Estimating the minimal clinically important difference of upper extremity outcome measures in chronic stroke patients with moderate to severe impairment: a cross-sectional study.

BACKGROUND: Approximately 70% of chronic stroke patients experience upper extremity (UE) functional impairments, and UE outcome measures are often used as quality-of-life indicators. OBJECTIVE: The purpose of this study was to estimate minimal clinically important difference (MCID) values for UE outcome measures in chronic stroke patients with moderate to severe UE hemiplegia. METHODS: This study was a cross-sectional study, conducted as a secondary analysis of data from the ReoGo-J study, a multicenter, prospective, randomized, parallel-group trial of robot-assisted self-training for UE hemiplegia in chronic stroke. The patients were randomized to 1 of 3 treatment groups. Treatment was provided 3 times a week for 10 weeks, and UE outcome measures were evaluated before and after treatment. The anchor-based method was used to estimate MCID values for UE outcome measures, with Stroke Impact Scale (SIS) subscales as anchors. MCID values were estimated by identifying cutoff values in a receiver operating characteristic (ROC) curve. RESULTS: Between-group comparisons of UE outcome measures, based on the clinically important difference (CID) values of SIS subscales, revealed significant differences in both the Amount of Use (AOU) and Quality of Movement (QOM) components of the Motor Activity Log (MAL)-14. The estimated MCID values were 0.89 for the AOU component and 0.77 for the QOM component. CONCLUSIONS: The estimated MCID values for the MAL-14 not only add information regarding the clinical characteristics of the MAL-14 but also facilitate interpretations of changing scores in chronic stroke patients with moderate to severe UE hemiplegia undergoing rehabilitation therapy. STUDY REGISTRATION: https://www.umin.ac.jp/ctr/index.htm (UMIN000022509; 1 July 2016).

Rate of return to work in patients with stroke under the health and employment support program of Rosai hospitals in Japan.

To facilitate return to work (RTW) in patients with stroke, a health and employment support (HES) program was started at Rosai hospitals in Japan. This study aimed to determine the rate of RTW in patients with stroke under this support program. We collected demographic and clinical data of patients with stroke from the implementation reports of the HES program. The program provided coordinated dual support, such as acute medical treatments, and stroke and vocational rehabilitation on the medical side, and management and support on the workplace side. The primary endpoint was RTW. Successful and unsuccessful RTW were examined using the χ2 test. The RTW rate curves were analyzed using the Kaplan-Meier method. We enrolled 483 patients; 355 (73%) and 128 (27%) patients had successful and unsuccessful RTW, respectively. Stroke types, neurological findings, and activities of daily living were significant factors for RTW. The Kaplan-Meier method revealed that left hemiplegia, right hemiplegia, and neuropsychological deficits, except for combined disability (hemiplegia with neuropsychological deficits), had similar RTW curves with an RTW rate of > 70%.

Impaired neuronal integrity in traumatic brain injury detected by 123I-iomazenil single photon emission computed tomography and MRI.

This study was aiming at investigating the extent of neuronal damage in cases of traumatic brain injury (TBI) with diffuse axonal injury (DAI) using 123I-iomazenil(IMZ) SPECT and MRI. We compared the findings in 31 patients with TBI without any major focal brain lesions and 25 age-matched normal controls. Subjects underwent 123I-IMZ SPECT and MRI, and also assessment by cognitive function tests. The partial volume effect of 123I-IMZ SPECT was corrected using MRI. In the patients with TBI, decreased spatial concentration of 123I-IMZ binding was detected in the medial frontal/orbitofrontal cortex, posterior cingulate gyrus, cuneus, precuneus, and superior region of the cerebellum. ROC analysis of 123I-IMZ SPECT for the detection of neuronal injury showed a high diagnostic ability of 123I-IMZ binding density for TBI in these areas. The decreased 123I-IMZ uptake density in the cuneus and precuneus was associated with cognitive decline after the injury. In the patients with TBI, brain atrophy was detected in the frontal lobe, anterior temporal and parietal cortex, corpus callosum, and posterior part of the cerebellum. Evaluation of the neuronal integrity by 123I-IMZ SPECT and MRI provides important information for the diagnosis and pathological interpretation in cases of TBI with DAI.

