Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial.

OBJECTIVE: To compare the efficacy and safety of MT10107 (Coretox) with those of onabotulinum toxin A (Botox) in patients with poststroke upper limb spasticity DESIGN: Prospective, randomized, double-blind, active drug-controlled, multicenter, phase III clinical trial. SETTING: Seven university hospitals in the Republic of Korea. PARTICIPANTS: Patients (N=220) with poststroke upper limb spasticity. INTERVENTIONS: All participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group). MAIN OUTCOME MEASURES: The primary outcome was change in wrist flexor spasticity from baseline to week 4, which was assessed using the modified Ashworth scale (MAS). The secondary outcomes were MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment. Safety was evaluated based on adverse events, vital signs, physical examination findings, and laboratory test results. The efficacy and safety were evaluated at 4, 8, and 12 weeks postintervention. RESULTS: The primary outcome was found to be -1.32±0.69 and -1.40±0.69 for the Coretox and Botox groups, respectively. MT10107 showed a non-inferior efficacy compared with onabotulinum toxin A, as the 95% confidence interval for between-group differences was -0.10 to 0.27 and the upper limit was less than the non-inferiority margin of 0.45. Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference. No significant between-group differences were observed regarding response rate, global assessment of treatment, and safety measures. CONCLUSIONS: MT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in poststroke upper limb spasticity treatment.

Effects of Electromechanical Exoskeleton-Assisted Gait Training on Walking Ability of Stroke Patients: A Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy of electromechanical exoskeleton-assisted gait training on walking ability of stroke patients based on ambulatory function, muscle strength, balance, gait speed, and capacity. DESIGN: Randomized controlled trial. SETTING: University rehabilitation hospital. PARTICIPANTS: Individuals (N=40) with stroke who could stand alone. INTERVENTIONS: Patients were randomly assigned to control and experimental groups. The control group underwent physical therapist-assisted gait training by conventional method. The experimental group underwent electromechanical gait training assisted by an exoskeleton device. Both types of gait training were performed for 30 minutes each day. The therapeutic interventions were provided for 5 days a week for a period of 4 weeks in both groups. MAIN OUTCOME MEASURES: Functional ambulatory category (FAC) before and after gait training. Changes in FAC were the primary outcomes to evaluate the efficacy of electromechanical exoskeleton-assisted gait training. Changes in mobility, walking speed, walking capacity, leg muscle strength, daily activity, and balance were secondary outcomes. RESULTS: FAC in the control group was 2.44±1.55 in the pretraining and 2.75±1.53 in the post-training. FAC in the experimental group was 3.22±1.31 in the pretraining and 3.78±1.44 in the post-training. Although FAC between pre- and post-training sessions improved in both groups, the changes in FAC were statistically significant in the experimental group alone. Most secondary outcomes in both groups also showed improvement after gait training. However, the differential outcomes were not varied between the 2 groups after adjusting the data for age and stroke duration. We did not exclude patients based on time since stroke onset. The average stroke duration was 530.11±389.21 days in the experimental group. The changes in FAC of the experimental group were negatively correlated with stroke duration. No adverse events were noticed during gait training in either group. CONCLUSIONS: Electromechanical exoskeleton-assisted gait training is as effective as conventional gait training by a physical therapist when administered by a gait trainer. As an overground walking system without harness, electromechanical exoskeleton replaced a physical therapist in assisted gait training for patients who stand alone. Because the ambulatory function of stroke patients was affected negatively by stroke duration, the effect of electromechanical-assisted gait training might decline with increased stroke duration.

Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases.

