Early Initiation of Exoskeletal Robotic Gait Training Improves Functional Outcomes in the Patients with Stroke: A Retrospective Observational Study.

INTRODUCTION: The effect of early initiation of gait training using hybrid assistive limb (HAL) remains unclear. This observational study aimed to investigate whether early initiation of gait training using HAL improves functional outcomes in patients with stroke. METHODS: We retrospectively analyzed patients with acute stroke admitted to our facility. HAL was used for exoskeletal robotic gait training. Study participants were median split into an early group and a late group based on the days from stroke onset to initiation of gait training using HAL. The functional outcomes, defined by the Brunnstrom recovery stage (BRS), modified Rankin Scale (mRS), and Functional Independence Measure (FIM) at discharge, were compared using propensity score-matched analysis. RESULTS: We performed a propensity score-matched analysis in 63 patients with stroke (31 from the early group and 32 from the late group), and 17 pairs were matched. There were no significant differences in discharge in the BRS of the upper limb and finger in the post-matched cohort. On the other hand, the BRS of the lower limb in the early group was significantly higher than that in the late group. In addition, the mRS, but not FIM scores, was significantly better in the early group than that in the late group. CONCLUSIONS: In conclusion, early initiation of gait training using HAL might improve the motor function of the paralyzed lower limb and disability in patients with stroke.

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.

Use of Robot-Assisted Gait Training in Pediatric Patients with Cerebral Palsy in an Inpatient Setting-A Randomized Controlled Trial.

Robot-assisted gait training (RAGT) provides a task-based support of walking using exoskeletons. Evidence shows moderate, but positive effects in the therapy of patients with cerebral palsy (CP). This study investigates the impact of RAGT on walking speed and gait parameters in pediatric CP patients. Thirty subjects (male = 23; female = 7), with a mean age of 13.0 ± 2.5 (9-17) years, and with spastic CP, were recruited. The intervention group (n = 15) underwent six 20-minute RAGT sessions with the Hybrid Assistive Limb (HAL) during an 11-day hospital stay. Additionally, a therapy concept including physiotherapy, physician-performed manual medicine, massage and exercise therapy was provided. The control group (n = 15) was treated with the therapy concept only. The outcome was based on a 10-Metre Walking Test (10MWT), 6-Minute Walking Test (6MWT), Gross Motor Function Measure (GMFM-88) and lower extremities passive range of motion. The intervention group achieved a mean increase in walking speed in the 10MWT (self-selected walking speed SSW) of 5.5 s (p = 0.378). There were no significant differences between the groups in the 10MWT (max) (p = 0.123) and the 6MWT (p = 0.8). Changes in the GMFM (total) and in the dimension standing and walking, running and jumping (D + E) showed clinically relevant significant results (p = 0.002 and p = 0.046). RAGT as a supplement to an inpatient therapy stay appears to have a positive, yet not significant impact on the gait parameters of pediatric CP patients as well as motivating them to practice walking. Further studies with adapted study designs are needed to evaluate different influencing factors.

Clinical Prediction Rule for Identifying the Stroke Patients who will Obtain Clinically Important Improvement of Upper Limb Motor Function by Robot-Assisted Upper Limb.

BACKGROUND: The number of studies on the characteristics of patients with stroke who would benefit from robot-assisted upper limb rehabilitation is limited, and there are no clear criteria for determining which individuals should receive such treatment. The current study aimed to develop a clinical prediction rule using machine learning to identify the characteristics of patients with stroke who can the achieve minimal clinically important difference of the Fugl-Meyer Upper Extremity Evaluation (FMA-UE) after single-joint hybrid assistive limb (HAL-SJ) rehabilitation. METHODS: This study included 71 patients with subacute stroke who received HAL-SJ rehabilitation. The chi-square automatic interaction detector (CHAID) model was applied to predict improvement in upper limb motor function. Based the analysis using CHAID, age, sex, days from stroke onset to the initiation of HAL-SJ rehabilitation, and upper limb motor and cognitive functions were used as independent variables. Improvement in upper limb motor function was determined based on the minimal clinically important difference of the FMA-UE, which was used as a dependent variable. RESULTS: According to the CHAID model, the FMA-UE score during the initiation of HAL-SJ rehabilitation was the most significant predictive factor for patients who are likely to respond to the intervention. Interestingly, this therapy was more effective in patients with moderate upper limb motor dysfunction and early initiation of HAL-SJ rehabilitation. The accuracy of the CHAID model was 0.89 (95% confidence interval: 0.81-0.96). CONCLUSION: We developed a clinical prediction rule for identifying the characteristics of patients with stroke whose upper limb motor function can improve with HAL-SJ rehabilitation.