Robot-Assisted Training as Self-Training for Upper-Limb Hemiplegia in Chronic Stroke: A Randomized Controlled Trial.

BACKGROUND: This study aimed to examine whether robotic self-training improved upper-extremity function versus conventional self-training in mild-to-moderate hemiplegic chronic stroke patients. METHODS: Study design was a multi-center, prospective, randomized, parallel-group study comparing three therapist-guided interventions (1-hour sessions, 3×/wk, 10 weeks). We identified 161 prospective patients with chronic, poststroke, upper-limb hemiplegia treated at participating rehabilitation centers. Patients were enrolled between November 29, 2016, and November 12, 2018 in Japan. A blinded web-based allocation system was used to randomly assign 129 qualifying patients into 3 groups: (1) conventional self-training plus conventional therapy (control, N=42); (2) robotic self-training (ReoGo-J) plus conventional therapy (robotic therapy [RT], N=44); or (3) robotic self-training plus constraint-induced movement therapy (N=43). PRIMARY OUTCOME: Fugl-Meyer Assessment for upper-extremity. SECONDARY OUTCOMES: Motor Activity Log-14 amount of use and quality of movement; Fugl-Meyer Assessment shoulder/elbow/forearm, wrist, finger, and coordination scores; Action Research Arm Test Score; Motricity Index; Modified Ashworth Scale; shoulder, elbow, forearm, wrist, and finger range of motion; and Stroke Impact Scale (the assessors were blinded). Safety outcomes were adverse events. RESULTS: Safety was assessed in 127 patients. An intention-to-treat full analysis set (N=121), and a per-protocol set (N=115) of patients who attended 80% of sessions were assessed. One severe adverse event was recorded, unrelated to the robotic device. No significant differences in Fugl-Meyer Assessment for upper-extremity scores were observed between groups (RT versus control: -1.04 [95% CI, -2.79 to 0.71], P=0.40; RT versus movement therapy: -0.33 [95% CI, -2.02 to 1.36], P=0.90). The RT in the per-protocol set improved significantly in the Fugl-Meyer Assessment for upper-extremity shoulder/elbow/forearm score (RT versus control: -1.46 [95% CI, -2.63 to -0.29]; P=0.037). CONCLUSIONS: Robotic self-training did not improve upper-limb function versus usual self-training, but may be effective combined with conventional therapy in some populations (per-protocol set). REGISTRATION: URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000022509.

Impact of the robotic-assistance level on upper extremity function in stroke patients receiving adjunct robotic rehabilitation: sub-analysis of a randomized clinical trial.

BACKGROUND: Robotic therapy has been demonstrated to be effective in treating upper extremity (UE) paresis in stroke survivors. However, it remains unclear whether the level of assistance provided by robotics in UE training could affect the improvement in UE function in stroke survivors. We aimed to exploratorily investigate the impact of robotic assistance level and modes of adjustment on functional improvement in a stroke-affected UE. METHODS: We analyzed the data of 30 subacute stroke survivors with mild-to-severe UE hemiplegia who were randomly assigned to the robotic therapy (using ReoGo System) group in our previous randomized clinical trial. A cluster analysis based on the training results (the percentage of each stroke patient's five assistance modes of robotics used during the training) was performed. The patients were divided into two groups: high and low robotic assistance groups. Additionally, the two groups were sub-categorized into the following classes based on the severity of UE functional impairment: moderate-to-mild [Fugl-Meyer Assessment (FMA) score ≥ 30] and severe-to-moderate class (FMA < 30). The outcomes were assessed using FMA, FMA-proximal, performance-time in the Wolf motor function test (WMFT), and functional assessment scale (FAS) in WMFT. The outcomes of each class in the two groups were analyzed. A two-way analysis of variance (ANOVA) was conducted with robot assistance level and severity of UE function as explanatory factors and the change in each outcome pre- and post-intervention as the objective factor. RESULTS: Overall, significant differences of the group × severity interaction were found in most of the outcomes, including FMA-proximal (p = 0.038, η2 = 0.13), WMFT-PT (p = 0.021, η2 = 0.17), and WMFT-FAS (p = 0.045, η2 = 0.14). However, only the FMA score appeared not to be significantly different in each group (p = 0.103, η2 = 0.09). CONCLUSION: An optimal amount of robotic assistance is a key to maximize improvement in post-stroke UE paralysis. Furthermore, severity of UE paralysis is an important consideration when deciding the amount of assistance in robotic therapy. Trial registration Trial enrollment was done at UMIN (UMIN 000001619, registration date was January 1, 2009).