BACKGROUND: Medical device adverse event reporting is an essential activity for mitigating device-related risks. Reporting of adverse events can be done by anyone like healthcare workers, patients, and others. However, for an individual to determine the reporting, he or she should recognize the current situation as an adverse event. The objective of this report is to share observed individual differences in the perception of a medical device adverse event, which may affect the judgment and the reporting of adverse events. METHODS: We trained twenty-three participants from twelve Asia-Pacific Economic Cooperation (APEC) member economies about international guidelines for medical device vigilance. We developed and used six virtual cases and six questions. We divided participants into six groups and compared their opinions. We also surveyed the country's opinion to investigate the beginning point of 'patient use'. The phases of 'patient use' are divided into: 1) inspecting, 2) preparing, and 3) applying medical device. RESULTS: As for the question on the beginning point of 'patient use,' 28.6%, 35.7%, and 35.7% of participants provided answers regarding the first, second, and third phases, respectively. In training for applying international guidelines to virtual cases, only one of the six questions reached a consensus between the two groups in all six virtual cases. For the other five questions, different judgments were given in at least two groups. CONCLUSION: From training courses using virtual cases, we found that there was no consensus on 'patient use' point of view of medical devices. There was a significant difference in applying definitions of adverse events written in guidelines regarding the medical device associated incidents. Our results point out that international harmonization effort is needed not only to harmonize differences in regulations between countries but also to overcome diversity in perspectives existing at the site of medical device use.

Robot-assisted gait training (Lokomat) improves walking function and activity in people with spinal cord injury: a systematic review.

Robot-assisted gait training (RAGT) after spinal cord injury (SCI) induces several different neurophysiological mechanisms to restore walking ability, including the activation of central pattern generators, task-specific stepping practice and massed exercise. However, there is no clear evidence for the optimal timing and efficacy of RAGT in people with SCI. The aim of our study was to assess the effects of RAGT on improvement in walking-related functional outcomes in patients with incomplete SCI compared with other rehabilitation modalities according to time elapsed since injury. This review included 10 trials involving 502 participants to meta-analysis. The acute RAGT groups showed significantly greater improvements in gait distance, leg strength, and functional level of mobility and independence than the over-ground training (OGT) groups. The pooled mean difference was 45.05 m (95% CI 13.81 to 76.29, P = 0.005, I2 = 0%; two trials, 122 participants), 2.54 (LEMS, 95% CI 0.11 to 4.96, P = 0.04, I2 = 0%; three trials, 211 participants) and 0.5 (WISCI-II and FIM-L, 95% CI 0.02 to 0.98, P = 0.04, I2 = 67%; three trials, 211 participants), respectively. In the chronic RAGT group, significantly greater improvements in speed (pooled mean difference = 0.07 m/s, 95% CI 0.01 to 0.12, P = 0.01, I2 = 0%; three trials, 124 participants) and balance measured by TUG (pooled mean difference = 9.25, 95% CI 2.76 to 15.73, P = 0.005, I2 = 74%; three trials, 120 participants) were observed than in the group with no intervention. Thus, RAGT improves mobility-related outcomes to a greater degree than conventional OGT for patients with incomplete SCI, particularly during the acute stage. RAGT treatment is a promising technique to restore functional walking and improve locomotor ability, which might enable SCI patients to maintain a healthy lifestyle and increase their level of physical activity. TRIAL REGISTRATION: PROSPERO (CRD 42016037366 ). Registered 6 April 2016.

Prefrontal Cortex Activation during Memory Training by Virtual Drum Beating: A Randomized Controlled Trial.

The use of virtual reality (VR) content in neurological disorders with cognitive impairment is increasing. We have developed a device that incorporates virtual drum beating content, designed for digit memorization training. This study aimed to investigate the effects of realistic cognitive training on brain activity using functional near-infrared spectroscopy (fNIRS). Thirty healthy individuals were recruited and randomly assigned into two groups: conventional cognitive exercise (CCE) and a realistic cognitive exergame (RCE). Subjects in the CCE group underwent memory training by memorizing numbers displayed on a computer screen and then writing them on paper. The main outcome measure was the oxyhemoglobin level in the dorsolateral prefrontal cortex (DLPFC). As a result, the average number of digits was 7.86 ± 0.63 for the CCE and 7.6 ± 0.82 for the RCE. The mean difference in ΔHbO was 1.417 ± 0.616 µm (p = 0.029) in channel 2, located in the right DLPFC. Channel 7 and channel 10, which measured activations in the hypothesized medial orbitofrontal cortex (OFC), also showed a significant mean difference of ΔHbO. DLPFC and OFC presented higher activation in the RCE group (p < 0.05), attributable to the simultaneous memory training and virtual drum beating, which provided various sensory inputs (visual, auditory, and vibration). Although DLPFC involvement in cognitive processes remains controversial, our findings suggest that realistic memory training using drumming content can lead to safer activation of the DLPFC compared to conventional cognitive training.