Rehabilitation during early postoperative period following total knee arthroplasty using single-joint hybrid assistive limb as new therapy device: a randomized, controlled clinical pilot study.

INTRODUCTION: The first weeks after total knee arthroplasty (TKA) are crucial for the functional outcome. To improve knee mobility, a continuous passive motion (CPM) motor rail is commonly used during in-hospital rehabilitation. The single-joint hybrid assistive limb (HAL-SJ) is a new therapy device. The aim of the study was to improve patients' range of motion (ROM), mobility, and satisfaction using the active-assistive support of the HAL-SJ. MATERIALS AND METHODS: Between 09/2017 and 10/2020, 34 patients, who underwent TKA and matched the inclusion criteria, were randomized into study (HAL-SJ) and control (CPM) group. Treatment began after drain removal and was carried out until discharge. Primary outcome parameters were raised pre- and postoperatively and included the Oxford knee score (OKS), visual analog scale (VAS), and acquired range of motion. Furthermore complications caused by the device were recorded. RESULTS: OKS increased in both groups postoperatively, but only significantly in the HAL-SJ group. Postoperative pain improved in both groups without significant differences. Flexion improvement was significant in both groups between days 3/7 and 8 weeks postoperatively. We did not encounter any complications related to HAL-SJ. CONCLUSIONS: In conclusion, use of the HAL-SJ during rehabilitation in the early postoperative period after TKA was safe without disadvantages compared to the control group and seems to have advantages in terms of daily life impairment.

Development of a New Ankle Joint Hybrid Assistive Limb.

Foot and ankle disabilities (foot drop) due to common peroneal nerve palsy and stroke negatively affect patients' ambulation and activities of daily living. We developed a novel robotics ankle hybrid assistive limb (HAL) for patients with foot drop due to common peroneal nerve palsy or stroke. The ankle HAL is a wearable exoskeleton-type robot that is used to train plantar and dorsiflexion and for voluntary assistive training of the ankle joint of patients with palsy using an actuator, which is placed on the lateral side of the ankle joint and detects bioelectrical signals from the tibialis anterior (TA) and gastrocnemius muscles. Voluntary ankle dorsiflexion training using the new ankle HAL was implemented in a patient with foot drop due to peroneal nerve palsy after lumbar surgery. The time required for ankle HAL training (from wearing to the end of training) was approximately 30 min per session. The muscle activities of the TA on the right were lower than those on the left before and after ankle HAL training. The electromyographic wave of muscle activities of the TA on the right was slightly clearer than that before ankle HAL training in the resting position immediately after ankle dorsiflexion. Voluntary ankle dorsiflexion training using the novel robotics ankle HAL was safe and had no adverse effect in a patient with foot drop due to peroneal nerve palsy.

Postoperative Acute-Phase Gait Training Using Hybrid Assistive Limb Improves Gait Ataxia in a Patient with Intradural Spinal Cord Compression Due to Spinal Tumors.

Sensory ataxia due to posterior cord syndrome is a relevant, disabling condition in nontraumatic spinal cord dysfunction. Ataxic gait is a common symptom of sensory ataxia that restricts activities of daily living. A 70-year-old woman with severe sensory disturbance was diagnosed with intradural extramedullary spinal cord tumors found in the thoracic spine region (T8). Surgical management of the tumors was performed. The patient received gait training 20 days after surgery (postoperative acute phase) using a hybrid assistive limb (HAL). HAL is a wearable exoskeleton cyborg that provides real-time assistance to an individual for walking and limb movements through actuators mounted on the bilateral hip and knee joints. Walking ability was assessed using the 10 m walking test, which included evaluating walking speed, step length, and cadence in every session. To evaluate the immediate effects of HAL training, walking speed and step length were measured before and after the training in each session. During the 10 m walking test, gait kinematics and lower muscle activity were recorded using a motion capture system and wireless surface electromyography before the first session and after completion of all HAL sessions. After the HAL training sessions, improvement in the patient's gait performance was observed in the gait joint angles and muscle activity of the lower limb. After 10 training sessions, we observed the following changes from baseline: walking speed (from 0.16 m/s to 0.3 m/s), step length (from 0.19 m to 0.37 m), and cadence (from 50.9 steps/min to 49.1 steps/min). The average standard deviations of the knee (from right, 7.31; left, 6.75; to right, 2.93; p < 0.01, left, 2.63; p < 0.01) and ankle joints (from right, 6.98; left, 5.40; to right, 2.39; p < 0.01, left, 2.18; p < 0.01) were significantly decreased. Additionally, walking speed and step length improved immediately after completing all the HAL training sessions. This suggests that HAL gait training might be a suitable physical rehabilitation program for patients with sensory ataxia causing dysfunctional movement of the lower limb.