Clinical effectiveness of peroneal nerve functional electrical stimulation in chronic stroke patients with hemiplegia (PLEASURE): A multicentre, prospective, randomised controlled trial.

OBJECTIVE: To compare the effectiveness of gait training using a peroneal nerve stimulation device with the effectiveness of gait training without the device in improving gait ability and ankle-specific body functions. DESIGN: Multicentre, prospective, randomised, open-label trial. SETTING: Twenty-three hospitals. SUBJECTS: In total, 119 stroke patients with foot drop were randomly assigned to the experimental (with the device) or control (without the device) group. INTERVENTION: Subjects underwent 480-minute self-directed training over four weeks, followed by 260-minute physical therapist-assisted gait training with or without the device. MAIN MEASURES: The primary endpoint was a change in the six-minute walk test (6MWT) without the device from baseline to after the four-week intervention. The secondary endpoints were changes in the 10-metre walk test (10MWT) without the device, Fugl-Meyer Assessment, range of motion, muscle strength, Modified Ashworth Scale, Stroke Impact Scale Japanese edition (J-SIS) and adverse events. RESULTS: Fifty-six experimental and 59 control group participants, with an average age of 59 years (SD 12) completed the trial. The 6MWT distance changes (m) for the experimental and control groups were 14.7 (SD 37.6) and 22.2 (SD 49.3), respectively. The 10MWT speed changes (m/sec) for the experimental and control groups were 0.06 (SD 0.12) and 0.07 (SD 0.17), respectively. No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient's subjective assessment (P = 0.048). CONCLUSION: The improvement in gait ability and body functions were equivalent with or without the use of the device.

Clinical outcomes of cerebral infarction in nonagenarians compared among four age groups.

BACKGROUND: Average female life expectancy in Japan is approximately 90 years. Occasionally, we encounter stroke patients older than 90 years. AIMS: To determine the clinical features and outcomes associated with cerebral infarction in patients aged ≥ 90 years. METHODS: We examined 289 consecutive patients (163 males, 129 females; mean age 77.5 years) diagnosed with cerebral infarction. We divided them into four groups according to age in years: middle (< 65), pre-old (65-74), old (75-89), and super old (≥ 90). We divided the super old group into mild symptoms (NIHSS ≤ 5) and severe symptoms (NIHSS > 5) and examined outcomes. RESULTS: Statistically significant associations were observed between female sex, cardiogenic infarction, and high complication rates and super old age. NIHSS and mRS scores at 30-day post-stroke were higher in the super old group. In some cases, complications led to poor prognoses. Eighty-seven percent of patients with mild symptoms (NIHSS ≤ 5) recovered to mRS 0-2 similar to the younger age group. None of the patients with severe symptoms (NIHSS > 5) recovered to mRS 0-2. DISCUSSION: We investigated the clinical outcomes following cerebral infarction in patients aged 90 years or older and found that mild symptoms were consistently associated with good prognoses, regardless of patients' age. CONCLUSIONS: Patients in the super old group had more severe symptoms and poorer outcomes than younger age groups. However, patients with mild symptoms tended to have better prognoses and returned to daily life similar to the younger age group.

