Hybrid Assistive Limb Research Articles

Microstructural white matter changes following gait training with Hybrid Assistive Limb initiated within 1 week of stroke onset

The early initiation of robot-assisted gait training in patients with acute stroke could promote neuroplasticity. The aim of this study was to clarify the microstructural changes of white matter associated with gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI). Patients with first-ever stroke and requiring a walking aid started gait training within 1 week of stroke onset. The patients were quasi-randomly assigned either to the conventional physical therapy (CPT) group or gait training using HAL (HAL) group. Motor function and DTI were examined at baseline and after 3–5 months. Voxel-based statistical analyses of fractional anisotropy (FA) images were performed using diffusion metric voxel-wise analyses. Volume of interest (VOI)-based analyses were used to assess changes in FA (ΔFA). Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study. There were improvements in motor function and independency in the CPT and HAL groups (p < .001). Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, −0.066/−0.027, p = .027; corpus callosum, 0.002/0.042, p < .001). Gait training using HAL initiated within 1 week after stroke onset facilitated the recovery of inter-hemispheric communication and prevented the progression of Wallerian degeneration of the affected pyramidal tract.

Feasibility of supplemental robot-assisted knee flexion exercise following total knee arthroplasty.

The Hybrid Assistive Limb (HAL) is a robotic exoskeleton designed to support impaired limbs. We aimed to evaluate whether active exercise using a single-joint HAL (HAL-SJ) following total knee arthroplasty can facilitate the recovery of knee flexion. Twenty-two patients who underwent total knee arthroplasty were randomly allocated to the HAL-SJ group (n= 12) or conventional physical therapy (CPT) group (n= 10). On postoperative day 5, patients performed active knee flexion exercises either with or without HAL-SJ assistance every second day. Outcome measures included active and passive knee flexion range of motion (ROM), muscle strength, and pain intensity, as assessed by the visual analog scale, and were assessed on postoperative days 5 (pre-treatment) and 10 (post-treatment). Active ROM was measured at 6months postoperatively; further long-term follow-up was performed by telephone interview. Both groups showed significant improvement between postoperative days 5 and 10 in all outcome measures. Improvements in active ROM (p< 0.01), passive ROM (p< 0.01), muscle strength (p< 0.01), and pain (p< 0.01) were significantly greater in the HAL-SJ group than in the CPT group. Long-term outcomes were also significantly better in the HAL-SJ group. HAL therapy enables patients to perform painless active movements and facilitates the recovery of knee function.

Biofeedback Core Exercise Using Hybrid Assistive Limb for Physical Frailty Patients With or Without Parkinson's Disease.

Introduction: Elderly people often exhibit “frailty,” and motor dysfunction occurs. Several studies have reported about the relationship between motor dysfunction and frailty in Parkinson's disease (PD). This study aimed to test whether the core exercise using the hybrid assistive limb lumbar type for care support (HAL-CB02) may improve the motor functions in frailty patients with or without PD and to explore the optimal patient selection from the frailty cohort.Materials and Methods: We recruited 16 frailty patients (PD = 8; non-PD = 8). The participants performed core exercise and squats using HAL-CB02 for five sessions a week. Outcome measures were 10-m walking test, step length, timed up-and-go test, 30-s chair stand test, and visual analog scale. Evaluation was conducted at baseline, post-exercise, and 1- and 3-month follow-ups.Results: Both PD and non-PD patients showed significant improvement in all evaluation items post-exercise. Moreover, no significant difference was found in the improvement value between the two groups.Conclusions: Our results suggest that biofeedback exercise with HAL-CB02 is a safe and promising treatment for frailty patients. Motor dysfunction in PD patients may be partly due to physical frailty, and biofeedback exercise with HAL-CB02 is proposed as a treatment option.

Muscular Activity Modulation During Post-operative Walking With Hybrid Assistive Limb (HAL) in a Patient With Thoracic Myelopathy Due to Ossification of Posterior Longitudinal Ligament: A Case Report.