Ankle dorsiflexion training with a newly developed Hybrid Assistive Limb for a patient with foot drop caused by common peroneal nerve palsy: a case report.

[Purpose] An ankle disorder (foot drop) caused by common peroneal nerve palsy or cerebrovascular accident (stroke) interferes with patients' ability to walk and hinders in activities of daily living. A new robotic ankle, the Hybrid Assistive Limb, has been developed for the treatment of foot drop caused by common peroneal nerve palsy or sequelae of stroke. The purpose in this study was to report and examine the efficacy and feasibility of a case who was treated with voluntary ankle dorsiflexion training with the ankle Hybrid Assistive Limb. [Participant and Method] A 60-year-old man with foot drop due to peroneal nerve palsy that occurred without a contributory cause was treated via ankle dorsiflexion training with the use of a new robotic ankle, the "Ankle Hybrid Assistive Limb". [Results] Following total ankle rehabilitation training with the Ankle Hybrid Assistive Limb, improvements in ankle dorsiflexor strength, gait, and sensory function of the lower leg and foot were observed. [Conclusion] The newly developed ankle Hybrid Assistive Limb could be an effective training tool for foot drop caused by common peroneal nerve palsy.

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.

Effect of hybrid assistive limb treatment on maximal walking speed and six-minute walking distance during stroke rehabilitation: a pilot study.

[Purpose] In stroke rehabilitation, gait assessment measures the maximal walking speed and six-minute walking distance, both of which have not been thoroughly investigated as determinants of walking ability. Here, we assessed the methods for evaluating these gait parameters using clinical data on hybrid assistive limb treatment compared with conventional training. [Participants and Methods] In total, 20 stroke patients (hybrid assistive limb group, n=9; conventional group, n=11) participated in this randomized controlled trial. For 12 sessions (three times per week in 4 weeks), the hybrid assistive limb and conventional groups performed gait treatment with hybrid assistive limb and conventional gait training, respectively. Short physical performance battery and walking ability (maximal walking speed and six-minute walking distance) were evaluated pre- and post-intervention. Subsequently, the patients were divided further into two groups: low- and high-balance score groups. [Results] Maximum walking speed and six-minute walking distance were significantly associated, with a positive relationship observed post-intervention. The high-balance score group showed a significant improvement in the six-minute walking distance compared to the low-balance score group. However, no significant improvement in maximum walking speed was observed between both groups. [Conclusion] Due to its sensitivity in detecting differences in balance, six-minute walking distance may be a useful assessment parameter for stroke rehabilitation, particularly in the recovery of physiological walking ability.

Rehabilitation training using a single-joint type hybrid assistive limb for the knee after anterior cruciate ligament reconstruction: an initial case report indicating safety and feasibility.

[Purpose] The aim of this report was to describe the safety, feasibility, and efficacy of rehabilitation by knee extension and flexion training using the knee single-joint hybrid assistive limb in a patient after anterior cruciate ligament reconstruction. [Participant and Methods] A 33 year-old male underwent an arthroscopic procedure for anatomic single-bundle anterior cruciate ligament reconstruction with a semitendinosus tendon autograft. Rehabilitation training using the knee single-joint hybrid assistive limb was initiated at postoperative week 18 and repeated weekly for 3 weeks. The patient performed five sets of the knee single-joint hybrid assistive limb-assisted knee-extension-flexion exercises per session at a frequency of 10 exercises/set. [Results] The peak extension torque at all velocities with the limb symmetry index was higher after the hybrid assistive limb intervention (post-intervention) than before using it (pre-intervention). Peak flexion torques at 60°/s and 300°/s of limb symmetry index were higher post-intervention than pre-intervention. The range of motion in extension and flexion improved from -2° (pre-intervention) to -1° (post-intervention) and from 124° to 133°, respectively. The Lysholm score increased from 58 (pre-intervention) to 94 (post-intervention). [Conclusion] The knee single-joint hybrid assistive limb can be used safely for anterior cruciate ligament reconstruction training, without any adverse events. Our results indicate that the knee single-joint hybrid assistive limb training may improve muscle function, effectively overcoming dysfunction.

