A Randomized, Double-Blind, Active Control, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Liztox® versus Botox® in Post-Stroke Upper Limb Spasticity.

Botulinum toxin type A (BTX-A) injection is a commonly used therapeutic intervention for upper limb spasticity in stroke patients. This study was designed as a randomized, active-drug-controlled, double-blind, multicenter, phase 3 clinical trial to evaluate the safety and efficacy of Liztox® in comparison to onabotulinum toxin A (Botox®) for individuals with post-stroke upper limb spasticity. The primary outcome was the alteration in wrist flexor muscle tone from the initial assessment to the fourth week, evaluated using the modified Ashworth scale (MAS). Secondary outcomes included MAS score changes for the wrist at weeks 8 and 12 from baseline; MAS score changes for finger and elbow flexors; and changes in the Disability Assessment Scale (DAS), Subject's Global Assessment (SGA), the Investigator's Global Assessment (IGA), and Caregiver Burden Scale (CBS) at weeks 4, 8, and 12 from baseline. The MAS score for wrist flexor spasticity decreased by -1.14 ± 0.59 in the Liztox® group and -1.22 ± 0.59 in the Botox® group from baseline to week 4. The difference [97.5% confidence interval (CI)] between the test and control groups was 0.08 [-∞, 0.26], confirming the non-inferiority of the test group compared to the control group. Furthermore, there were consistent improvements in the IGA, SGA, and CBS scores across all assessment intervals, with no statistically significant variances detected between the two groups. No safety-related concerns were reported during the study. In conclusion, Liztox® injection proved to be a secure and efficacious intervention for managing upper extremity spasticity in post-stroke patients.

Relation between Lower Urinary Tract Dysfunction and Functional Outcome in Patients After Brain Tumor Resection.

This study aimed to compare functional outcomes after rehabilitation with initial degree of urinary retention (UR) in patients operated on for brain tumors. Medical records of 61 patients transferred to the Department of Rehabilitation Medicine of single center, from January 2011 to December 2021, were reviewed retrospectively. Patient data included post-void residual (PVR) urine, tumor characteristics, and functional status. Functional status was evaluated on the Mini-Mental Status Examination (MMSE), Modified Barthel Index (MBI), Functional Ambulation Category (FAC), Modified Rankin Scale (mRS), Motricity Index (MI)-lower limb, and Berg Balance Scale (BBS). MMSE, FAC, mRS, and MI-lower limb were re-evaluated 3 weeks after standard inpatient rehabilitation. Twenty-four patients were in the UR group and 37 in the non-UR group. Initial MMSE, MBI, BBS, FAC, and mRS were significantly worse in the UR group, and both groups showed significant functional improvement after rehabilitation. After rehabilitation, MMSE, FAC, MRS, MI-lower were still worse in the UR group, but the degree of improvement between the groups was not significantly different. Rehabilitation was shown to be effective for brain tumor patients regardless of UR. Initial UR after brain tumor surgery is significantly associated with poor functional status in both the early stages of rehabilitation and after rehabilitation.

Clinical Practice Guideline for Stroke Rehabilitation in Korea-Part 1: Rehabilitation for Motor Function (2022).

This clinical practice guideline (CPG) is the fourth edition of the Korean guideline for stroke rehabilitation, which was last updated in 2016. The development approach has been changed from a consensus-based approach to an evidence-based approach using the Grading of Recommendations Assessment Development and Evaluation (GRADE) method. This change ensures that the guidelines are based on the latest and strongest evidence available. The aim is to provide the most accurate and effective guidance to stroke rehabilitation teams, and to improve the outcomes for stroke patients in Korea. Fifty-five specialists in stroke rehabilitation and one CPG development methodology expert participated in this development. The scope of the previous clinical guidelines was very extensive, making it difficult to revise at once. Therefore, it was decided that the scope of this revised CPG would be limited to Part 1: Rehabilitation for Motor Function. The key questions were selected by considering the preferences of the target population and referring to foreign guidelines for stroke rehabilitation, and the recommendations were completed through systematic literature review and the GRADE method. The draft recommendations, which were agreed upon through an official consensus process, were refined after evaluation by a public hearing and external expert evaluation.

Effects of Training with a Powered Exoskeleton on Cortical Activity Modulation in Hemiparetic Chronic Stroke Patients: A Randomized Controlled Pilot Trial.

