Effects of cardiac rehabilitation with motion assistance from a wearable cyborg hybrid assistive limb on patients with chronic heart failure: a randomized controlled trial with a one-year follow-up.

[Purpose] We have recently reported that using a wearable cyborg hybrid assistive limb improved the isometric knee extensor muscle strength of patients with chronic heart failure. Here, we investigated the long-term effects of a lumbar-type hybrid assistive limb for patients with chronic heart failure. [Participants and Methods] A total of 28 hospitalized patients with chronic heart failure (mean age, 73.1 ± 13.8 years) were randomly assigned to two groups: the hybrid assistive limb group or the control group, in which they performed a sit-to-stand exercise with or without the hybrid assistive limb, respectively. The cardiac rehabilitation therapy included this intervention, which was performed as many times as possible for 5-30 minutes per day for 6-10 days. Clinical assessments like lower-limb muscle strength, walking ability, etc., were measured before and after the intervention. Cardiac events were followed up for up to a year after discharge. [Results] No adverse events occurred during the study period in either group. In terms of long-term effects, the incidence of cardiac events was 23% and 45% in the hybrid assistive limb and the control groups, respectively. [Conclusion] Hybrid assistive limb-assisted exercise therapy may be a safe and feasible cardiac rehabilitation tool in patients with chronic heart failure. The lumbar-type wearable cyborg hybrid assistive limb may have a positive effect on heart failure prognosis by adding long-term exercise therapy.

Effects of Cardiac Rehabilitation With Lumbar-Type Hybrid Assistive Limb on Muscle Strength in Patients With Chronic Heart Failure　- A Randomized Controlled Trial.

BACKGROUND: Aiming to establish an effective tool in new cardiac rehabilitation programs, we investigated the use of a lumbar-type hybrid assistive limb (HAL) in patients with heart failure (HF) who had difficulty in walking at the usual speed of healthy subjects (≈80 m/min).Methods and Results:We randomly assigned 28 HF patients (age, 73.1±13.8 years) to perform a sit-to-stand exercise with or without HAL. The sit-to-stand exercise was repeated as many times as possible as cardiac rehabilitation therapy over a period of 6-10 days. We measured 5 parameters before and after the completion of cardiac rehabilitation: B-type natriuretic peptide, Short Physical Performance Battery (SPPB), 6-min walking distance (6MWD), 30-s chair-stand test (CS-30), and isometric knee extensor muscle strength. The SPPB and 6MWD were significantly improved, and the CS-30 score was somewhat improved, after the exercise therapy in both the HAL and non-HAL groups. The knee extensor muscle strength improved significantly in the HAL group (0.29±0.11 to 0.35±0.11 kgf/kg, P<0.01), but showed no change in the non-HAL group (0.35±0.11 to 0.35±0.13 kgf/kg, P=0.40). CONCLUSIONS: The improved knee extensor muscle strength in the HAL group suggests that the lumbar-type HAL may be an effective tool for cardiac rehabilitation in HF patients with frailty, which is a predictor of poor prognosis in HF.

Exercise training using hybrid assistive limb (HAL) lumbar type for locomotive syndrome: a pilot study.

BACKGROUND: With a rapidly aging population in Japan, locomotive syndrome is becoming an increasingly serious social problem. Exercise therapy using the lumbar type HAL, which is a wearable robot suit that can assist voluntary hip joint motion, would be expected to cause some beneficial effects for people with locomotive syndrome. The purpose of this study was to assess whether the deterioration of low back pain and any other adverse events would occur following HAL exercise therapy. Moreover, the changes of motor ability variables were evaluated. METHODS: We enrolled 33 participants (16 men, 17 women) with locomotive syndrome in this study. They received exercise training (sit-to-stand, lumbar flexion-extension, and gait training) with HAL (in total 12 sessions). We assessed the change of low back pain (lumbar VAS). More than 50% and 25 mm increase compared to baseline was defined as adverse events. One-leg standing time (OLST), 10-m walking test (10MWT), Timed Up and Go test (TUG), 1-min sit-to-stand test (1MSTS), FIM mobility scores and EQ-5D were measured. RESULTS: Of the 33 participants, 32 (16 men, 16 women) (97.0%) completed all 12 exercise training sessions using the lumbar type HAL. One woman aged 82 years withdrew because of right upper limb pain after the second session regardless of the use of HAL. There was no participant who had deterioration of low back pain. Any other adverse events including external injuries and/or falling, skin disorders, uncontrollable cardiovascular or respiratory disorders, and other health disorders directly related to this exercise therapy did not occur. Several outcome measures of motion ability including OLST, TUG and 1MSTS, EQ VAS and lumbar pain improved significantly after this HAL training. CONCLUSIONS: Almost all patients with locomotive syndrome completed this exercise training protocol without any adverse events related to HAL. Furthermore, balance function variables including OLST, TUG and 1MSTS improved after this HAL exercise therapy even though mobility function variables including 10MWT and FIM mobility scores did not show any significant change. These findings suggest that the exercise therapy using the lumbar type HAL would be one of the options for the intervention in locomotive syndrome.