Comparison of the Effects of Botulinum Toxin Doses on Nerve Regeneration in Rats with Experimentally Induced Sciatic Nerve Injury.

This study was designed to compare the effects of various doses of botulinum neurotoxin A (BoNT/A) on nerve regeneration. Sixty-five six-week-old rats with sciatic nerve injury were randomly allocated to three experimental groups, a control group, and a sham group. The experimental groups received a single session of intraneural BoNT/A (3.5, 7.0, or 14 U/kg) injection immediately after nerve-crushing injury. The control group received normal intraneural saline injections after sciatic nerve injury. At three, six, and nine weeks after nerve damage, immunofluorescence staining, an ELISA, and toluidine blue staining was used to evaluate the regenerated nerves. Serial sciatic functional index analyses and electrophysiological tests were performed every week for nine weeks. A higher expression of GFAP, S100ß, GAP43, NF200, BDNF, and NGF was seen in the 3.5 U/kg and 7.0 U/kg BoNT/A groups. The average area and myelin thickness were significantly greater in the 3.5 U/kg and 7.0 U/kg BoNT/A groups. The sciatic functional index and compound muscle action potential amplitudes exhibited similar trends. These findings indicate that the 3.5 U/kg and 7.0 U/kg BoNT/A groups exhibited better nerve regeneration than the 14 U/kg BoNT/A and control group. As the 3.5 U/kg and the 7.0 U/kg BoNT/A groups exhibited no statistical difference, we recommend using 3.5 U/kg BoNT/A for its cost-effectiveness.

A Lesson from a Measles Outbreak among Healthcare Workers in a Single Hospital in South Korea: The Importance of Knowing the Prevalence of Susceptibility.

BACKGROUND: Despite the high vaccination coverage rate, in-hospital transmission of measles continues to occur in South Korea. We present a measles outbreak in which two healthcare workers (HCWs) with presumptive evidence of measles immunity were infected by a patient with typical measles at a single hospital in South Korea. This facilitated the evaluation of measles seroprevalence in all HCWs. METHODS: In 2018, suspected patients and contacts exposed during a measles outbreak were investigated based on their medical histories and vaccination status. Cases were confirmed by the detection of measles-specific immunoglobulin M or RNA. After the measles outbreak in 2018, measles IgG testing was conducted on a total of 972 HCWs for point-prevalence, including those exposed to the measles. In addition, we have routinely performed measles IgG tests on newly employed HCWs within one week of their hire date since 2019. The measles vaccine was administered to HCWs who tested negative or equivocally negative for IgG antibodies. RESULTS: An index patient who returned from China with fever and rash was diagnosed with measles at a hospital in Korea. Two additional HCWs were revealed as measles cases: one was vaccinated with the two-dose measles-mumps-rubella (MMR) vaccine, and the other, who was born in 1967, was presumed to have immunity from natural infection in South Korea. All three patients harbored the same D8 genotype. No additional measles cases were identified among the 964 contacts of secondary patients. A total of 2310 HCWs, including those tested during the 2018 outbreak, underwent measles IgG tests. The average age at the time of the test was 32.6 years, and 74.3% were female. The overall seropositivity of measles was 88.9% (95% confidence interval, 87.5-90.1). Although the birth cohorts between 1985 and 1994 were presumed to have received the measles-rubella (MR) catch-up vaccination in 2001, 175 (89.3%) HCWs were born after 1985 among the 195 seronegative cases. CONCLUSION: Despite high population immunity, imported measles transmission occurred among HCWs with presumed immunity. This report underscores the importance of understanding the prevalence of measles susceptibility among newly employed HCWs. This is important for policymaking regarding hospital-wide vaccinations to prevent the spread of vaccine-preventable diseases.