OBJECTIVES: To investigate the effects of exoskeleton-assisted gait training in stroke patients. DESIGN: Prospective randomized controlled trial. SETTING: Rehabilitation department in a single tertiary hospital. PARTICIPANTS: Thirty (N=30) chronic stroke patients with Functional Ambulatory Category scale (FAC) between 2 and 4. INTERVENTION: Patients were randomly assigned to 1 of 2 groups: training with Healbot G, a wearable powered exoskeleton (Healbot G group; n=15), or treadmill training (control group; n=15). All participants received 30 minutes of training, 10 times per week, for 4 weeks. OUTCOME MEASUREMENTS: The primary outcome was oxyhemoglobin level changes, representing cortical activity in both motor cortices using functional near-infrared spectroscopy. The secondary outcomes included FAC, Berg Balance Scale, Motricity Index for the lower extremities (MI-Lower), 10-meter walk test, and gait symmetry ratio (spatial step and temporal symmetry ratio). RESULTS: Compared to the control group, during the entire training session, the pre-training and post-training mean cortical activity, and the amount of increment between pre- and post-training were significantly higher in the Healbot G group (∆mean ± SD; pre-training, 0.245±0.119, post-training, 0.697±0.429, between pre- and post-training, 0.471±0.401µmol, P<.001). There was no significant difference in cortical activity between affected- and unaffected hemispheres after Healbot G training. FAC (∆mean ± SD; 0.35 ± 0.50, P=.012), MI-Lower (∆mean ± SD; 7.01 ± 0.14, P=.001), and spatial step gait symmetry ratio (∆mean ± SD; -0.32 ± 0.25, P=.049) were improved significantly in the Healbot G group. CONCLUSION: Exoskeleton-assisted gait training induces cortical modulation effect in both motor cortices, a balanced cortical activation pattern with improvements in spatial step symmetry ratio, walking ability, and voluntary strength.

The effect of training using an upper limb rehabilitation robot (HEXO-UR30A) in chronic stroke patients: A randomized controlled trial.

BACKGROUND: Upper limb robotic rehabilitation can be beneficial to the patients when applied appropriately. HEXO-UR30A is a novel exoskeletal type upper limb rehabilitation robot that provides continuous passive motion to the shoulder joint. OBJECTIVE: The purpose of this study is to evaluate the effectiveness of HEXO-UR30A on the patient's functional change, spasticity, and range of motion (ROM). METHODS: We included stroke patients with upper limb hemiparesis of age > 19 years with spasticity grading of modified Ashworth scale < 3 and Brunnstrom recovery stage ≥ 4. The efficacy of the robot was investigated based on a rehabilitation program for 3 weeks. Patient's functions were compared before vs after treatment and between the HEXO group vs control. We conducted the Fugl-Meyer Assessment of the Upper Extremity, modified Barthel index, modified Ashworth scale, ROM, and Motricity Index upper limb. Patients' satisfaction was evaluated using a questionnaire after every 10 sessions of training. RESULTS: In the HEXO group, the Fugl-Meyer assessment for shoulder improved significantly (P value = .006*) compared with the control group (P value = .075). Both groups showed significant improvement (P value < .05) in Motricity Index upper limb after treatment. There were some improvements in the passive and active ROM. Patients in the HEXO group reported high satisfaction with upper limb rehabilitation. CONCLUSION: These results show that HEXO-UR30A can improve functional ability in chronic stroke patients. Moreover, the high satisfaction in patients might promote active involvement in upper limb rehabilitation.

The effect of a gait and balance training program on an unstable mudflats surface in older adults: A randomized controlled pilot study.

BACKGROUND: Balance training on an unstable support surface has been known to improve postural control. The aim of this study was to investigate the effect of a gait and balance training program on an unstable mudflats surface in older adults. METHODS: A total of 28 older people were assigned to participate in a gait and balance training program on an unstable mudflats surface (experimental group) or on firm ground (control group). All participants received the training program for 55 minutes per session, 2 sessions per day for 5 days. The primary outcomes were the Berg Balance Scale (BBS) and single-leg stance (SLS) test. Secondary outcomes were Timed Up and Go (TUG), 10-meter walk test (10MWT), Modified Falls Efficacy Scale (MFES), Motricity Index (MI) of the lower extremities, and medical research council (MRC) scale of lower extremities. RESULTS: SLS with eyes open and the MRC of the left and right ankles showed a large effect size whereas the MI of the left and right lower extremities and MRC of the left and right knees showed a medium effect size in the experimental group. Intergroup differences in changes from baseline to after the exercise program included a large effect size of the SLS with eye open and MI of the right lower extremity and a medium effect size of the MI of the left lower extremity and MRC of the right ankle and left hip. CONCLUSIONS: Muscle strength and balance of older people could be improved with gait and balance training on an unstable mudflat surface.