Efficacy of Cardiac Rehabilitation with Assistance from Hybrid Assistive Limb in Patients with Chronic Heart Failure: Protocol for a Randomized Controlled Study.

The hybrid assistive limb (HAL) provides motion assistance based on bioelectrical signals detected on the skin surface when muscle forces are generated. The lumbar-type HAL is expected to expand the therapeutic options for severe cardiac patients who have difficulty in moving on their own legs. We aim to compare the efficacy of exercise therapy performed with assistance from a lumbar-type HAL versus conventional training (sit-to-stand exercise without HAL) in patients with chronic heart failure. This investigation will be a randomized, nonblinded, controlled study. Sixty patients who satisfy the criteria to receive cardiac rehabilitation therapy under the Japanese national insurance system will be enrolled at the University of Tsukuba Hospital. Participants randomly assigned to 2 groups (HAL group and conventional group) at a 1:1 allocation ratio will perform exercise therapy either with HAL or without HAL for 5-30 min once a day for 6-10 days. Outcome parameters will be measured just before and after the completion of the exercise therapy and at 1 year after hospital discharge. The primary outcomes will be the heart rate, blood pressure, subjective ratings of exercise intensity during exercise (Borg scale), number of days from the start of exercise therapy to independent walking and to discharge, and prognosis (mortality and cardiovascular events) over the 1-year period after discharge. The secondary outcomes will be the assessment of heart failure severity, brain natriuretic peptide, grip strength, thigh muscle thickness, isometric knee extensor strength, standing ability, 10-meter walking speed, 6-min walking distance, short physical performance battery, and adverse events. Unpaired t tests will be used for baseline assessments and outcome measures. This is the first randomized controlled study to examine the efficacy and feasibility of lumbar-type HAL in patients with chronic heart failure. If the results confirm beneficial effects in the outcomes of patients with heart failure, this study will add more evidence in support of the use of the lumbar-type HAL as an effective tool in new cardiac rehabilitation programs.

Effects of a cyborg-type robot suit HAL on cardiopulmonary burden during exercise in normal subjects.

BACKGROUND: The hybrid assistive limb (HAL) is the world's first cyborg-type robot suit that provides motion assistance to physically challenged patients. HAL is expected to expand the possibilities of exercise therapy for severe cardiac patients who have difficulty in moving on their own legs. As a first step, we examined whether or not the motion assistance provided by HAL during exercise could effectively reduce the cardiopulmonary burden in healthy subjects. METHODS: A total of ten healthy male adults (35 ± 12 years) underwent cardiopulmonary exercise testing (CPX) on a cycle ergometer with or without assistance from HAL. The CPX protocol consisted of four 3-min stages performed in a continuous sequence: rest, 0 W, 40 W, and 80 W. The heart rate (HR), blood pressure, oxygen uptake (VO2), minute ventilation (VE), and gas exchange ratio (R) were monitored during the CPX. RESULTS: At 0 W, the HR, VO2, and VE were significantly higher when HAL was used. At 80 W, however, the HR (107 ± 14 vs 114 ± 14 beats/min, p < 0.01), systolic blood pressure (141 ± 15 vs 155 ± 20 mmHg, p < 0.01), VO2 (17.6 ± 2.4 vs 19.0 ± 2.5 mL/min/kg, p < 0.05), and R (0.88 ± 0.04 vs 0.95 ± 0.09, p < 0.05) were significantly lower when HAL was used. CONCLUSIONS: HAL has the potential to reduce cardiopulmonary burden during moderate-intensity exercise and can, therefore, be used as a support for exercise therapy. Further studies on cardiac patients are expected to contribute to the establishment of a new exercise therapy program using HAL.