Early Neurodevelopmental Assessments of Neonates Discharged From the Neonatal Intensive Care Unit: A Physiatrist's Perspective.

The survival rate of children admitted in the neonatal intensive care unit (NICU) after birth is on the increase; hence, proper evaluation and care of their neurodevelopment has become an important issue. Neurodevelopmental assessments of individual domains regarding motor, language, cognition, and sensory perception are crucial in planning prompt interventions for neonates requiring immediate support and rehabilitation treatment. These assessments are essential for identifying areas of weakness and designing targeted interventions to improve future functional outcomes and the quality of lives for both the infants and their families. However, initial stratification of risk to select those who are in danger of neurodevelopmental disorders is also important in terms of cost-effectiveness. Efficient and robust functional evaluations to recognize early signs of developmental disorders will help NICU graduates receive interventions and enhance functional capabilities if needed. Several age-dependent, domain-specific neurodevelopmental assessment tools are available; therefore, this review summarizes the characteristics of these tools and aims to develop multidimensional, standardized, and regular follow-up plans for NICU graduates in Korea.

Comparison of high-intensive and low-intensive electromechanical-assisted gait training by Exowalk® in patients over 3-month post-stroke.

BACKGROUND: This study was conducted to assess the effect of electromechanical-assisted gait training intensity on walking ability in patients over 3-month post-stroke. METHODS: Data from two randomized controlled trials (RCTs) were collected under the same study design of assessment and intervention, excluding intervention time per session. After matching the inclusion criteria of two RCTs, the experimental groups of each RCT were defined as low-intensive (LI) and high-intensive (HI) group according to the intervention time per session. Primary outcome was the difference of the change in Functional Ambulatory Categories (FAC) between LI and HI gait training. Secondary outcomes were the difference of changes in mobility, walking speed, walking capacity, leg-muscle strength, balance and daily activity evaluated with Rivermead Mobility Index (RMI), 10 m walk test (10MWT), 6-min walk test (6MWT), Motricity Index (MI), Berg Balance Scale (BBS) and Modified Barthel Index (MBI) respectively. RESULTS: The FAC improved after gait training in both groups. The secondary outcomes also improved in both groups except RMI and MI in HI group. The change of all outcomes were not different between groups except RMI. The change of RMI in the LI group was greater than that in the HI group statistically, but it did not meet minimal clinically important difference. CONCLUSIONS: The improvement of walking ability after LI or HI gait training was not different if providing the same total gait training time. By providing the electromechanical gait training intensively, we could shorten the gait training period to improve walking ability and customize the training program according to the patient training abilities. TRIAL REGISTRATION: Name of the registry: Clinical Research Information Service. TRIAL REGISTRATION NUMBER: No. KCT0002195(RCT1), No. KCT0002552(RCT2). Date of registration: 10/04/2016(RCT1), 10/05/2017(RCT2). URL of the trial registry record: https://cris.nih.go.kr/cris/search.

Efficacy and safety of EXOWALK® on electromechanical-assisted gait training: study protocol for randomized controlled trial.