The Effect of Gait Training on a Sandy Beach in Patients with Chronic Stroke: A Randomized Controlled Pilot Study.

Background: A sandy beach provides an unstable support surface and may influence walking ability in patients with stroke. Primary Study Objective: To investigate the effect of gait training on a sandy beach in patients with chronic stroke. Methods/Design: This was a randomized controlled trial. Setting: Patients were recruited from a community center. Participants: A total of 28 patients with chronic stroke participated in the study. Intervention: Patients were randomly assigned to receive gait training either on a sandy beach (sand group) or firm ground (control group). All patients received gait training for 30 minutes per session, 2 sessions every day for 5 days. Context: Primary Outcome Measures • Primary outcomes were 10-minute walk test (10MWT) and Berg Balance Scale (BBS) scores. Secondary outcomes were Functional Ambulatory Category (FAC), Timed Up and Go (TUG) and spatiotemporal parameters of gait evaluated with a wearable inertial sensor. Psychological parameters, including the Beck Depression Inventory (BDI) and State-Trait Anxiety Inventory (STAI), were also measured. Outcome measurements were evaluated at baseline and after the intervention. Results: The 10MWT and BBS scores were significantly improved in the sand group (P < .05). Compared with the changes from pre- to post-treatment between the groups, 10MWT showed a large effect size and BBS score showed a medium effect size. Regarding spatiotemporal parameters, cadence and gait velocity were significantly higher after training than before training in the sand group (P < .05). Compared with the changes from pre- to post-treatment between groups, cadence and gait velocity showed large effect sizes and affected-side stride length showed a medium effect size. There was no difference in the changes from pre- to post-treatment in BDI and STAI between the 2 groups (P > .05). No adverse events occurred during the study. Conclusion: Gait training on a sandy beach may be beneficial for improving walking ability and balance in patients with stroke.

Safety and Efficacy of HU-014 in the Treatment of Post-Stroke Upper Limb Spasticity: A Phase I Pilot Study.

Botulinum toxin type A (BTX-A) is widely used for treating post-stroke upper limb spasticity. We evaluated the safety and efficacy of HU-014 in treating post-stroke upper limb spasticity. Thirteen patients were administered with HU-014. The primary outcome was safety, including adverse events, vital signs, physical examination, laboratory tests, and antibody formation test. The secondary outcomes were changes in the Modified Ashworth Scale (MAS) score for wrist, elbow, and finger flexor; Disability Assessment Scale (DAS); Investigator's Global Assessment (IGA) and Subject's Global Assessment (SGA); Caregiver Burden Scale (CBS); and Columbia Suicide Severity Rating Scale (C-SSRS) at weeks 4, 8, and 12 from baseline. No notable safety-related issues were reported. MAS and DAS scores were significantly decreased from those at baseline at 4, 8, and 12 weeks (p < 0.05). At weeks 4, 8, and 12, the IGA and SGA scores were 5.85 ± 0.55, 5.69 ± 0.48, and 5.62 ± 0.65 and 5.46 ± 1.20, 5.85 ± 0.38, and 5.77 ± 0.73, respectively. CBS scores decreased at all timepoints and those for cutting fingernails significantly decreased at 8 and 12 weeks compared with baseline (p < 0.05). C-SSRS scores showed that suicidal ideation in all patients was "low" at all timepoints. HU-014 is a safe treatment that can improve post-stroke upper limb spasticity.

Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial.