Effects of Exoskeletal Lower Limb Robot Training on the Activities of Daily Living in Stroke Patients: Retrospective Pre-Post Comparison Using Propensity Score Matched Analysis.

PURPOSE: There is limited evidence of gait training using newly developed exoskeletal lower limb robot called Hybrid Assistive Limb (HAL) on the function and ability to perform ADL in stroke patients. In clinical settings, we frequently find it challenging to conduct a randomized controlled trial; thus, a large-scale observational study using propensity score analysis methods is a feasible alternative. The present study aimed to determine whether exoskeletal lower limb robot training improved the ability to perform ADL in stroke patients. MATERIALS AND METHODS: Acute stroke patients who were admitted to our facility from April 2016 to March 2017 were evaluated in the conventional rehabilitation period (CRP) and those admitted from April 2017 to June 2019 were evaluated in the HAL rehabilitation period (HRP). We started a new gait rehabilitation program using HAL at the midpoint of these two periods. The functional outcomes or ADL ability outcomes of the patients in the CRP and the subsequent HRP were compared using propensity score matched analyses. RESULTS: Propensity score matching analysis was performed for 108 stroke patients (63 from the CRP and 45 from the HRP), and 36 pairs were matched. The ADL ability, defined by the FIM scores and FIM score change, was significantly higher in patients admitted during the HRP. In addition, more stroke patients obtained practical walking ability during hospitalization in the HRP. CONCLUSION: Gait training using HAL affects the ADL ability and obtaining of practical walking ability of stroke patients.

Effect of the Hybrid Assistive Limb on the Gait Pattern for Cerebral Palsy.

Background and objectives: Cerebral palsy (CP) is the most frequent childhood motor disability. Achieving ambulation or standing in children with CP has been a major goal of physical therapy. Recently, robot-assisted gait training using the Hybrid Assistive Limb® (HAL) has been effective in improving walking ability in patients with CP. However, previous studies have not examined in detail the changes in gait pattern after HAL training for patients with spastic CP, including gait symmetry. This study aimed to evaluate the immediate effect of HAL training on the walking ability and the changes in gait pattern and gait symmetry in patients with spastic CP. Materials and Methods: We recruited 19 patients with spastic CP (13 male and six female; mean age, 15.7 years). Functional ambulation was assessed using the 10-Meter Walk Test and gait analysis in the sagittal plane before and after a single 20-min HAL intervention session. Results: The walking speed and stride length significantly increased after HAL intervention compared to the pre-intervention values. Two-dimensional gait analysis showed improvement in equinus gait, increase in the flexion angle of the swing phase in the knee and hip joints, and improvement in gait symmetry. Immediate improvements in the walking ability and gait pattern were noted after HAL training in patients with spastic CP. Conclusions: The symmetry of the joint angle of the lower limb, including the trunk, accounts for the improvement in walking ability after HAL therapy.

Dropped Head Syndrome Attenuation by Hybrid Assistive Limb: A Preliminary Study of Three Cases on Cervical Alignment during Walking.

Background and Objectives: Dropped head syndrome (DHS) is characterized by apparent neck extensor muscle weakness and difficulty in extending the neck to raise the head against gravity. DHS affects forward vision and eating behavior, and hence impairs quality of life. However, standardized treatment of DHS has not yet been established. The purpose of this preliminary study is to seek for a possibility of effective non-surgical, conservative treatment for DHS, by applying a robotic treatment. Materials and Methods: A wearable exoskeleton type robot suit hybrid assistive limb (HAL) was applied to three patients with DHS. A course of HAL treatment included 10 sessions of gait training using HAL. One session lasted about an hour. Case 1 completed the course twice, the first time in two weeks (one session per day) and second time in 10 months (one session per month). Case 2 and Case 3 completed the course once in 10 weeks (one session per week) and in 6 months (one session per 2.5 weeks), respectively. Immediate and lasting effects of HAL on the reduction of cervical sagittal vertical alignment (SVA) during gait was evaluated using a motion capture system. Results: Case 1 showed improvement of cervical alignment during gait after the HAL courses of both different frequencies. Case 2 did not show improvement of cervical alignment during gait. Case 3 showed improvement of cervical kyphosis but not of cervical sagittal alignment during gait. Conclusions: The results of the preliminary study suggest that gait training using HAL may be an effective option of conservative treatment for a part of DHS patients. They also suggest that a lack of immediate effects on the cervical alignment and a lack of ability to perform compensatory trunk motion may indicate a non-responding patient. Generalization of the results requires further research with more cases.

