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IntroductionThe 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.MethodsThis 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.ResultsAll 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.DiscussionIn 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.

Abstract 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.

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.

Abstract 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

Abstract 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.

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.

As an alternative to the paralyzed arm of hemiplegics, if there is a robot arm and hand that is the same size as a human arm and hand, can grasp daily necessities and work cooperatively with the user’s healthy arm, it would help hemiplegics lives. If the weak force on the grasped object and how the grasped object is pulled can be detected on the robot's finger surface, the robot can grasp objects of various hardness with appropriate forces according to the work, prevent dropping the objects and estimate the user’s handling intention to the objects. The purpose of this study is to propose and develop a small and thin tactile force sensor and a calibration method for correcting nonlinearity to realize the measurement of force and its center position on the robot's finger surface irrespective of the loading area and pressure distribution, and to confirm the usefulness through an evaluation experiment. Measuring force regardless of the shape of the object is difficult for conventional sensors because they are affected by the loading area and pressure distribution. Therefore, we developed a small and thin sensor whose contact surface is a single plate unaffected by the object shape. And this sensor has a structure that the capacitance distributions in the sensor are uniquely determined from the applied pressure distribution to calculate the force and its center position. Additionally, we developed its calibration method to correcting uncertain elements due to the nonlinear property. Through the evaluation experiment, we confirmed that the developed sensor can measure the force and its center position. In conclusion, we confirmed that the proposed method can realize a small and thin tactile force sensor capable of measuring force and its center position irrespective of the loading area and pressure distribution.

We hypothesized that a single-leg version of the Hybrid Assistive Limb (HAL) system could improve the gait and physical function of patients with hemiparesis following a stroke. In this pilot study, we therefore compared the efficacy of HAL-based gait training with that of conventional gait training (CGT) in patients with acute stroke. Patients admitted to the participating university hospital were assigned to the HAL group, whereas those admitted to outside teaching hospitals under the same rehabilitation program who did not use the HAL were assigned to the control group. Over 3 weeks, all participants completed nine 20 min sessions of gait training, using either HAL (i.e., the single-leg version of HAL on the paretic side) or conventional methods (i.e., walking aids and gait orthoses). Outcome measures were evaluated before and after the nine training sessions. The Functional Ambulation Category (FAC) was the primary outcome measure, but the following secondary outcome measures were also assessed: National Institutes of Health Stroke Scale, Fugl–Meyer Assessment (Lower Extremity), comfortable walking speed, step length, cadence, 6-min walk distance, Barthel Index, and Functional Independence Measure. In total, 22 post-stroke participants completed the clinical trial: 12 in the HAL group and 10 in the CGT group. No serious adverse events occurred in either group. The HAL group showed significant improvement in FAC after nine sessions when compared with the CGT group (P = 0.014). However, secondary outcomes did not differ significantly between the groups. Our results demonstrate that HAL-based gait therapy may improve independent walking in patients with acute stroke hemiplegia who are dependent on ambulatory assistance. A larger-scale randomized controlled trial is needed to clarify the effectiveness of single-leg HAL therapy.Clinical Trial Registration: UMIN Clinical Trials Registry, identifier UMIN000022410.

Abstract Background The Hybrid Assistive Limb (HAL®) is an exoskeleton wearable robot suit that assists in voluntary control of knee and hip joint motion. There have been several studies on HAL intervention effects in stroke, spinal cord injury, and cerebral palsy. However, no study has investigated HAL intervention for patients with cerebral palsy after surgery. Case presentation We report a case of using HAL in a postoperative patient with cerebral palsy. A 15-year-old boy was diagnosed with spastic diplegia cerebral palsy Gross Motor Function Classification System level IV, with knee flection contracture, equinus foot, and paralysis of the right upper extremity with adduction contracture. He underwent tendon lengthening of the bilateral hamstrings and Achilles tendons. Although the flexion contractures of the bilateral knees and equinus foot improved, muscle strength decreased after the soft tissue surgery. HAL intervention was performed twice during postoperative months 10 and 11. Walking speed, stride, and cadence were increased after HAL intervention. Post HAL intervention, extension angles of the knee in stance phase and hip in the pre-swing phase were improved. In the gait cycle, the proportion of terminal stance in the stance and swing phase was increased. Conclusions Hybrid Assistive Limb intervention for postoperative patients with cerebral palsy whose muscle strength decreases can enhance improvement in walking ability. Further studies are needed to examine the safety and potential application of HAL in this setting.