BACKGROUND: High-intensity repetitive task-specific practice might be the most effective strategy to promote motor recovery after stroke, and electromechanical-assisted gait training represents one of the treatment options. However, there is still difficulty in clarifying the difference between conventional gait training and electromechanically assisted gait training. METHODS: The study is a multicenter, randomized, parallel-group clinical trial for stroke patients. Three clinical research centers in Korea (Dongguk University Ilsan Hospital, Chungnam National University Hospital, and Seoul National University Bundang Hospital) will participate in the clinical trial and 144 stroke patients will be registered. Enrolled patients are assigned to two groups, an experimental group and a control group, according to a randomization table. In addition, patients are treated for half an hour (one session) five times a week for 4 weeks. Both groups carry out basic rehabilitation (central nervous system development therapy and strength exercise) and the experimental group executes robotic walking rehabilitation treatment, and the control group executes conventional gait rehabilitation treatment. The primary endpoint variable is the Functional Ambulation Category (FAC) that determines the degree of independent walking and is measured before, after, and after 4 weeks of treatment. Secondary endpoint variables are 11 variables that take into account motor function and range, measured at the same time as the primary endpoint variable. DISCUSSION: There are still insufficient data on the effectiveness of electromechanical-assisted gait training for stroke patients and large-scale research is lacking. Thus, the research described here is a large-scale study of stroke patients that can supplement the limitations mentioned in other previous studies. In addition, the clinical studies described here include physical epidemiological analysis parameters that can determine walking ability. The results of this study can lead to prove the generalizable effectiveness and safety of electromechanical-assisted gait training with EXOWALK®. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea KCT0003411, Registered on 30 October 2018.

Which Health Impacts of Medical Device Adverse Event Should Be Reported Immediately in Korea?

OBJECTIVE: Immediate medical device adverse event (MDAE) reporting indications of Korea include death, life-threatening, hospitalization (initial or prolonged), disability or permanent damage, and congenital malformation or abnormalities. With the advent of new codes from the International Medical Device Regulators Forum, a study was undertaken to explore the applicability of health impact codes as immediate MDAE reporting indications in the Republic of Korea. METHOD: This domestic cross-sectional survey study was conducted for members from Medical Device Safety Information Monitoring Center in November 2019. For the annex F (health impact) codes defining health impact of an MDAE, we checked whether each code matched with the current indication and asked experts whether they agreed with each code as an indication of immediate reporting. Consensus was reached when ≥70% of experts agreed. RESULTS: A total of 28 experts from 19 centers responded to the survey. Of a total of 64 codes, 29 matched with the current indication. However, in an expert survey, 17 of 29 codes were not agreed for immediate reporting and 5 codes were found to be unmatched codes. For these 5 codes, experts agreed that they would need reporting immediately. Finally, only 17 codes achieved consensus for immediate reporting. CONCLUSIONS: There is a discrepancy between the code matched to the current immediate MDAE reporting indication and experts' consensus. Sufficient discussion and agreement would be needed to apply health impact codes for immediate reporting.

Efficacy of electromechanical-assisted gait training on clinical walking function and gait symmetry after brain injury of stroke: a randomized controlled trial.

Electromechanical-assisted gait training may be an effective intervention to promote motor recovery after brain injury. However, many studies still have difficulties in clarifying the difference between electromechanical-assisted gait training and conventional gait training. To evaluate the effectiveness of electromechanical-assisted gait training compared to that of conventional gait training on clinical walking function and gait symmetry of stroke patients. We randomly assigned patients with stroke (n = 144) to a control group (physical therapist-assisted gait training) and an experimental group (electromechanical gait training). Both types of gait training were done for 30 min each day, 5 days a week for 4 weeks. The primary endpoint was the change in functional ambulatory category (FAC). Secondary endpoints were clinical walking functions and gait symmetries of swing time and step length. All outcomes were measured at baseline (pre-intervention) and at 4 weeks after the baseline (post-intervention). FAC showed significant improvement after the intervention, as did clinical walking functions, in both groups. The step-length asymmetry improved in the control group, but that in the experimental group and the swing-time asymmetry in both groups did not show significant improvement. In the subgroup analysis of stroke duration of 90 days, FAC and clinical walking functions showed more significant improvement in the subacute group than in the chronic group. However, gait symmetries did not show any significant changes in either the subacute or the chronic group. Electromechanically assisted gait training by EXOWALK was as effective as conventional gait training with a physiotherapist. Although clinical walking function in the subacute group improved more than in the chronic group, gait asymmetry did not improve for either group after gait training.Trial registration: KCT0003411 Clinical Research Information Service (CRIS), Republic of Korea.