BACKGROUND: Botulinum toxin type A injection is widely used treatment option for the treatment of upper limb spasticity in stroke patients. The purpose of this study was to explore the safety and efficacy of MT10107, a new botulinum toxin type A, in patients with post-stroke upper limb spasticity. METHODS: A prospective, randomized, double-blind, active drug-controlled, multi-center, phase I clinical trial. Thirty patients with post-stroke upper limb spasticity were received either MT10107 or onabotulinumtoxinA. Primary endpoint was change of modified Ashworth scale (MAS) score for wrist flexor from baseline to week 4. The secondary endpoints were changes of MAS scores for elbow and finger flexors, response rate, Disability Assessment Scale (DAS), and global assessment of treatment. The safety endpoints such as adverse events, vital signs, physical examination, and laboratory test were evaluated. The outcome measures were evaluated from baseline to week 4. RESULTS: The primary endpoints were -1.07 ± 0.70 and -1.23 ± 0.56 for the MT10107 and onabotulinumtoxinA groups, respectively. The intergroup difference of change between the 2 groups was 0.17 (95% confidence interval -0.31 to 0.64, P = .5769). In secondary endpoints, both groups showed a significant improvement in both MAS and DAS. There was no significant between-group difference in all secondary endpoints and safety measures. CONCLUSION: The safety and efficacy of MT10107 showed no significant difference compared to onabotulinumtoxinA in post-stroke upper limb spasticity treatment.

Effects of a lower limb rehabilitation robot with various training modes in patients with stroke: A randomized controlled trial.

BACKGROUND: The effect of robot-assisted gait training has been demonstrated to improve gait recovery in patients with stroke. The aim of this study was to determine effects of robot-assisted gait training with various training modes in patients post stroke. METHODS: Forty-seven patients post stroke were randomly assigned to one of 4 groups: Healbot T with pelvic off mode (pelvic off group; n = 11); Healbot T with pelvic control mode (pelvic on group; n = 12); Healbot T with constraint-induced movement therapy (CIMT) mode (CIMT group; n = 10); and conventional physiotherapy (control group; n = 10). All patients received a 30-minute session 10 times for 4 weeks. The primary outcomes were the 10-meter walk test (10MWT) and Berg Balance Scale (BBS). The secondary outcomes were functional ambulation category, timed up and go (TUG), and motricity index of the lower extremities (MI-Lower). RESULTS: The pelvic off group showed significant improvements in BBS, TUG, and MI-Lower (P < .05). The pelvic on and CIMT groups showed significant improvement in 10MWT, BBS, TUG, and MI-Lower (P < .05). Compared with control group, the pelvic on group showed greater improvement in the TUG and BBS scores; the CIMT group showed greater improvement in 10MWT and MI-Lower (P < .05). CONCLUSION: This study suggested that Healbot T-assisted gait training benefited patients with stroke. The Healbot T with pelvic motion and CIMT modes were more helpful in improving balance and walking ability and lower limb strength, respectively, compared with conventional physiotherapy.

Intensity control of robot-assisted gait training based on biometric data: Preliminary study.

OBJECTIVE: This study is aimed to compare the effect of robot-assisted gait training when the intensity is controlled using patients' biometric data to when controlled by therapist's subjective judgment. DESIGN: This is non-blinded, prospective, randomized controlled study. Patients were randomly assigned to one of two groups. In biometric data control group, exercise intensity was controlled through the patient's heart rate or rating of perceived exertion (RPE). The intensity was raised to the next level when the patient's heart rate reserve was less than 40 percent or the RPE was less than 12 points. The exercise intensity of the therapist control group was adjusted according to the judgement of a therapist. All patients were instructed to perform robot (Morning Walk®)-assisted 20-minute gait training session five times a week during 3 weeks. The primary outcome was functional ambulation category (FAC). The secondary outcomes were modified Barthel index (MBI), Berg balance scale (BBS), timed up and go test (TUG) and 10-meter walk test (10MWT) The outcomes were evaluated at baseline and after 3-week gait training. RESULTS: A total of 55 patients with stroke were enrolled. After robotic rehabilitation, the primary outcome, FAC improved significantly (P < .05) in both groups. Also, secondary outcomes, including MBI, BBS, TUG, 10MWT, showed significant improvement (P < .05) in all groups. In addition, when comparing the functional change from baseline to week 3 between the two groups, there was no statistically significant difference in FAC (P > .05). The difference of baseline and week 3 of secondary outcome measure, MBI, BBS, TUG, 10MWT, showed no significant difference (P > .05). CONCLUSION: In conclusion, when the robot intensity was adjusted using the patient's heart rate or RPE, the treatment effect has no significant difference to when adjusting the intensity according to the know-how of the therapist.