Impact of initial flexor synergy pattern scores on improving upper extremity function in stroke patients treated with adjunct robotic rehabilitation: A randomized clinical trial.

Background: Robot-assisted rehabilitation is an appealing strategy for patients after stroke, as it generates repetitive movements in a consistent, precise, and automated manner. Objective: To identify patients who will benefit most from robotic rehabilitation for upper extremity (UE) hemiparesis. Methods:We used data from our previous randomized clinical trial comparing 6 weeks of robotic therapy (ReoGeo system) plus standard therapy (n=30) with self-guided therapy plus standard therapy (n=26) for sub-acute phase rehabilitation in adults with mild to moderate UE hemiparesis. The outcome measures were three Fugl-Meyer (FMA) motor scores: total UE score, proximal UE score, and UE flexor synergy score. Based on pre-therapy UE flexor synergy scores, participants were categorized into mild (10-12 points), moderate (6-9 points), and severe (0-5 points) impairment classes. Results: In the robotic group, all outcome measures improved after therapy in patients with moderate or severe impairment. In the self-guided therapy, most outcomes did not improve, regardless of the impairment class. When changes from pre- to post-therapy were compared between robotic and self-guided groups, most outcomes were similar in all impairment classes. However, robotic therapy was associated with greater improvement in UE flexor synergy than self-guided therapy in patients with moderate impairment (2.3±1.3 vs. -0.1±2.8, P=0.027). Conclusions: Post-strokerobot-assisted rehabilitation, as an adjunct to standard rehabilitation therapy, improved UE function in patients with moderate or severe pre-therapy UE flexor synergy impairment. Adjunct robotic therapy produced greater improvement in UE flexor synergy motor function than adjunct self-guided rehabilitation in patients with moderate pre-therapy impairment.

Assessment of the Efficacy of ReoGo-J Robotic Training Against Other Rehabilitation Therapies for Upper-Limb Hemiplegia After Stroke: Protocol for a Randomized Controlled Trial.

Background: Stroke patients experience chronic hemiparesis in their upper extremities leaving negative effects on quality of life. Robotic therapy is one method to recover arm function, but its research is still in its infancy. Research questions of this study is to investigate how to maximize the benefit of robotic therapy using ReoGo-J for arm hemiplegia in chronic stroke patients. Methods: Design of this study is a multi-center parallel group trial following the prospective, randomized, open-label, blinded endpoint (PROBE) study model. Participants and setting will be 120 chronic stroke patients (over 6 months post-stroke) will be randomly allocated to three different rehabilitation protocols. In this study, the control group will receive 20 min of standard rehabilitation (conventional occupational therapy) and 40 min of self-training (i.e., sanding, placing and stretching). The robotic therapy group will receive 20 min of standard rehabilitation and 40 min of robotic therapy using ReoGo®-J device. The combined therapy group will receive 40 min of robotic therapy and 20 min of constraint-induced movement therapy (protocol to improve upper-limb use in ADL suggests). This study employs the Fugl-Meyer Assessment upper-limb score (primary outcome), other arm function measures and the Stroke Impact Scale score will be measured at baseline, 5 and 10 weeks of the treatment phase. In analysis of this study, we use the mixed effects model for repeated measures to compare changes in outcomes between groups at 5 and 10 Weeks. The registration number of this study is UMIN000022509. Conclusions: This study is a feasible, multi-site randomized controlled trial to examine our hypothesis that combined training protocol could maximize the benefit of robotic therapy and best effective therapeutic strategy for patients with upper-limb hemiparesis.

Examination of Factors Related to the Effect of Improving Gait Speed With Functional Electrical Stimulation Intervention for Stroke Patients.

