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).

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.

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 .

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.

Technological rehabilitation versus conventional rehabilitation following hip replacement: A prospective controlled study.

BACKGROUND: Among new technological rehabilitation systems, there are proprioceptive platforms. These could be useful to improve static and dynamic balance. OBJECTIVE: To evaluate technological proprioceptive rehabilitation compared to conventional rehabilitation in patients after total hip arthroplasty (THA). METHODS: Sixty-four patients after THA were divided in two groups: a conventional group (CG) and a technological group (TG) treated with proprioceptive platforms. Before (T0) and after 20 sessions (T1), we recorded static and dynamic balance. Clinical and disability scales (Modified Harris Hip Score, Barthel Index, Deambulation Index), pain scales (ID-PAIN, DN4, VAS) and QoL scale (SF-36) were administered to patients during T0 and T1. Mann-Whitney U test was used for stabilometric and dynamic assessments to detect differences between groups of patients and healthy subjects. The Wilcoxon signed-rank test was used for the within-group analysis and the ANCOVA test for the analysis between groups of patients. RESULTS: All scales improved significantly in both groups after treatment (p< 0.05). Static balance improved in both groups, but there were greater improvements in the TG than in the CG. All dynamic balance indexes showed significant improvements only in the TG after treatment. CONCLUSIONS: Both treatments improved the clinical, disability, pain, and QoL scales, as well as static balance, but only proprioceptive technological rehabilitation improved dynamic balance. Rehabilitation through proprioceptive platforms can indeed improve static and dynamic balance, which are both crucial for the patient's safety and autonomy.

The reaching movement in breast cancer survivors: Attention to the principles of rehabilitation.

INTRODUCTION: Breast-cancer is leading cause of morbidity and mortality in women. The prognosis and survival rate of women with breast-cancer have significantly improved worldwide; more attention needs to be paid to rehabilitative interventions after surgery. This paper describes use of reaching movement to assess upper limb motorcontrol and functional ability after breast-cancer surgery (BC). MATERIAL AND METHODS: We conducted a cross-sectional observational study consisting of biomechanical evaluation of upper limb limitations in women BC, versus a controlgroup (CG). Thirty breast-cancer survivors and thirty healthy women participated in this study. Both groups were subjected to clinical evaluation of the shoulder joint ROM on the operated side, as an assessment of the muscular-strength of the shoulder with the MRC-scale. The Functional-Assessment was evaluated by the DASH and Constant-Murley-Score. The EORTC QLQ-C30 and VAS were used to measure the quality of life assessment and pain respectively. A Biomechanical evaluation was performed, using Reaching-Task and Surface-EMG. RESULTS: Normal Jerk for BC was higher than CG. Target approaching velocity and movement duration BC was lower than CG. Synergy Anterior Deltoid/Triceps Brachii muscles in CG was higher than BC.

Mobility Disorders in Stroke, Parkinson Disease, and Multiple Sclerosis: A Multicenter Cross-Sectional Study.

OBJECTIVE: The aims of the study were to compare mobility in multiple sclerosis, Parkinson disease, and stroke, and to quantify the relationship between mobility and participation restrictions. DESIGN: This is a multicenter cross-sectional study. Included were compliant subjects with Parkinson disease, multiple sclerosis, and stroke seen for rehabilitation, with no comorbidities interfering with mobility. Functional scales were applied to each subject to investigate gait speed (10-meter walking test), balance while maintaining body position (Berg Balance Scale), dynamic balance and mobility (Timed Up and Go and Dynamic Gait Index), and participation (Community Integration Questionnaire). RESULTS: Two hundred ninety-nine patients (111 multiple sclerosis, 94 Parkinson disease, and 94 stroke) were enrolled. Stroke had the slowest gait speed (mean gait speed = 0.9 m/sec) compared with Parkinson disease (1.1 m/sec), and multiple sclerosis (1.2 m/sec) (P < 0.001). Multiple sclerosis was more limited than Parkinson disease and stroke in dynamic balance both in the Timed Up and Go Test (multiple sclerosis = 16.7 secs, Parkinson disease = 11.4 secs, stroke = 14.0 secs; P < 0.001) and Dynamic Gait Index (multiple sclerosis = 11.6 points, Parkinson disease = 12.9 points, stroke = 13.6 points; P = 0.03); ability to maintain balance and body position (Berg Balance Scale) was more affected in stroke and Parkinson disease than multiple sclerosis (multiple sclerosis = 42.6 points, Parkinson disease = 39.4 points, stroke = 39.7 points; P = 0.03). Balance disorders were associated with participation restrictions but not gait speed. CONCLUSIONS: Neurological conditions have differing impacts on gait and balance, leading to different levels of participation restriction.