[Traumatic Intercostal Lung Hernia Repaired by Video-assisted Thoracoscopic Surgery;Report of a Case].

The 40-year-old male patient was raced to our hospital complaining respiratory difficulty after hitting his left chest at a handle when falling down from a bicycle. Fracture of 5th left rib and partial lung prolapsed intercostally out of the thorax was observed by computed tomography (CT). Due to exacerbated pneumothorax and pneumoderma recognized 12 hours later by CT with the lung remained incarcerated, a surgery was conducted. Camera port was placed from 8th intercostal part at left midaxillary line. The left lung was partially incarcerated from ruptured intercostal part of fractured 5th rib. Adding a working port from 7th intercostal part at the posterior axillary line, the incarcerated lung was thoracoscopically reduced. The thoracoscopic surgery was completed by fixing the rib outside the thoracic wall with 2-0 nylon suture without partial resection of the lung. The patient was discharged on day 7 with satisfactory progress. Thoracoscopic approach is effective for traumatic intercostal lung hernia.

[A Case of Cecum Cancer with Synchronous Adrenal Solitary Metastasis].

We herein report a case of cecum cancer with synchronous adrenal solitary metastasis. A 62-year-old woman who had been treated for other disease complained of weight loss. Lower endoscopy revealed cecum cancer, and computed tomography( CT)demonstrated a solitary left adrenal tumor; thus, she was diagnosed with a metastatic tumor. We concluded that the patient was a possible candidate for surgical resection because she did not present with local metastasis other than in the adrenal glands. Ileocecal resection and left adrenalectomy were performed. The histological findings indicated moderately differentiated adenocarcinoma, which was compatible with cecum cancer. The patient was administered chemotherapy containing mFOLFOX6, and no recurrence has been detected 4 years after the surgery. Some patients who develop solitary adrenal metastasis from colonic cancer appear to be good candidates for surgery in anticipation of a good prognosis.

A rare case of inflammatory myofibroblastic tumor of the diaphragmatic parietal pleura with dissemination.

Inflammatory myofibroblastic tumor (IMT) is a rare neoplasm that occurs at different sites in the body. Pleural IMT in particular is especially rare. IMTs infrequently tend to have malignancy. We report a rare case of advanced diaphragmatic parietal pleural IMT with dissemination. A 30-year-old woman complained of right upper abdominal pain. Computed tomography showed a large lobulated mass over the right diaphragm, but no disseminated nodules were noted. Intraoperatively, we found the primary tumor arising from the diaphragmatic parietal pleura and a dozen disseminated nodules, and we removed them completely. The histopathological and immunohistochemical diagnosis was IMT.

Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility.

BACKGROUND: Intensive task specific training early after stroke may enhance beneficial neuroplasticity and functional recovery. Impaired gait after hemiparetic stroke remains a challenge that may be approached early after stroke by use of novel technology. The aim of the study was to investigate the safety and feasibility of the exoskeleton Hybrid Assistive Limb (HAL) for intensive gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely impaired gait early after stroke. METHODS: Eligible were patients until 7 weeks after hemiparetic stroke. Training with HAL was performed 5 days per week by the autonomous and/or the voluntary control mode offered by the system. The study protocol covered safety and feasibility issues and aspects on motor function, gait performance according to the 10 Meter Walking Test (10MWT) and Functional Ambulation Categories (FAC), and activity performance. RESULTS: Eight patients completed the study. Median time from stroke to inclusion was 35 days (range 6 to 46). Training started by use of the autonomous HAL mode in all and later switched to the voluntary mode in all but one and required one or two physiotherapists. Number of training sessions ranged from 6 to 31 (median 17) and walking time per session was around 25 minutes. The training was well tolerated and no serious adverse events occurred. All patients improved their walking ability during the training period, as reflected by the 10MWT (from 111.5 to 40 seconds in median) and the FAC (from 0 to 1.5 score in median). CONCLUSIONS: The HAL system enables intensive training of gait in hemiparetic patients with severely impaired gait function early after stroke. The system is safe when used as part of an inpatient rehabilitation program for these patients by experienced physiotherapists.

[Pulmonary non-tuberculous mycobacteriosis complicated with lung cancer].