Disorders of the central nervous system sometimes cause severe sensory motor paralysis accompanied by gait impairment. Recently, there are several reports on the effectiveness of robot-assisted gait training for patients experiencing these issues. The purpose of this case report was to assess the neuromechanical effect of a wearable robot suit HAL (Hybrid Assistive Limb) during post-operative gait training in a patient with gait impairment due to compressive myelopathy caused by ossification of the posterior longitudinal ligament (OPLL). For this purpose, we compared lower limb muscular activities while the patient was walking with and without the robot through a course of treatment sessions by (i) gait phase-dependent muscle usage analysis, (ii) muscle synergy analysis, and (iii) muscle network analysis. The results show (i) enhanced activity of the extensor muscles for weight-bearing in the initial sessions by using HAL and reduced knee extensor and increased hip extensor activations for achieving larger steps and faster gait in the later sessions; (ii) involvement of a greater number of synergies during walking with HAL than without HAL; and (iii) modulated muscle network property during walking with HAL remaining until the next HAL session. The patient's gait was improved after completing HAL sessions, acquiring close to normal joint profile with greater range of joint movement, faster walking speed, and larger step length. We discuss that the muscular activity modulation during walking with HAL suggests altered control of the muscles by the central nervous system during post-operative walking. Activity-dependent sensorimotor augmentation by HAL is discussed in the context of recovery of gait control by the central nervous system. The relationship between the altered control and the achieved gait recovery requires further investigation.

A randomized controlled study incorporating an electromechanical gait machine, the Hybrid Assistive Limb, in gait training of patients with severe limitations in walking in the subacute phase after stroke.

Early onset, intensive and repetitive, gait training may improve outcome after stroke but for patients with severe limitations in walking, rehabilitation is a challenge. The Hybrid Assistive Limb (HAL) is a gait machine that captures voluntary actions and support gait motions. Previous studies of HAL indicate beneficial effects on walking, but these results need to be confirmed in blinded, randomized controlled studies. This study aimed to explore effects of incorporating gait training with HAL as part of an inpatient rehabilitation program after stroke. Thirty-two subacute stroke patients with severe limitations in walking were randomized to incorporated HAL training (4 days/week for 4 weeks) or conventional gait training only. Blinded assessments were carried out at baseline, after the intervention, and at 6 months post stroke. The primary outcome was walking independence according to the Functional Ambulation Categories. Secondary outcomes were the Fugl-Meyer Assessment, 2-Minute Walk Test, Berg Balance Scale, and the Barthel Index. No significant between-group differences were found regarding any primary or secondary outcomes. At 6 months, two thirds of all patients were independent in walking. Prediction of independent walking at 6 months was not influenced by treatment group, but by age (OR 0.848, CI 0.719-0.998, p = 0.048). This study found no difference between groups for any outcomes despite the extra resources required for the HAL training, but highlights the substantial improvements in walking seen when evidence-based rehabilitation is provided to patients, with severe limitations in walking in the subacute stage after stroke. In future studies potential subgroups of patients who will benefit the most from electromechanically-assisted gait training should be explored.

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

Study DesignProspective experimental study in humans.PurposeTo determine whether the hybrid assistive limb (HAL) for Care Support can reduce lumbar load during a patient transfer.Overview of LiteratureThe 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.MethodsNineteen 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.ResultsFour 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.ConclusionsThe HAL for Care Support was able to reduce lumbar load in a simulated patient transfer.