BACKGROUND: Functional electrical stimulation (FES) for patients with stroke and foot drop is an alternative to ankle foot orthoses. Characteristics of FES responders and nonresponders have not been clarified. OBJECTIVES: (1) To investigate the effects of treatment with FES on patients with stroke and foot drop and (2) to determine which factors may relate to responders and nonresponders. DESIGN: Multicenter, nonrandomized, prospective study. SETTING: Multicenter clinical trial. PARTICIPANTS: Participants included those who experienced foot drop resulting from stroke, were older than 20 years, and could provide consent to participate; they were enrolled from hospitals between January 2013 and September 2015 and performed rehabilitation with FES. METHODS: Stroke Impairment Assessment Set Foot-Pat Test (SIAS-FP), Fugl-Meyer Assessment for Lower Extremity (FMA-LE), Modified Ashworth scale (MAS) for ankle joint dorsiflexion and plantar flexion muscles, range of motion (ROM) for ankle joint, 10-m walking test (10mWT), Timed Up & Go test (TUG), and 6-minute walking test (6MWT) were evaluated pre- and postintervention. Age, gender, type of stroke, onset times of stroke, paretic side, Brunnstrom stage of the lower extremity (Br. stage-LE), Functional Independence Measure (FIM), Functional Ambulation Category (FAC), poststroke months, number of interventions, total hours of interventions, and whether a brace was used were extracted from patients' medical records and collected on the physiological examination day. MAIN OUTCOME MEASUREMENTS: The authors examined 10mWT and age, gender, type of stroke, onset times of stroke, paretic side, Br. stage-LE, FIM, FAC, poststroke months, number of interventions, total hours of interventions, whether a brace was used, SIAS-FP, FMA-LE, MAS, ROM, TUG, and 6MWT before intervention. Participants were divided into nonresponders and responders with a change in 10mWT of <0.1 and ≥0.1 m/s, respectively. Single and multiple regression analyses were used for data analysis. Additionally, the changes between groups were compared. RESULTS: Fifty-eight responders and 43 nonresponders were enrolled. The between-group differences, compared for changes between pre- and postintervention, were significant in terms of changes in SIAS-FP (P = .02), 10mWT (P < .001), 10-m gait steps (P < .001), TUG (P = .04), and 6MWT (P = .006). In the adjusted regression model, gender (odds ratio [OR], 3.92; 95% confidence interval [CI], 1.426-12.25; P = .007), number of interventions (OR, 1.028; 95% CI, 1.003-1.070; P = .03), and active ankle joint dorsiflexion ROM (OR, 1.047; 95% CI, 1.014-1.088; P = .005) remained significant. CONCLUSION: The factors related to 10mWT showing changes beyond the minimal clinically important difference were found to be patient gender, number of interventions, and active ankle joint dorsiflexion ROM before intervention. When patients with stroke who have greater active ankle joint ROM, and are female, use FES positively, they may benefit more from using FES. LEVEL OF EVIDENCE: II.

Development of a simple driving simulator and determination of the reference range of normative performance.

OBJECTIVE: To establish the reference range for assessment items of the 'Simple Driving Simulator' (SiDS) in a normative population and to compare performance of age-matched young adults with a traumatic brain injury (TBI) to this reference data. METHODS AND PROCEDURES: Normative ranges were calculated from the data of 445 participants in the control group. Three performance ranges were established: 'normal', 'borderline' and 'impaired' defined using standard deviation cutoff values in the control group. The performance of 28 patients with a TBI, aged 18-35 years, was evaluated. The performance score for the TBI group in the 'impaired range' was calculated for each test item and used to make a synthetic judgment regarding the clinical value of the SiDS. MAIN OUTCOMES AND RESULTS: In the control group, only 0.6% of the participants exhibited a performance in the impaired range on >2 items, compared to 33.2% for the TBI group. CONCLUSIONS: We provide evidence that impaired performance on ≤2 items of the SiDS provides a sensitive criterion of 'driving fitness' in young adults after a TBI.

Development and reliability of a hand-held dynamometer device to measure the ankle dorsiflexor muscle strength.