Efficacy and Safety of Botulinum Toxin Type A (NABOTA) for Post-stroke Upper Extremity Spasticity: A Multicenter Phase IV Trial.

OBJECTIVE: To evaluate the efficacy and safety of Daewoong botulinum toxin type A (NABOTA) after its launch in South Korea. METHODS: This prospective, multicenter, open-label phase IV clinical trial included 222 patients with stroke. All patients visited the clinic at baseline and at weeks 4, 8, and 12 after injection of upto 360 units of NABOTA into the wrist, elbow, and finger flexor muscles at the first visit. The primary outcome was the change in Modified Ashworth Scale (MAS) score for the wrist flexor muscles between baseline and week 4. The secondary outcomes were the changes in MAS, Disability Assessment Scale (DAS), and Caregiver Burden Scale (CBS) scores between baseline and each visit, and the Global Assessment Scale (GAS) score at week 12. RESULTS: There was a statistically significant decrease in the MAS score for the wrist flexors between baseline and week 4 (-0.97±0.66, p<0.001). Compared with baseline, the MAS, DAS and CBS scores improved significantly during the study period. The GAS was rated as very good or good by 86.8% of physicians and by 60.0% of patients (or caregivers). The incidence of adverse events was 14.4%, which is smaller than that in a previous trial. CONCLUSION: NABOTA showed considerable efficacy and safety in the management of upper limb spasticity in stroke patients.

Neuronox versus BOTOX for spastic equinus gait in children with cerebral palsy: a randomized, double-blinded, controlled multicentre clinical trial.

AIM: The aim of this study was to evaluate the efficacy and safety of a newly manufactured botulinum toxin, Neuronox, compared with BOTOX for the treatment of the spastic equinus gait in children with cerebral palsy. METHOD: A total of 127 children with cerebral palsy, aged 2 to 10 years, who presented at three university hospitals with spastic equinus gait were assessed for eligibility to participate in this double-blinded, randomized, controlled trial. Of the 119 eligible participants (mean age 4.33 y; SD 2.07; 76 males and 43 females; 79 with diplegia and 40 with hemiplegia), 57 were classified as Gross Motor Function Classification System level I, 29 as level II, and 33 as level III. Participants were randomly assigned to receive an injection of Neuronox (n=60) or BOTOX (n=59) to the calf muscles at a dose of 4U/kg for those with hemiplegia and 6U/kg for those with diplegia. Assessments were performed at baseline (V1) and at 4 (V2), 12 (V3), and 24 (V4) weeks after the intervention. The primary outcome measure was response rate at V3, with a positive response being defined as at least a 2-point increase in the Physicians' Rating Scale (PRS) score. The non-inferiority margin was set as -20% for the difference in the response rate. The secondary outcome measures included PRS score, passive range of motion (PROM) of the ankle and knee, and Gross Motor Function Measure 88 (GMFM-88). Any adverse events were investigated for safety implications. RESULTS: The response rate of the Neuronox group at V3 was not inferior to that of the BOTOX group (90% lower limit=-11.58%). There were significant improvements in PRS, PROM of ankle dorsiflexion, and GMFM scores at V2, V3, and V4 in both groups. The changes in PRS score were not statistically different between the two groups in serial evaluation (p=0.96). PROM of the ankle dorsiflexion increased without any significant difference between the two groups, either overall (p=0.56) or at each visit (V2, p=0.32; V3, p=0.66; V4, p=0.90). The increase in GMFM score in serial measurements were not significantly different between the two groups (p=0.16), whereas it was larger in the BOTOX group than in the Neuronox group at V2 and V4 (p=0.03 and 0.05 respectively). The frequency of adverse events was not significantly different between the two groups (p=0.97), and drug-related complications of Neuronox treatment were not addressed. INTERPRETATION: The outcomes of Neuronox, based on PRS, proved to be as effective and safe as those of BOTOX for the treatment of spasticity in individuals with cerebral palsy.