A 54-year-old man with pulmonary non-tuberculous mycobacteriosis( pulmonary NTM) who had been treated by antituberculous chemotherapy, developed a new nodule of 1.3 cm in size in the segment 1/2 of the right upper lobe. The cavity of 3.5 cm in size in the segment 6 of the right lower lobe from which Mycobacterium intracellulare was bronchoscopically detected, was suspected to be pulmonary NTM lesion. Since lung cancer was highly suspected by radiological examinations, right upper lobectomy and S6 segmentectomy were performed. Pathological diagnosis for the right upper lobe nodule was adenocarcinoma.

Pilot study of locomotion improvement using hybrid assistive limb in chronic stroke patients.

BACKGROUND: Locomotor training using robots is increasingly being used for rehabilitation to reduce manpower and the heavy burden on therapists, and the effectiveness of such techniques has been investigated. The robot suit Hybrid Assistive Limb (HAL) has been developed to rehabilitate or support motor function in people with disabilities. The HAL provides motion support that is tailored to the wearer's voluntary drive. We performed a pilot clinical trial to investigate the feasibility of locomotor training using the HAL in chronic stroke patients, and to examine differences between two functional ambulation subgroups. METHODS: Sixteen stroke patients in the chronic stage participated in this study. All patients were trained with the HAL over 16 sessions (20-30 min/day within 2 days/week). Primary outcomes were walking speed, cadence, and number of steps recorded during a 10-meter walk test (10MWT). Berg balance scale (BBS) and timed up and go (TUG) were also measured. All outcome measures were evaluated without wearing HAL assistance before and after the intervention in all patients as well as in the dependent ambulatory and independent ambulatory subgroups. RESULTS: All participants completed the intervention with no adverse events. Gait speed, cadence, number of steps during the 10MWT, and BBS increased significantly from 0.41 m/s to 0.45 m/s (P = 0.031), from 68.6 steps/min to 72.0 steps/min (P = 0.020), from 37.5 steps to 33.1 steps (P = 0.017), and from 40.6 to 45.4 (P = 0.004) respectively. The TUG test score improved, although this difference was not statistically significant. The findings in the dependent ambulatory subgroup primarily contributed to the significant differences observed in the group as a whole. CONCLUSIONS: This pilot study showed that locomotor training using the HAL is feasible for chronic stroke patients. Randomized controlled trials are now required to demonstrate the effectiveness of HAL-based rehabilitation over conventional therapies. TRIAL REGISTRATION: UMIN000002969.

Feasibility of rehabilitation training with a newly developed wearable robot for patients with limited mobility.

OBJECTIVE: To investigate the feasibility of rehabilitation training with a new wearable robot. DESIGN: Before-after clinical intervention. SETTING: University hospital and private rehabilitation facilities. PARTICIPANTS: A convenience sample of patients (N=38) with limited mobility. The underlying diseases were stroke (n=12), spinal cord injuries (n=8), musculoskeletal diseases (n=4), and other diseases (n=14). INTERVENTIONS: The patients received 90-minute training with a wearable robot twice per week for 8 weeks (16 sessions). MAIN OUTCOME MEASURES: Functional ambulation was assessed with the 10-m walk test (10MWT) and the Timed Up & Go (TUG) test, and balance ability was assessed with the Berg Balance Scale (BBS). Both assessments were performed at baseline and after rehabilitation. RESULTS: Thirty-two patients completed 16 sessions of training with the wearable robot. The results of the 10MWT included significant improvements in gait speed, number of steps, and cadence. Although improvements were observed, as measured with the TUG test and BBS, the results were not statistically significant. No serious adverse events were observed during the training. CONCLUSIONS: Eight weeks of rehabilitative training with the wearable robot (16 sessions of 90min) could be performed safely and effectively, even many years after the subjects received their diagnosis.

Safety and Feasibility Study of the Medical Care Pit Walking Support System for Rehabilitation of Acute Stroke Patients.