Hybrid Assistive Limb improves restricted hip extension after total hip arthroplasty

ABSTRACT The Hybrid Assistive Limb (HAL) was developed as an exoskeleton robot that supports gait training. The purpose of this study was to assess the usefulness of training using the HAL after total hip arthroplasty (THA). We targeted 16 consecutive patients who underwent THA via the posterior approach. We randomized patients to the HAL group (8 hips), in which the HAL was used as part of physical therapy, or the control group (8 hips), in which only typical physical therapy was performed. Gait analysis was performed before and after surgery, and comparisons were made between the two groups. We evaluated the single support time (%), double support time (%), cadence (steps/min), velocity (cm/s), stride length (cm), and anteroposterior and lateral variability, and assessed the hip and knee joint range of motion in the sagittal plane. The results showed improvements in the hip extension angle and other gait parameters in the HAL group. Among gait-related problems after THA, a decreased peak hip extension angle is reported to be a significant factor that affects gait disability. This study revealed that HAL usage after THA seems to be a useful method to obtain sufficient extension angle.

Effects of Gait Treatment With a Single-Leg Hybrid Assistive Limb System After Acute Stroke: A Non-randomized Clinical Trial.

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.

A case of Charcot–Marie–Tooth disease in which gait training was performed with a hybrid assistive limb (HAL)

A case of Charcot–Marie–Tooth disease in which gait training was performed with a hybrid assistive limb (HAL)

Gait training using a hybrid assistive limb (HAL) for myotonic dystrophy type 1

Gait training using a hybrid assistive limb (HAL) for myotonic dystrophy type 1

Feasibility of Robot-assisted Rehabilitation in Poststroke Recovery of Upper Limb Function Depending on the Severity.

The single-joint Hybrid Assistive Limb (HAL-SJ) robot is an exoskeleton-type suit developed for the neurorehabilitation of upper limb function. Several studies have addressed the usefulness of the robot; however, the appropriate patient selection remains unclear. In this study, we evaluated the effectiveness of the HAL-SJ exoskeleton in improving upper limb function in the subacute phase after a stroke, as a function of the severity of arm paralysis. Our analysis was based on a retrospective review of 35 patients, treated using the HAL-SJ exoskeleton in the subacute phase after their stroke, between October 2014 and December 2018. The severity of upper limb impairment was quantified using the Brunnstrom recovery stage (BRS) as follows: severe, BRS score 1–2, n = 10; moderate, BRS 3–4, n = 12; and mild, BRS 5–6, n = 13. The primary endpoint was the improvement in upper limb function, from baseline to post-intervention, measured using the Fugl-Meyer assessment upper limb motor score (ΔFMA-UE; range 0–66). The ΔFMA-UE score was significant for all three severity groups (P <0.05). The magnitude of improvement was greater in the moderate group than in the mild group (P <0.05). The greatest improvement was attained for patients with a moderate level of upper limb impairment at baseline. Our findings support the feasibility of the HAL-SJ to improve upper limb function in the subacute phase after a stroke with appropriate patient selection. This study is the first report showing the effect of robot-assisted rehabilitation using the HAL-SJ, according to the severity of paralysis in acute stroke patients with upper extremity motor deficits.

A case of robotic rehabilitation with a single-joint hybrid assistive limb for lower extremity paresis after surgery for thoracic ossification of the posterior longitudinal ligament

A case of robotic rehabilitation with a single-joint hybrid assistive limb for lower extremity paresis after surgery for thoracic ossification of the posterior longitudinal ligament

Self-perceived functioning and disability after randomized conventional and electromechanically-assisted gait training in subacute stroke: A 6 months follow-up

Few previous studies have assessed self-perceived functioning, disability and recovery after electromechanically-assisted gait training (EAGT). To compare self-perceived functioning, disability and recovery after EAGT and after conventional gait training in the subacute stage after stroke, using the Stroke Impact Scale (SIS), and factors associated with self-perceived recovery, assessed at 6 months after stroke. Patients were randomized into two groups performing a 4-week intervention period of incorporated EAGT using the Hybrid Assistive Limb (HAL) or conventional physiotherapy only. There were no significant differences in self-perceived strength, ADL, mobility, participation and percentage of recovery between intervention groups (p > 0.05). Self-perceived mobility was associated with improvements in objectively assessed walking speed/endurance and balance (R2 0.717, p = 0.002), and self-perceived recovery with self-perceived activities of daily living (ADL) ability (R2 0.34, p = 0.001). This study indicates that EAGT and conventional gait training in the subacute stage after stroke have no differential impact on self-perceived functioning, disability and recovery at 6 months after stroke. Further, the study highlights the importance of interventions targeting ADL and self-care independence during stroke rehabilitation to enhance self-perceived recovery and clinical aspects to be targeted to enhance perceived mobility.