Benefits and Feasibility of Using Videos to Assess Medical School Applicants' Empathetic Abilities in Multiple Mini Interviews.

Purpose: We sought to evaluate the feasibility and benefits of using video-based scenarios in Multiple Mini Interviews (MMIs) to assess candidate's empathic abilities by investigating candidate perceptions and the acceptability, fairness, reliability, and validity of the test. Methods: The study sample was candidates for admission interviews held in the MMI format at a medical school in South Korea. In this six-station MMI, one station included a 2-min video clip of a patient-doctor communication scenario to assess candidate emphatic abilities, whereas paper-based scenarios were used in the other stations. Candidate's perceptions and acceptability of using the video-based scenario in the empathy station were examined using a 41-item post-MMI questionnaire. Fairness of the test was assessed by means of differences in candidate perceptions and performance across different demographics or backgrounds. Construct validity was assessed by examining the relationship of candidate performances in the empathy station with those in other stations. The G-coefficient was analyzed to estimate the reliability of the test. Results: Eighty-two questionnaires were returned, a 97.6% response rate. Candidates showed overall positive perceptions of the video-based scenario and they found it authentic and interesting. The test was fair as there were no differences in candidates' perceptions of the patient-doctor relationship presented in the video clip and neither in their performance nor in their perceived difficulty of the station across demographics or backgrounds. Construct validity was established as candidate performance in the empathy station was not associated with that of any other stations. The G-coefficient was 0.74. Conclusions: The present study demonstrates that the video-based scenario is a feasible tool to assess candidate's empathy in the MMI.

Effect of Botulinum Toxin Injection and Extracorporeal Shock Wave Therapy on Nerve Regeneration in Rats with Experimentally Induced Sciatic Nerve Injury.

This study was designed to compare the roles of botulinum neurotoxin A (BoNT/A) and extracorporeal shock wave therapy (ESWT) in promoting the functional recovery and regeneration of injured peripheral nerves. A total of 45 six-week-old rats with sciatic nerve injury were randomly divided into two experimental groups and one control group. The experimental groups received a single session of intranerve BoNT/A or ESWT immediately after a nerve-crushing injury. The control group was not exposed to any treatment. Differentiation of Schwann cells and axonal sprouting were observed through immunofluorescence staining, ELISA, real-time PCR, and Western blot at 3, 6, and 10 weeks post-nerve injury. For clinical assessment, serial sciatic functional index analysis and electrophysiological studies were performed. A higher expression of GFAP and S100ß was detected in injured nerves treated with BoNT/A or ESWT. The levels of GAP43, ATF3, and NF200 associated with axonal regeneration in the experimental groups were also significantly higher than in the control group. The motor functional improvement occurred after 7 weeks of clinical observation following BoNT/A and ESWT. Compared with the control group, the amplitude of the compound muscle action potential in the experimental groups was significantly higher from 6 to 10 weeks. Collectively, these findings indicate that BoNT/A and ESWT similarly induced the activation of Schwann cells with the axonal regeneration of and functional improvement in the injured nerve.

The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience.

Medical devices may revolutionize healthcare delivery but can lead to serious adverse events for treated patients and users. While reporting of adverse events related to medical devices is an essential starting point for post-market surveillance, underreporting of medical device adverse events is a global problem. Korea introduced a voluntary medical device adverse event reporting system in 2010, called the Medical Device Safety Information Monitoring Center, which has led to an increase in adverse event reports. For 10 years, the Medical Device Safety Information Monitoring Center has analyzed medical device adverse events systematically and has provided active feedback to the manufacturers and education on safe use. Recently, the Medical Device Safety Information Monitoring Center contributed to harmonization of international medical device vigilance through the sharing of adverse events. This experience of Korea might contribute to improvements in medical device vigilance, which is a critical prerequisite for improving medical device policies and regulations.