Stroke rehabilitation with mechanical assistance improves outcomes by facilitating repetition and relieving the care burden of therapy staff. Here, we tested the Medical Care Pit (MCP) walking assistance training device in the rehabilitation of eight acute stroke patients (median age 60.7 ± 16.3 years) who had recently suffered ischemic (three) or hemorrhagic (five) stroke (14.1 ± 6.5 days). Patients received standard rehabilitation approximately 5 days per week (weekdays only), plus MCP therapy twice a week, totaling four MCP sessions over 2 weeks. Fugl-Meyer Assessment-Lower Extremities (FMA-LE), Functional Ambulation Category (FAC), and other gait-associated parameters were measured. Over the 10.5 ± 1.6 days of therapy, MCP qualitatively assisted in gait analysis and real-time patient feedback while independent walking scores significantly improved (FAC 2.2 ± 0.8 to 3.1 ± 1.3, p = 0.020). FMA-LE scores also slightly improved but not to significance (p = 0.106). Objective burden on patients, as measured by modified Borg scale, was significantly improved (2.7 ± 1.6 to 2.0 ± 1.6, p = 0.014). In terms of questionnaires, anxiety scores for the physical therapist regarding gait training and falling with MCP significantly decreased (3.8 ± 2.3 to 1.0 ± 1.6; p = 0.027 and 3.1 ± 2.2 to 0.8 ± 1.3; p = 0.045) from the first to fourth sessions. Taken together, MCP, in addition to the usual rehabilitation program, was effective in gait rehabilitation for independent walking and relieved burdens on the patients. Such walking support systems may be an important part of acute stroke rehabilitation.

Gait improvement with wearable cyborg HAL trunk unit for parkinsonian patients: five case reports.

Cybernic treatment involves the generation of an interactive bio-feedback loop between an individual's nervous system and the worn cyborg Hybrid Assistive Limb (HAL); this treatment has been applied for several intractable neuromuscular disorders. Thus, it is of interest to determine its potential for parkinsonian patients. This study confirmed the feasibility of using a HAL trunk unit to improve parkinsonian gait disturbance. HAL establishes functional and physical synchronization with the wearer by providing lateral cyclic forces to the chest in the form of somatosensory and motor cues. To confirm the feasibility of its use for improving parkinsonian gait disturbances, we conducted experiments with three Parkinson's disease patients and two patients with progressive supranuclear palsy. During the experiments, the immediate effect of the intervention was assessed; all participants exhibited improvements in gait disturbance while wearing the HAL unit, and this improvement effect persisted without the HAL unit in two participants. Afterward, based on the assessment, we conducted a continuous intervention for one participant. In this intervention, the number of steps in the final experiment was significantly decreased compared with the initial state. These findings suggest that the proposed method is an option for treating parkinsonian patients to generate somatosensory and motor cues.

Feasibility and safety study of wearable cyborg Hybrid Assistive Limb for pediatric patients with cerebral palsy and spinal cord disorders.

Introduction: The wearable cyborg Hybrid Assistive Limb (HAL) is the world's first cyborg-type wearable robotic device, and it assists the user's voluntary movements and facilitates muscle activities. However, since the minimum height required for using the HAL is 150 cm, a smaller HAL (2S size) has been newly developed for pediatric use. This study aimed to (1) examine the feasibility and safety of a protocol for treatments with HAL (2S size) in pediatric patients and (2) explore the optimal method for assessing the efficacy of HAL. Methods: This clinical study included seven pediatric patients with postural and motor function disorders, who received 8-12 sessions of smaller HAL (2S size) treatment. The primary outcome was the Gross Motor Function Measure-88 (GMFM-88). The secondary outcomes were GMFM-66, 10-m walk test, 2- and 6-min walking distances, Canadian Occupational Performance Measure (COPM), a post-treatment questionnaire, adverse events, and device failures. Statistical analyses were performed using the paired samples t-test or Wilcoxon signed-rank test. Results: All participants completed the study protocol with no serious adverse events. GMFM-88 improved from 65.51 ± 21.97 to 66.72 ± 22.28 (p = 0.07). The improvements in the secondary outcomes were as follows: GMFM-66, 53.63 ± 11.94 to 54.96 ± 12.31, p = 0.04; step length, 0.32 ± 0.16 to 0.34 ± 0.16, p = 0.25; 2-MWD, 59.1 ± 57.0 to 62.8 ± 63.3, p = 0.54; COPM performance score, 3.7 ± 2.0 to 5.3 ± 1.9, p = 0.06; COPM satisfaction score, 3.3 ± 2.1 to 5.1 ± 2.1, p = 0.04. Discussion: In this exploratory study, we applied a new size of wearable cyborg HAL (2S size), to children with central nervous system disorders. We evaluated its safety, feasibility, and identified an optimal assessment method for multiple treatments. All participants completed the protocol with no serious adverse events. This study suggested that the GMFM would be an optimal assessment tool for validation trials of HAL (2S size) treatment in pediatric patients with posture and motor function disorders.

