed at the three assessment periods for both groups in Motricity Index, Functional Ambulation Scale, 10-meter walking test, and 6-minute walking test. Sub-acute patients achieved statistically significant improvement in Trunk Control Test and Walking Handicap Scale at t0-t2. Sub-acute and chronic patient did not achieve significant improvement in Ashworth scale at t0-t2. CONCLUSIONS: Twelve sessions of over-ground gait training using a powered wearable robotic exoskeleton improved ambulatory functions in sub-acute and chronic post-stroke patients. Large, randomized multicenter studies are needed to confirm these preliminary data. CLINICAL REHABILITATION IMPACT: To plan a completely new individual tailored robotic rehabilitation strategy after stroke, including task-oriented over-ground gait training.

Using robot fully assisted functional movements in upper-limb rehabilitation of chronic stroke patients: preliminary results.

BACKGROUND: Robotic rehabilitation is promising to promote function in stroke patients. The assist as needed training paradigm has shown to stimulate neuroplasticity but often cannot be used because stroke patients are too impaired to actively control the robot against gravity. AIM: To verify whether a rehabilitation intervention based on robot fully assisted reaching against gravity (RCH) and hand-to-mouth (HTM) can promote upper-limb function in chronic stroke. DESIGN: Cohort study. SETTING: Chronic stroke outpatients referring to the robotic rehabilitation lab of a rehabilitation centre. POPULATION: Ten chronic stroke patients with mild to moderate upper-limb hemiparesis. METHODS: Patients underwent 12 sessions (3 per week) of robotic treatment using an end-effector robot Every session consisted of 20 minutes each of RCH and HtM; movements were fully assisted, but patients were asked to try to actively participate. The Fugl-Meyer Assessment (FMA) was the primary outcome measure; Medical Research Council and Modified Ashworth Scale were the secondary outcome measures. RESULTS: All patients, but one, show functional improvements (FMA section A-D, mean increment 7.2±3.9 points, P<0.008). CONCLUSIONS: This preliminary study shows that a robotic intervention based on functional movements, fully assisted, can be effective in promoting function in chronic stroke patients. These results are promising considering the short time of the intervention (1 month) and the time from the stroke event, which was large (27±20 months). A larger study, comprehensive of objective instrumental measures, is necessary to confirm the results. CLINICAL REHABILITATION IMPACT: This intervention could be extended even to subacute stroke and other neurological disorders.

Systematic review of outcome measures of walking training using electromechanical and robotic devices in patients with stroke.

OBJECTIVE: The aim of this systematic review was to identify appropriate selection criteria of clinical scales for future trials, starting from those most commonly reported in the literature, according to their psychometric properties and International Classification of Functioning, Disability and Health (ICF) domains. DATA SOURCES: A computerized literature research of articles was conducted in MEDLINE, EMBASE, CINALH, PubMed, PsychINFO and Scopus databases. STUDY SELECTION: Clinical trials evaluating the effects of electromechanical and robot-assisted gait training trials in stroke survivors. DATA EXTRACTION: Fifteen independent authors performed an extensive literature review. DATA SYNTHESIS: A total of 45 scales was identified from 27 studies involving 966 subjects. The most commonly used outcome measures were: Functional Ambulation Category (18 studies), 10-Meter Walking Test (13 studies), Motricity Index (12 studies), 6-Minute Walking Test (11 studies), Rivermead Mobility Index (8 studies) and Berg Balance Scale (8 studies). According to the ICF domains 1 outcome measure was categorized into Body Function and Structure, 5 into Activity and none into Participation. CONCLUSION: The most commonly used scales evaluated the basic components of walking. Future studies should also include instrumental evaluation. Criteria for scale selection should be based on the ICF framework, psychometric properties and patient characteristics.

Paroxysmal episodic hypothalamic instability with hypothermia after traumatic brain injury.

This case report describes a patient in vegetative state after severe traumatic brain injury (TBI) with hypothalamic damage and clinical manifestations of autonomic dysfunction. He also presented late onset paroxysmal hypothermia associated with mild bradycardia and hypotension. Hypothermia due to traumatic lesions of the hypothalamus is an uncommon clinical problem and few cases have been reported; no cases could be found in the literature which evidenced periodic hypothermia associated with clinical features of autonomic dysfunction after TBI. In the article, the main causes and the primary pathophysiology of hypothermia after TBI are discussed. The manifestations in this patient have been interpreted as possible consequences of autonomic dysfunction and considered atypical and rare clinical expression of acute post-traumatic hypothalamic instability.