Compliance and effect of thickener use in dysphagia patients with brain lesions: An observational pilot study.

The study aimed to investigate the status of thickener use in dysphagia patients with brain lesions and incidence of adverse events based on fluid viscosity. Twenty dysphagia patients with brain lesions who were recommended to use thickeners following a videofluoroscopic swallowing study were enrolled in this observational pilot study. Patients were educated to use thickener as level 2 or 3 based on the International Dysphagia Diet Standardization Initiative flow test. We evaluated the viscosity of the fluid that patients drank once a week for 2 weeks, and reviewed medical records regarding adverse events. Patients were divided into 2 groups based on the average value obtained from the viscosity evaluations as thin (Levels 0-2) and thick fluid groups (Levels 3-4). Adverse events were compared between the groups. The number of patients who did not follow the recommendations increased from 35.0 to 45.0% during the 1-week follow-up period. No patient developed pneumonia or urinary tract infection. Constipation (P = 0.338) and dehydration status (P = 0.202) were not significantly different between the 2 groups. In 2 evaluations for 20 patients, 40.0% of the cases did not follow the educated viscosity, and the number gradually increased in the follow-up evaluation. Considering that there were no significant differences in the incidence of adverse effects including pneumonia according to the fluid viscosity, a further study is necessary to establish detailed criteria for thickener use in dysphagia patients with brain lesions.

The effect of pelvic movements of a gait training system for stroke patients: a single blind, randomized, parallel study.

BACKGROUND: Aging societies lead to higher demand for gait rehabilitation as age-related neurological disorders such as stroke and spinal cord injury increase. Since conventional methods for gait rehabilitation are physically and economically burdensome, robotic gait training systems have been studied and commercialized, many of which provided movements confined in the sagittal plane. For better outcomes of gait rehabilitation with more natural gait patterns, however, it is desirable to provide pelvic movements in the transverse plane. In this study, a robotic gait training system capable of pelvic motions in the transverse plane was used to evaluate the effect of the pelvic motions on stroke patients. METHOD: Healbot T, which is a robotic gait training system and capable of providing pelvic movements in the transverse plane as well as flexion/extension of the hip and knee joints and adduction/abduction of the hip joints, is introduced and used to evaluate the effect of the pelvic movement on gait training of stroke patients. Gait trainings in Healbot T with and without pelvic movements are carried out with stroke patients having hemiparesis. EXPERIMENT: Twenty-four stroke patients with hemiparesis were randomly assigned into two groups and 23 of them successfully completed the experiment except one subject who had dropped out due to personal reasons. Pelvis-on group was provided with pelvic motions whereas no pelvic movement was allowed for pelvis-off group during 10 sessions of gait trainings in Healbot T. Electromyography (EMG) signals and interaction forces as well as the joint angles of the robot were measured. Gait parameters such as stride length, cadence, and walking speed were measured while walking on the ground without assistance of Healbot T after gait training on 1st, 5th, and 10th day. RESULT: Stride length significantly increased in both groups. Furthermore, cadence and walking speed of the pelvis-on group were increased by 10.6% and 11.8%. Although interaction forces of both groups except the thighs showed no differences, EMG signals from gluteus medius of the pelvis-on group increased by 88.6% during stance phase. In addition, EMG signals of biceps femoris, gastrocnemius medial, and gastrocnemius lateral of the pelvis-on group increased whereas EMG signals of the pelvis-off group except gastrocnemius lateral showed no difference after gait trainings. CONCLUSION: Gait training using a robotic gait training system with pelvic movements was conducted to investigate the effects of lateral and rotational pelvic movements in gait training of stroke patients. The pelvic movements affected to increase voluntary muscle activation during the stance phase as well as cadence and walking speed. CLINICAL TRIAL REGISTRATION: KCT0003762, 2018-1254, Registered 28 October 2018, https://cris.nih.go.kr/cris/search/search_result_st01_kren.jsp?seq=14310<ype=&rtype=.

The effect of robot-assisted gait training on cortical activation in stroke patients: A functional near-infrared spectroscopy study.