Staged treatment protocol for gait with hybrid assistive limb in the acute phase of patients with stroke.

Hybrid Assistive Limb (HAL) is a wearable human assistant cyborg-type robot that helps lower-leg movement based on bioelectrical signals detected from the voluntary movement of the person wearing it. In this study, we developed a novel staged HAL treatment protocol for patients with acute stroke. The Regain Program for Gait with HAL (RPG-HAL) was formulated in four steps, based on the severity of limb paralysis. Twenty-one patients with acute stroke received a combination treatment of RPG-HAL and conventional rehabilitation. The feasibility and safety of RPG-HAL were evaluated based on changes in physical function and activities of daily living (ADL). RPG-HAL yielded improvement in gait speed, cadence, step length, and functional ambulation category (FAC). The effect size was >0.8 in all measurements. FAC (1.90) and Barthel Index (BI) (1.92) exhibited the highest scores. Twelve out of 14 patients with FAC 0 before RPG-HAL reached the upper FAC. Thus, earlier intervention using RPG-HAL as improving physical function, ADL, and gait ability in patients with stroke.

Basic study of epileptic seizure detection using a single-channel frontal EEG and a pre-trained ResNet.

Epilepsy is a neurological disorder that causes sudden seizures due to abnormal excitation of neurons in the brain. Approximately 30 % of patients cannot control their seizures using medication. In addition, since seizures can occur anywhere and at any time, caregivers must always be with the patient. Various researchers have developed seizure detection methods using multichannel EEG to improve the quality of life of patients and caregivers. However, the large size of the measurement device impedes transportation. We believe that a portable measurement device with a small number of channels is suitable for detecting seizures in daily life. Therefore, we need a system that can detect seizures using a small number of channels. The purpose of this research is to develop a seizure detection algorithm using a single-channel frontal EEG and to confirm its basic performance. We used EEG signals from a single electrode position (Fp1-F7, Fp2-F8), which is a bipolar derivation of the frontal region. We segmented the EEG using a 2 s sliding window with 50 % overlap and converted the segments into images. After preprocessing, we fine-tuned ResNet18, pre-trained on ImageNet, and developed an ensemble classification method. In the experiments with 10 epileptic patients (3 - 19 years old) registered in the CHB-MIT scalp EEG database, the results showed that the average sensitivity was 88.73 %, the average specificity was 98.98 %, and the average detection latency time was 7.39 s. In conclusion, the developed algorithm was validated as sufficiently accurate to detect epileptic seizures.Clinical Relevance- This establishes an image recognition algorithm that can detect epileptic seizures using a single- channel frontal EEG.

Gait Evaluation with Bioelectrical Signal Patterns during Cybernic Treatment.

Cybernic treatment with a wearable cyborg Hybrid Assistive Limb for medical use (Medical HAL) improves ambulatory function in patients with progressive neuromuscular diseases. The progress of cybernic treatment is evaluated based on the change in the patient's walking distance and walking speed over a certain treatment period. However, evaluation methods to capture temporal changes in gait functions during each therapy are required for more effective evaluation in clinical practice. Because the patients' muscular activities are measured with each trial of cybernic treatment, bioelectrical signals (BES) of lower limb muscles measured by Medical HAL may aid in evaluating the wearers' gait functions. Thus, this study proposed a method to quantify the BES patterns of patients during cybernic treatment and compared them with the BES patterns of healthy personnel for evaluation, which confirmed the correlation between the BES pattern and the patients' gait abilities. First, we obtained a reference BES pattern from the BES of three healthy personnel during walking using Medical HAL. Second, we calculated the similarity between the reference BES pattern of the healthy personnel and the patient's BES pattern using derivative dynamic time warping (DDTW), which quantified the patients' BES patterns based on their shape. Third, we investigated the correlation between patients' DDTW of BES patterns during cybernic treatment and 2-minute walking distances. The correlation coefficient between the patients was -0.83 (p < 0.01) and that within patients was -0.38 (p < 0.05), indicating a significant BES pattern relationship between walking with Medical HAL and gait abilities. Conclusively, the similarity between the BES patterns of healthy personnel and patients calculated using DDTW might be applied to the evaluation of patients' gait functions. The ability to assess the gait function with data measured during cybernic treatment would provide understandings of the patient's functional changes over time.