Educational and Exercise Intervention to Prevent Falls and Improve Participation in Subjects With Neurological Conditions: The NEUROFALL Randomized Controlled Trial.

Background: Falls, mobility impairments and lack of social support lead to participation restrictions in people with neurological conditions. The aim of this multicenter, single blinded randomized controlled trial was to test whether an educational program focusing on fall prevention and safe mobility reduces falls and increases social participation among people with neurological conditions. Methods: Ninety people with Stroke (n = 25), multiple sclerosis (n = 33) and Parkinson disease (n = 32), median age 63 (31-89), were randomized. A permuted block algorithm stratified by field center was used to allocate participants to an education group (EG, n = 42) consisting of an educational program focused on fall prevention and tailored balance exercises and a control group (CG, n = 48) receiving usual treatments. After baseline assessment, each participants was followed for 6 months with telephone contacts by blinded interviewers. Being fallers (>1 fall) and time to become a faller were used as primary outcomes. Community Integration Questionnaire (CIQ) and Instrumental Activities of Daily Living (IADL) scales assessed treatment effects on social integration and daily living activities. Results: Over a median (Interquartile Range) follow-up of 189 (182-205) days, [EG = 188 (182-202), CG = 189 (182-209)] fallers were 10 in the CG and 11 in the EG (hazard ratio 0.95, 95% confidence interval (CI) 0.45 to 2.5; P = 0.94). At follow-up the EG scored significantly better than CG on the CIQ (+1.7 points, CI: 0.1 to 3.3) and IADL (+2.2 points, CI: 0.4 to 4.0). Conclusions: This educational program did not reduce the risk of falls but it improved the ability to carry out activities of daily living and decreased participation restrictions in people with neurological conditions.

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.

Ultrasound to depict anatomical abnormality: an example of potential alliance of rehabilitation professionals.

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Robotic and Sensor Technology for Upper Limb Rehabilitation.

Robotic and sensor-based neurologic rehabilitation for the upper limb is an established concept for motor learning and is recommended in many national guidelines. The complexity of the human hands and arms and the different activities of daily living are leading to an approach in which robotic and sensor-based devices are used in combination to fulfill the multiple requirements of this intervention. A multidisciplinary team of the Fondazione Don Carlo Gnocchi (FDG), an Italian nonprofit foundation, which spans across the entire Italian territory with 28 rehabilitation centers, developed a strategy for the implementation of robotic rehabilitation within the FDG centers. Using an ad hoc form developed by the team, 4 robotic and sensor-based devices were identified among the robotic therapy devices commercially available to treat the upper limb in a more comprehensive way (from the shoulder to the hand). Encouraging results from a pilot study, which compared this robotic approach with a conventional treatment, led to the deployment of the same set of robotic devices in 8 other FDG centers to start a multicenter randomized controlled trial. Efficiency and economic factors are just as important as clinical outcome. The comparison showed that robotic group therapy costs less than half per session in Germany than standard individual arm therapy with equivalent outcomes. To ensure access to high-quality therapy to the largest possible patient group and lower health care costs, robot-assisted group training is a likely option.

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.

Efficacy of Robotic-Assisted Gait Training in chronic stroke patients: Preliminary results of an Italian bi-centre study.

BACKGROUND: The gait recovery is a realist goal in the rehabilitation of almost Stroke patients. Over the last years, the introduction of robotic technologies in gait rehabilitation of stroke patients has had a greatest interest. OBJECTIVE: The aim of this study was to evaluate efficacy of Robotic Gait Training (RGT) in chronic stroke patients. METHODS: Fourteen chronic stroke patients were divided into two groups. Six patients received RGT, eight patients received traditional gait rehabilitation. Patients were assessed with clinical scales, as well as with gait analysis, at the beginning and at the end of the treatment. RESULTS: Significant changes in some clinical scales for both the groups were detected. In the robotic group, patients showed higher percentage changes in the MRC scale (p = 0.020), in the 6MWT (p = 0.043) and in the Ashworth scale (hip: p = 0.008; knee: p = 0.043; ankle: p = 0.043) when compared with the traditional group. With respect to the gait analysis, we did not found any difference neither in the within-group analysis, nor in the between-group analysis. CONCLUSIONS: Both rehabilitation treatments do not change the compensatory strategies in chronic patients but the RGT offers to the patients a more intensive and controlled gait training increasing the gait endurance and decreasing spasticity in the lower limb.

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.