OBJECTIVE: To investigate the effects of the robot-assisted gait training on cortical activation and functional outcomes in stroke patients. METHODS: The patients were randomly assigned: training with Morning Walk® (Morning Walk group; n = 30); conventional physiotherapy (control group; n = 30). Rehabilitation was performed five times a week for 3 weeks. The primary outcome was the cortical activation in the Morning Walk group. The secondary outcomes included gait speed, 10-Meter Walk Test (10MWT), FAC, Motricity Index-Lower (MI-Lower), Modified Barthel Index (MBI), Rivermead Mobility Index (RMI), and Berg Balance Scale (BBS). RESULTS: Thirty-six subjects were analyzed, 18 in the Morning Walk group and 18 in the control group. The cortical activation was lower in affected hemisphere than unaffected hemisphere at the beginning of robot rehabilitation. After training, the affected hemisphere achieved a higher increase in cortical activation than the unaffected hemisphere. Consequently, the cortical activation in affected hemisphere was significantly higher than that in unaffected hemisphere (P = 0.036). FAC, MBI, BBS, and RMI scores significantly improved in both groups. The Morning Walk group had significantly greater improvements than the control group in 10MWT (P = 0.017), gait speed (P = 0.043), BBS (P = 0.010), and MI-Lower (P = 0.047) scores. CONCLUSION: Robot-assisted gait training not only improved functional outcomes but also increased cortical activation in stroke patients.

Effects of robot (SUBAR)-assisted gait training in patients with chronic stroke: Randomized controlled trial.

BACKGROUND: SUBAR is a new ground walking exoskeletal robot. The objective of this study is to investigate SUBAR-assisted gait training's effects in patients with chronic stroke. METHODS: This preliminary study is a prospective randomized controlled trial. Thirty adults were enrolled 6 months after the onset of stroke with functional ambulation category scores ≥ 3. Patients were randomly assigned to receive robot-assisted gait training (SUBAR group, n = 15) or conventional physiotherapy (control group, n = 15). All patients received a total of 10 treatment sessions of 30 minutes each for 3 weeks. Before and after the 10-treatment sessions, patients were evaluated. The primary outcome is the 10 meter walk test and the secondary outcomes were the functional ambulation category scale, the Motricity Index-Lower, Modified Ashworth Scale (MAS), timed up and go, Rivermead Mobility Index, Berg Balance Scale (BBS), and gait analysis. RESULTS: In the SUBAR group, MAS and step length were significantly improved between pre- and posttreatment measurements (Δmean ±â€ŠSD: -1.1 ±â€Š1.6 and 5.5 ±â€Š7.6, P = .019 and .016, respectively). The SUBAR group improved the stride length and step length of the affected limb but not significantly. The control group had significant improvements in the BBS, MAS, and stride length between pre- and posttreatment measurements (Δmean ±â€ŠSD: 3.5 ±â€Š4.6, -0.8 ±â€Š1.5, and 6.5 ±â€Š9.5; P = .004, .031, and .035, respectively). The BBS improved more in the control group than in the SUBAR group. There were no other differences between the SUBAR group and the control group. CONCLUSION: Our results suggest that SUBAR-assisted gait training improved gait parameters in patients with chronic stroke. However, there was no significant difference in most outcome measures compared to conventional physiotherapy. Further research is warranted to measure the effects of SUBAR-assisted gait training.

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.

Morning Walk®-Assisted Gait Training Improves Walking Ability and Balance in Patients with Ataxia: a Randomized Controlled Trial.

This study aimed to investigate walking ability and balance improvement of patients with ataxia caused by brain lesions after end-effector type robot (Morning Walk®)-assisted gait training. This study randomly assigned 19 patients to one of two groups: 30 minutes of Morning Walk® training with 1 hour of conventional physiotherapy (Morning Walk® group; n = 10) or 1.5 hours of conventional physiotherapy (Control group; n = 9). Five treatment sessions per week were given for 3 weeks. The primary outcomes were walking ability and balance, which were assessed by the functional ambulation category (FAC) and Berg Balance Scale (BBS), respectively. The secondary outcomes included 10-meter Walk Test (10mWT), Rivermead Mobility Index (RMI), Motricity Index (MI), and Modified Barthel Index (MBI). At baseline, there was no statistically significant difference between the two groups except MBI. After the treatment, the Morning Walk® group showed significant improvement in the FAC, BBS, 10mWT, RMI and MBI. The control group showed significant improvement in the BBS, 10mWT, RMI and MBI. Inter-group comparison demonstrated that the ∆FAC, ∆10mWT and ∆RMI of the Morning Walk® group were significantly higher than those of the control group. Our results suggest that the patients with ataxia receiving Morning Walk®-assisted gait training might improve greater in walking ability and balance than those trained with conventional physiotherapy.