Robotic rehabilitation of the paralyzed upper limb for a stroke patient using the single-joint hybrid assistive limb: a case study assessed by accelerometer on the wrist.

[Purpose] Recent studies have reported the effectiveness of robotic rehabilitation of paralyzed upper limbs in stroke patients. For example, the Single-Joint Hybrid Assistive Limb has been shown to improve upper limb impairments. However, limited data are available on the effectiveness of robotic rehabilitation of the upper limb with regards to daily living. In this case study, an accelerometer was adopted to examine whether rehabilitation using the Single-Joint Hybrid Assistive Limb improved upper limb activity during daily living in a stroke patient. [Participant and Methods] The participant was a 69-year-old male diagnosed with stroke and left hemiparesis. The Single-Joint Hybrid Assistive Limb was applied to the participant's elbow on the paralyzed side. The participant wore an accelerometer on each wrist to measure the activities of the upper limbs. Clinical tests of the paralyzed upper limb were also performed. [Results] The activity of the paralytic limb was significantly higher after Single-Joint Hybrid Assistive Limb intervention than before the intervention. On the other hand, none of the results of the clinical tests changed beyond a clinically important difference. [Conclusion] The Single-Joint Hybrid Assistive Limb could be useful for promoting active use of a paralyzed upper limb in daily living. In addition, an accelerometer could be especially useful for evaluating the effects of robotic rehabilitation.

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.

Combination of Exoskeletal Upper Limb Robot and Occupational Therapy Improve Activities of Daily Living Function in Acute Stroke Patients.

PURPOSE: Previous studies have suggested that upper limb rehabilitation using therapeutic robots improves motor function of stroke patients. However, the effect of upper limb robotic rehabilitation on improving functioning in activities of daily living (ADL) remains unclear. The present study aimed to determine whether upper limb rehabilitation using single joint Hybrid Assistive Limb (HAL-SJ) affects ADL function and the use of a hemiparetic arm in ADLs of acute stroke patients. MATERIALS AND METHODS: Twelve acute stroke patients participated in the study and were randomly divided into group A or group B. The patients in group A followed an A-B-A-B design and those in group B followed a B-A-B-A design. The patients received combination HAL-SJ and occupational therapy during A and conventional occupational therapy during B. RESULTS: Upper limb motor function and ADLs, in particular, dressing the upper body, were improved during combination HAL-SJ and occupational therapy. Interestingly, the use of a hemiparetic arm in daily life evaluated using the motor activity log was also significantly improved during A in group A. CONCLUSIONS: Combination HAL-SJ and occupational therapy affects ADL function and real use of a hemiparetic arm in the daily life of acute stroke patients.

A Consecutive 25-Week Program of Gait Training, Using the Alternating Hybrid Assistive Limb (HAL®) Robot and Conventional Training, and Its Effects on the Walking Ability of a Patient with Chronic Thoracic Spinal Cord Injury: A Single Case Reversal Design.

Background and Objectives: In this study, we examined the effect of a consecutive 25-week gait training program, consisting of 5-week alternating phases of Hybrid Assistive Limb (HAL)-assisted robot gait training and conventional gait training, on the walking ability of a 50-year-old man with a chronic thoracic spinal cord injury (SCI). Materials and Methods: Clinical features of this patient's paraplegia were as follows: neurological level, T7; American Spinal Cord Injury Association Impairment Scale Score, C; Lower Extremity Motor Score, 20 points; Berg Balance Scale score, 15 points; and Walking Index for Spinal Cord Injury, 6 points. The patient completed a 100 m walk, under close supervision, using a walker and bilateral ankle-foot orthoses. The intervention included two phases: phase A, conventional walking practice and physical therapy for 5 weeks, and phase B, walking using the HAL robot (3 d/week, 30 min/session), combined with conventional physical therapy, for 5 weeks. A consecutive A-B-A-B-A sequence was used, with a 5-week duration for each phase. Results: The gait training intervention increased the maximum walking speed, cadence, and 2-min walking distance, as well as the Berg Balance and Walking Index for Spinal Cord Injury from 15 to 17 and 6 to 7, respectively. Walking speed, stride length, and cadence improved after phase A (but not B). Improved standing balance was associated with measured improvements in measured gait parameters. Conclusion: The walking ability of patients with a chronic SCI may be improved, over a short period by combining gait training, using HAL-assisted and conventional gait training and physical therapy.