This paper proposes a novel sit-to-stand and stand-to-sit (STS) training system for hemiplegic patients with clonus. Most hemiplegic patients depend on the unaffected leg and perform plantar flexion involuntarily during STS movements. The developed system integrates a visual biofeedback method with a movement assistance mechanism. The system provides users' ground reaction force (GRF) through a monitor and supports STS movements by moving the seat. We also proposed STS training with physical inhibition by using the developed orthosis to manage clonus. We performed an experiment on a hemiplegic patient who experienced clonus in the affected leg to verify that the user was able to increase the GRF of the heel part (GRFh) of the affected leg while performing STS movements using the system and that the system employing the orthosis reduced clonus. The results showed that GRFh in the intervention test that employed the proposed system was greater than that in the baseline test without the system. We also verified that a significant difference existed between the baseline and intervention test results (p

We report a case in which elbow flexion exercises using the upper limb single-joint Hybrid Assistive Limb (upper limb HAL-SJ) were implemented in a patient 13 months postoperatively following elbow flexion reconstruction with intercostal nerve transfer after a traumatic brachial plexus injury. Treatment using the upper limb HAL-SJ was administered once a week for 10 sessions from 13 to 16 months after surgery. Exercises using the upper limb HAL-SJ supported elbow motion by detecting bioelectric signals through surface electrodes on the biceps and triceps brachii. No adverse events were observed during treatment with the upper limb HAL-SJ. Improvements in elbow flexion strength were observed during treatment. Treatment with the upper limb HAL-SJ can be performed safely and effectively following elbow flexion reconstruction by intercostal nerve transfer after a traumatic brachial plexus injury.

Purpose. We evaluated improvements in gait after using the Hybrid Assistive Limb (HAL®) exoskeleton robot in a patient with late-onset neurological deterioration of lower extremity function after undergoing thoracic spine surgery for a myelopathy due to ossification of the ligamentum flavum. Case Presentation. A 70-year-old man participated in ten 20 min sessions of HAL intervention, twice weekly for five weeks. The effects of each HAL session were evaluated based on changes in performance on the 10 m walk test (10 MWT), lower limb kinematics quantified from motion capture, and the activation ratio of the gastrocnemius, measured before and after the intervention. Muscle activity was recorded using surface electromyography and synchronized to measured kinematics. The HAL intervention improved gait speed and step length, with an increase in the hip flexion angle during the swing phase and a decrease in the activation ratio of the gastrocnemius. The modified Ashworth scale improved from 1+ to 1 and International Standards for Neurological and Functional Classification of Spinal Cord Injury motor scores from 34 to 49. Conclusion. Intervention using the HAL exoskeleton robot may be an effective method to improve functional ambulation in patients with chronic spinal disorders.

Purposes: To evaluate the feasibility of using the single-joint Hybrid Assistive Limb ® robot (HAL) to assist with shoulder flexion-extension in healthy adults, and to assess the capacity of the HAL to analyze the bioelectrical signals of muscle activity for shoulder flexion-extension. Methods: This cross-sectional feasibility study included six healthy adult men with no impairment in shoulder motion. The single-joint HAL was fixed to a custom-designed platform and upper arm attachment, and aligned 3 cm below the acromion process. Vital signs, shoulder fatigue, and shoulder pain were evaluated before and after the shoulder elevation exercise performed with and without the HAL. Activity of selected muscles of the shoulder was recorded using a wireless superficial electromyography device. Shoulder movement was captured using a three-dimensional motion analysis system. Results: The HAL supported smooth flexion-extension of the arm at the shoulder joint, with no negative effects on vital signs, shoulder fatigue, and shoulder pain. The HAL decreased muscle activity levels, with a 55% decrease in trapezius muscle activity. The upward rotation angle of the scapula was significantly lower with the HAL at 120° of shoulder flexion. Conclusion: The single-joint HAL provided safe and effective assistance to scapular plane shoulder flexion-extension among healthy adults.

In order to evaluate sensory disturbance, a subjective method is performed, in which the patient answers orally to the given stimulation. On the other hand, fMRI is a technique for observing brain activity. Therefore fMRI can be used for objective evaluation of sensory disturbance. The purpose of this study is to develop an MR-compatible device which provides both pin and brush stimulations to the surface of the human skin, and to confirm the feasibility of the device by the evaluation of the basic operations and the fMRI trial. The developed device consists of both an MR-compatible stimulator placed inside the MRI room and a driver placed outside the MRI room. The tube-rod mechanism is adopted for power transmission from the driver to the stimulator. For the evaluation of the basic operations, we measure both the pressing force and the period of the pin stimulation, and the stimulation position of the brush stimulation. For the fMRI trial, the MR-compatibility test is performed, and pin and brush stimulations are provided to the hand of a healthy subject. As a result, the standard deviations of the pressing force, period, and position were less than 0.1 N, less than 1.0 ms and less than 0.1 mm. These results were smaller than the standard deviations of manual stimulation by human. Also, MR-compatibility of the device was verified experimentally. Finally, both pin and brush stimulations activated the somatosensory areas. In conclusion, we developed an MR-compatible device which provides both pin and brush stimulations, confirming the feasibility of the device.