BACKGROUND: Ankle dorsiflexor muscle strength is a crucial component of gait. OBJECTIVE: We describe the development of a simple, hand-held dynamometer to measure the ankle dorsiflexor muscle strength in the sitting position. In addition, we examine its intra- and inter-rater reliability. METHODS: Measurements of the peak ankle dorsiflexor muscle strength were obtained by two examiners for 30 ankles of 15 healthy adults at two time points, with a one-day interval between measurements, to determine the inter- and intra-rater reliability. The intraclass correlation coefficients were calculated, and an intraclass correlation coefficient > 0.90 was considered as excellent reliability. A Bland-Altman analysis was used to assess systemic bias. The minimal detectable change in muscle strength was calculated with a confidence level of 95% (MDC95). RESULTS: The reliability of the device was excellent for both intra- (intraclass correlation coefficients [1,3] = 0.94) and inter-rater (intraclass correlation coefficients [2,3] = 0.96) comparisons. No fixed or proportional bias was observed between the two examiners. The MDC95 was 0.77 N/kg. CONCLUSIONS: Our results indicate the excellent reliability and responsiveness of our device. By obtaining the measurements of dorsiflexor strength while sitting, compensatory motions are suppressed, yielding a more consistent measurement that can be reliably used to detect subtle changes in the ankle dorsiflexor muscle strength.

The Reliability and Validity of the Japanese Version of the Stroke Impact Scale Version 3.0.

It is important to evaluate body functions and structures, activity, and participation in stroke rehabilitation. The Stroke Impact Scale (SIS), a new stroke-specific self-report measure that was developed by Duncan et al, is widely used to measure multidimensional consequences about health-related quality of life. The SIS version 3.0 includes 9 domains (strength, hand function, activity of daily living and instrumental activity of daily living, mobility, communication, emotion, memory and thinking, participation, and recovery). Patients are asked to make a percentage rating of their recovery since their stroke on a visual analog scale of 0 to 100 for the stroke recovery domain. Each item in the 8 domains other than stroke recovery are scored in a range of 1 to 5 as a raw score and calculated using the manual to a final score. We developed a Japanese version of the SIS version 3.0 and assessed its reliability and validity in 32 chronic stroke survivors. The internal consistency (Cronbach's α < 0.70) was satisfactory. The test-retest reliability (ICC, 0.86 to 0.96) was also satisfactory. Regarding convergent validity, a significant correlation (Spearman's correlation coefficient, P < 0.05) was found between the SIS physical domain score and Brunnstrom stage (r, 0.49 to 0.53) and short form 8 (r = 0.82). The Japanese version of the SIS version 3.0 is valid, reliable, and clinically useful for stroke survivors.

[Rehabilitation and nursing-care robots].

In the extremely aged society, rehabilitation staff will be required to provide ample rehabilitation training for more stroke patients and more aged people with disabilities despite limitations in human resources. A nursing-care robot is one potential solution from the standpoint of rehabilitation. The nursing-care robot is defined as a robot which assists aged people and persons with disabilities in daily life and social life activities. The nursing-care robot consists of an independent support robot, caregiver support robot, and life support robot. Although many nursing-care robots have been developed, the most appropriate robot must be selected according to its features and the needs of patients and caregivers in the field of nursing-care.

A Case of Apoplexy Attack-Like Neuropathy due to Hereditary Neuropathy with Liability to Pressure Palsies in a Patient Diagnosed with Chronic Cerebral Infarction.