KSNR Clinical Consensus Statements: Rehabilitation of Patients with Parkinson's Disease.

Clinical consensus statements (CCSs) aim to improve care for patients with Parkinson's disease (PD) and reduce the variability of rehabilitation methods in clinical practice. A literature search was conducted to find available evidence on the rehabilitation of patients with PD and to determine the scope of CCSs. The selection of PD rehabilitation domains and key questions was done using the modified Delphi method in 43 expert panels. These panels achieved a consensus on 11 key questions regarding rehabilitation assessment and goal setting, gait and balance, activities of daily living, and swallowing and communication disorders. After the completion of an agreement procedure, 11 key consensus statements were developed by the consensus panel. These statements addressed the needs of rehabilitation as a continuum in patients with PD. They included the appropriate rehabilitation initiation time, assessment items, rehabilitation contents, and complication management. This agreement can be used by physiatrists, rehabilitation therapists, and other practitioners who take care of patients with PD. The consensus panel also highlighted areas where a consensus could not be reached. The development of more focused CCS or clinical practice guidelines that target specific rehabilitation approaches is considered the next needed step.

The Effect of Hypnotics on Sleep Quality and Cognitive Function in Patients with Brain Tumors.

OBJECTIVE: We investigated the effect of hypnotics on sleep quality, cognitive function, and depressive mood in patients with insomnia following brain tumor resection. METHODS: From patients who underwent brain tumor resection, we recruited 10 patients with insomnia who received hypnotics for more than 1 week during a 3-week follow-up period (insomnia group). We also recruited 12 control patients with brain tumors but without insomnia (control group). We evaluated sleep quality at baseline and 3 weeks later using the Insomnia Severity Index (ISI), the Pittsburgh Sleep Quality Index (PSQI), the Stanford Sleepiness Scale (SSS), and the Epworth Sleepiness Scale (ESS) and investigated cognitive function and depression using the Computerized Neuropsychological Test and the Beck Depression Inventory (BDI). RESULTS: At baseline, SSS, ISI, PSQI, and BDI scores were significantly higher and visual continuous performance test (VCPT) and auditory continuous performance test (ACPT) scores were significantly lower in the insomnia than in the control group. Three weeks later, the patients who had received hypnotics had significantly higher ISI, PSQI, ESS, VCPT, ACPT, visual span forward and backward, and visual recognition test scores, and significantly lower BDI scores. CONCLUSION: Quality of sleep in patients with insomnia following brain tumor resection was initially poor but improved significantly after taking hypnotic medication. Further, the hypnotic medications appeared to contribute to the amelioration of cognitive impairments and depressive moods in patients who previously underwent brain tumor resection. We thus recommend the use of hypnotics for patients with brain tumors with insomnia.

The effect of balance training with Tetra-ataxiometric posturography on balance function in patients with parkinsonism.

BACKGROUND: Balance impairment is a major clinical concern in patients with parkinsonism. Balance training with tetra-ataxiometric posturography (Tetrax) is known to improve balance function through visual biofeedback effects. OBJECTIVE: In this study, we evaluated the effects of balance training with Tetrax in patients with parkinsonism. METHODS: Patients with parkinsonism (idiopathic Parkinson's disease, multiple systemic atrophy, and multiple systemic atrophy) who were able to stand with or without an assistive device were recruited for the study. Twenty patients with parkinsonism were randomly assigned to one of the following two groups: (1) the Tetrax group, in which patients received Tetrax biofeedback balance training for 30 min/day for 2 weeks (10 sessions); and (2) the control group, in which patients received conventional balance training for 30 min/day for 2 weeks (10 sessions). One day before and after training, we measured patients' balance parameters using the Berg balance scale (BBS) and fall index (FI). RESULTS: The BBS and FI scores of the Tetrax group showed significant improvements after compared to before training. However, the scores in the control group were not significantly changed after vs. before conventional balance training. CONCLUSIONS: For patients with parkinsonism, Tetrax biofeedback balance training had a positive effect on balance function.