Efficacy of Electromechanically-Assisted Rehabilitation of Upper Limb Function in Post-Stroke Patients: A Randomized Controlled Study.

OBJECTIVE: To investigate the efficacy of electromechanically-assisted rehabilitation of upper limb function in post-stroke patients. DESIGN: Randomized controlled trial. SUBJECTS: Forty-eight stroke patients. METHODS: Patients were randomly assigned to control and experimental groups. The control group underwent occupational therapy training with conventional methods. The experimental group underwent electromechanically-assisted training using an end effector robot (Camillo®). Interventions were provided for 30 min per day, 5 days a week, for 4 weeks. Primary outcome was change in Fugl-Meyer Assessment (FMA) before and after training. Secondary outcomes were changes in hand function, upper limb strength, spasticity, mental status and quality of life. RESULTS: Mean improvement in FMA was 1.17 (standard deviation (SD) 4.18) in the control group and 2.52 (SD 5.48) in the experimental group. Although FMA in the experimental group improved significantly after training, the improvement in FMA did not differ significantly between groups. Among the secondary outcomes, the Motricity Index (MI) improved significantly after training in the experimental group, and the change in MI between groups was statistically significant. CONCLUSION: Electromechanically-assisted rehabilitation using Camillo® was not more effective than conventional occupation therapy for upper arm function.

Isolated Oculomotor Nerve Palsy in Mild Traumatic Brain Injury.

BACKGROUND: Isolated oculomotor nerve palsy is rarely encountered after mild traumatic brain injury. It is difficult to offer patients accurate management strategies or prognostic assessments because only a few reports have described the management of oculomotor nerve palsy. METHODS: We performed a search for all clinical studies of isolated oculomotor nerve palsy after mild traumatic brain injury published up to July 9, 2019. We placed no restrictions on language or year of publication in our search, and we searched the following key words: traumatic brain injury, isolated oculomotor nerve palsy, mild head trauma, management, and prognosis. RESULTS: We identified 14 cases of isolated oculomotor nerve palsy after mild traumatic brain injury. In three cases, steroids were used to manage the oculomotor nerve palsy. Five patients who had underlying brain lesions underwent surgery, and seven patients were observed and followed up. The time to partial or complete resolution was 6.0 ± 5.3 mos with a range of 0.5-18 mos. CONCLUSIONS: This review includes a survey of surgical treatment for the management of traumatic brain injury that underlies oculomotor nerve palsies, steroid therapy to reduce related brain edema, and oculomotor rehabilitation with training eye movement behavior.

Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex for Motor Recovery in Subacute Ischemic Stroke: A Randomized Sham-Controlled Trial.

BACKGROUND: Low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1) has demonstrated beneficial effects on motor recovery, but evidence among patients with subacute stroke is lacking. We aimed to investigate whether 1-Hz rTMS over the contralesional M1 versus sham rTMS could improve arm function in patients with subacute ischemic stroke when combined with rehabilitative motor training. METHODS: In total, 77 patients who were within 90 days after their first-ever ischemic stroke were enrolled and randomly allocated to either real (n = 40) or sham rTMS (n = 37). We delivered 1-Hz 30-minute active or sham rTMS before each daily 30-minute occupational therapy sessions over a 2-week period. The primary endpoint was changes in the Box and Block Test (BBT) score immediately after the end of treatment (EOT). Secondary analyses assessed changes in Fugl-Meyer assessment, Finger Tapping Test (FTT), Brunnstrom stage, and grip strength. CLINICAL TRIAL REGISTRATION: ClinialTrials.gov (NCT02082015). RESULTS: Changes in BBT immediately after the end of treatment did not differ significantly between the 2 groups (P = .267). Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham; P = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham; P = .023), only in the group without cortical involvement. CONCLUSION: The effects of real and sham rTMS did not differ significantly among patients within 3 months poststroke. The location of stroke lesions should be considered for future clinical trials.