Successful Use of the Hybrid Assistive Limb for Care Support to Reduce Lumbar Load in a Simulated Patient Transfer.

STUDY DESIGN: Prospective experimental study in humans. PURPOSE: To determine whether the hybrid assistive limb (HAL) for Care Support can reduce lumbar load during a patient transfer. OVERVIEW OF LITERATURE: The prevalence of work-related low back pain (LBP) among nurses is high. In particular, transferring patients poses a high risk for LBP due to the large lumbar load. Attempts to reduce the lumbar load are crucial to avoid the risk of LBP. Therefore, we investigated the effects of the HAL for Care Support. METHODS: Nineteen volunteers (16 men, three women) lifted a 60-kg doll from a seated position to a standing position. The first transfer was performed without the HAL for Care Support, and the second was performed with the HAL for Care Support assistive robot. We evaluated transfer performance, the visual analog scale (VAS) score for lumbar fatigue, and electromyogram analyses of the trunk and hip. RESULTS: Four participants (two men, two women) succeeded with the HAL for Care Support even though they were unable to perform the task without it. The mean lumbar fatigue VAS score for all participants without the HAL for Care Support was 62 mm, while that with it was 43 mm. With lumbar assistance from the HAL for Care Support, subjective lumbar fatigue during the transfer decreased significantly. A power analysis indicated adequate statistical power to detect a difference in the VAS score for lumbar fatigue (0.99). The activity of the left gluteus maximus alone increased significantly during transfers with the HAL for Care Support. No adverse events occurred during use of the HAL for Care Support for transfers. CONCLUSIONS: The HAL for Care Support was able to reduce lumbar load in a simulated patient transfer.

Cybernic treatment with wearable cyborg Hybrid Assistive Limb (HAL) improves ambulatory function in patients with slowly progressive rare neuromuscular diseases: a multicentre, randomised, controlled crossover trial for efficacy and safety (NCY-3001).

BACKGROUND: Rare neuromuscular diseases such as spinal muscular atrophy, spinal bulbar muscular atrophy, muscular dystrophy, Charcot-Marie-Tooth disease, distal myopathy, sporadic inclusion body myositis, congenital myopathy, and amyotrophic lateral sclerosis lead to incurable amyotrophy and consequent loss of ambulation. Thus far, no therapeutic approaches have been successful in recovering the ambulatory ability. Thus, the aim of this trial was to evaluate the efficacy and safety of cybernic treatment with a wearable cyborg Hybrid Assistive Limb (HAL, Lower Limb Type) in improving the ambulatory function in those patients. RESULTS: We conducted an open-label, randomised, controlled crossover trial to test HAL at nine hospitals between March 6, 2013 and August 8, 2014. Eligible patients were older than 18 years and had a diagnosis of neuromuscular disease as specified above. They were unable to walk for 10 m independently and had neither respiratory failure nor rapid deterioration in gait. The primary endpoint was the distance passed during a two-minute walk test (2MWT). The secondary endpoints were walking speed, cadence, and step length during the 10-m walk test (10MWT), muscle strength by manual muscle testing (MMT), and a series of functional measures. Adverse events and failures/problems/errors with HAL were also evaluated. Thirty patients were randomly assigned to groups A or B, with each group of 15 receiving both treatments in a crossover design. The efficacy of a 40-min walking program performed nine times was compared between HAL plus a hoist and a hoist only. The final analysis included 13 and 11 patients in groups A and B, respectively. Cybernic treatment with HAL resulted in a 10.066% significantly improved distance in 2MWT (95% confidence interval, 0.667-19.464; p = 0.0369) compared with the hoist only treatment. Among the secondary endpoints, the total scores of MMT and cadence at 10MWT were the only ones that showed significant improvement. The only adverse effects were slight to mild myalgia, back pain, and contact skin troubles, which were easily remedied. CONCLUSIONS: HAL is a new treatment device for walking exercise, proven to be more effective than the conventional method in patients with incurable neuromuscular diseases. TRIAL REGISTRATION: JMACTR, JMA-IIA00156.