Hereditary neuropathy with liability to pressure palsies is an inherited disease associated with the loss of a copy of the PMP22 gene. The condition leads to mononeuropathy due to compression and easy strangulation during daily life activities, resulting in sudden muscle weakness and sensory disturbance, and displaying symptoms similar to cerebrovascular diseases. We report the case of an 80-year-old man with left paralysis due to chronic cerebral infarction. His medical history indicated remarkable recovery from about 4 months after the onset of left hemiplegia with predominant involvement of the fingers. Despite subsequent recurrent monoplegia of the upper or lower limbs, brain magnetic resonance imaging consistently revealed only previous cerebral infarction in the right corona radiata without new lesions. Medical examination showed reduced deep tendon reflexes in his extremities on both the healthy and hemiplegic sides. Nerve conduction studies showed delayed conduction at the bilateral carpal and cubital tunnels and near the right caput fibulae. Genetic analysis revealed loss of a copy of the PMP22 gene. Thus, he was diagnosed with a cerebral infarction complicated by hereditary neuropathy with liability to pressure palsies. Stroke patients develop sudden muscle weakness and sensory disturbance. However, if such patients have no hyperactive deep tendon reflexes and show atypical recovery of paralysis that does not correspond to findings of imaging modalities, nerve conduction studies and genetic analysis may be necessary, considering the complication of hereditary neuropathy with liability to pressure palsies.

Efficacy of Upper Extremity Robotic Therapy in Subacute Poststroke Hemiplegia: An Exploratory Randomized Trial.

BACKGROUND AND PURPOSE: Our aim was to study the efficacy of robotic therapy as an adjuvant to standard therapy during poststroke rehabilitation. METHODS: Prospective, open, blinded end point, randomized, multicenter exploratory clinical trial in Japan of 60 individuals with mild to moderate hemiplegia 4 to 8 weeks post stroke randomized to receive standard therapy plus 40 minutes of either robotic or self-guided therapy for 6 weeks (7 days/week). Upper extremity impairment before and after intervention was measured using the Fugl-Meyer assessment, Wolf Motor Function Test, and Motor Activity Log. RESULTS: Robotic therapy significantly improved Fugl-Meyer assessment flexor synergy (2.1±2.7 versus -0.1±2.4; P<0.01) and proximal upper extremity (4.8±5.0 versus 1.9±5.5; P<0.05) compared with self-guided therapy. No significant changes in Wolf Motor Function Test or Motor Activity Log were observed. Robotic therapy also significantly improved Fugl-Meyer assessment proximal upper extremity among low-functioning patients (baseline Fugl-Meyer assessment score <30) and among patients with Wolf Motor Function Test ≥120 at baseline compared with self-guided therapy (P<0.05 for both). CONCLUSIONS: Robotic therapy as an adjuvant to standard rehabilitation may improve upper extremity recovery in moderately impaired poststroke patients. Results of this exploratory study should be interpreted with caution. CLINICAL TRIAL REGISTRATION: URL: http://www.umin.ac.jp/. Unique identifier: UMIN000001619.

Development of wrist rehabilitation robot and interface system.

The authors have developed a practical wrist rehabilitation robot for hemiplegic patients. It consists of a mechanical rotation unit, sensor, grip, and computer system. A myoelectric sensor is used to monitor the extensor carpi radialis longus/brevis muscle and flexor carpi radialis muscle activity during training. The training robot can provoke training through myoelectric sensors, a biological signal detector and processor in advance, so that patients can undergo effective training of extention and flexion in an excited condition. In addition, both-wrist system has been developed for mirror effect training, which is the most effective function of the system, so that autonomous training using both wrists is possible. Furthermore, a user-friendly screen interface with easily recognizable touch panels has been developed to give effective training for patients. The developed robot is small size and easy to carry. The developed aspiring interface system is effective to motivate the training of patients. The effectiveness of the robot system has been verified in hospital trails.

Effects of low-dose milnacipran on event-related potentials and neuropsychological tests in persons with traumatic brain injury: A preliminary study.

INTRODUCTION: Psychostimulants are among the most commonly used pharmacological agents for countering cognitive dysfunction and/or enhancing rehabilitation in persons with brain injury. It was postulated that milnacipran, a serotonin-norepinephrine reuptake inhibitor, would be effective against cognitive dysfunction in non-depressed persons with brain injury. METHODS: Eighteen patients were recruited with at least moderate disability more than 4 months after a traumatic brain injury (TBI) and they were randomized to an 8-week, placebo-controlled, double-blind trial. Cognitive dysfunction was assessed at baseline with the Trail Making Test, the Wechsler Adult Intelligence Scale-Revised (WAIS-R), the Wechsler Memory Scale-Revised (WMS-R) and measurement of event-related potentials (ERPs) both before randomization and after an 8-week administration of milnacipran or placebo. RESULTS: N2 and P3 latencies in the milnacipran group were significantly shortened by the intervention. Moreover, the Verbal Intelligence Quotient and Full Intelligence Quotient scores of the WAIS-R and the delayed recall score of the WMS-R were significantly higher than baseline after milnacipran intervention. CONCLUSION: Milnacipran administration improved ERP measures of attention and information processing in non-depressed persons with brain injury and also improved scores on three sub-scales of standard neuropsychological tests of cognitive dysfunction. Therefore, this intervention merits validation by additional, larger studies.

Gait training in subacute non-ambulatory stroke patients using a full weight-bearing gait-assistance robot: A prospective, randomized, open, blinded-endpoint trial.

BACKGROUND: This study was a prospective, randomized, open, blinded-endpoint trial with the aim of examining whether gait training with a gait-assistance robot (GAR) improves gait disturbances in subacute non-ambulatory hemiplegic stroke patients more than overground conventional gait training. The GAR adopts a robot arm control system with full weight bearing and foot pressure visual biofeedback. METHODS: Twenty-six hemiplegic patients were randomly assigned to either the GAR-assisted gait training (GAGT) group or the overground conventional gait training (OCGT) group. Both groups underwent 60 min of standard physical therapy and 20 min of GAGT or OCGT 5 days a week for 4 weeks. The primary outcome measure was the Functional Ambulation Classification (FAC). The secondary outcome measures were the peak torque of the extensor muscles in the lower extremities and a 10-m walking test. The lower extremity function was evaluated using the Fugl-Meyer Assessment, and activities of daily living were assessed using the Functional Independence Measure. RESULTS: The GAGT group demonstrated significantly greater improvements in FAC and peak torque on the unaffected side (p=0.02) than the OCGT group. Additionally, gait speed tended to be faster (p=0.07) in the GAGT group. CONCLUSIONS: GAGT combined with standard physical therapy in subacute non-ambulatory hemiplegic patients led to significant improvements in gait and peak torque on the unaffected side compared to OCGT.

Peripheral Neuropathies in Nonparetic Upper Extremities of Stroke Patients Induced by Excessive Use of a Walking Device.

BACKGROUND: Poststroke patients reportedly experience entrapment neuropathies in the nonparetic upper extremities, and the use of an assistive device for long periods may increase this risk. We examined nerve conduction velocities in hemiparetic patients and investigated the relationship between abnormal measurements and duration of walking. METHODS: Twenty-eight male hemiparetic outpatients who used a cane or a crutch participated in this study. Clinical characteristics such as age, period of time from stroke onset, side and severity of paresis, activities of daily living, and basic ability to walk, as well as each patient's approximate number of hours walking per day, were collected. Electrophysiological evaluation was performed via nerve conduction studies of the median, ulnar, and radial nerves. The clinical features were compared between patients with and without peripheral neuropathies. RESULTS: Twelve patients (43%) had peripheral neuropathies involving a total of 15 nerves. There was no difference in age, duration of hemiparesis, side and severity of paresis, Barthel index, and Functional Ambulation Classification between the 2 groups. Abnormalities were absent in the patients who walked at or less than an hour but were present in 50% and 63.4% of patients with walking times of 1-2 hours and more than 2 hours, respectively. CONCLUSIONS: Excessive use of a T-cane or a Lofstrand crutch was hypothesized to induce entrapment neuropathies in the nonparetic upper extremity. To prevent these injuries, a well-balanced gait should be established to reduce the load on the walking device.