Safety and immediate effects of Hybrid Assistive Limb in children with cerebral palsy: A pilot study

PurposeEarly intervention is effective for developing motor ability and preventing contractures and deformities in patients with cerebral palsy (CP). Gait training using the newly developed Hybrid Assistive Limb (HAL) shows promise as an intervention to prevent deterioration in walking ability and deformities in pediatric CP patients. The purpose of this pilot study was to examine the safety and immediate effects on walking ability after gait training using the HAL in pediatric CP patients. MethodsNineteen patients (six females, 13 males; mean age 8.5 years; mean height 120.5 cm; mean weight 23.2 kg) were enrolled. The Gross Motor Functional Classification Scale level was I in two patients, II in two, III in eight, and IV in seven. The HAL was used for a single session of gait training. The primary outcome was safety of the HAL for use in pediatric CP patients. The secondary outcome was the immediate effect after gait training with HAL, evaluated by passive range of motion (ROM) and gait parameters, including gait speed (m/s), step length (cm), and cadence (step/min). ResultsAll 19 patients were able to carry out the gait training without any severe adverse events. Significant improvements were observed for mean internal/external rotation and abduction angles of the hip joint, and ankle dorsiflexion angles (n = 19). Significant improvements were observed for mean gait speed and step length based on expansion of the hip flexion-extension range (n = 11). ConclusionGait training using the HAL is safe and can produce immediate improvements in ROM and walking ability in pediatric patients with CP.

Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial.

BackgroundGait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration.ObjectiveThis study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation.MethodsThis is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention.ResultsThis study began in November 2016 and is being conducted at 15 participating facilities in Japan.ConclusionsAssessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting.Trial RegistrationUMIN Clinical Trials Registry UMIN000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545

A pilot study to explore the safety and efficacy of hybrid assistive limb for acute stroke

A pilot study to explore the safety and efficacy of hybrid assistive limb for acute stroke

Comparison of a cluster-based foot model with the Oxford foot model and Rizzoli foot model to measure pronation-related kinematics

The Hybrid Assistive Limb Lumbar Type (HAL) is an active exoskeleton that provides motion according to the wearer’s voluntary drive. It was developed to support back muscles during repetitive lifting tasks. The purpose of this paper was to determine if the myoelectric activity of the back muscles is reduced or altered when using the HAL and to investigate a possible influence of its use on the cardiovascular system. Fourteen healthy young men without lower back pain underwent a freestyle, symmetrical-lifting protocol. Participants lifted a 17.05 kg handled-box for 10 min. with and without HAL support. Surface electromyography (sEMG) signals were recorded at thoracic (TES) and lumbar erector spinae (LES) and quadriceps femoris (QF). Heart rate was recorded from electrocardiogram. The subjects rated their level of physical exertion using the Borg Rating of Perceived Exertion (BORG) scale. Additionally they commented on sites of discomfort, perceptions of force, and loss of range of motion. The root mean square and integrated sEMG value was significantly reduced at the LES and TES. Heart rate variability output variables did not show any significant difference. The BORG-Scale showed no difference, with a mean score of 2.5. The HAL decreased the magnitude and onset of muscle activity and force in the lower back in a repetitive lifting task. Reduction of the muscle force and activity required during the lifting process is meaningful regarding lower back pain prevention, and the HAL may contribute to reducing the incidence of lower back pain in the working population.

A follow-up study of the effect of training using the Hybrid Assistive Limb on Gait ability in chronic stroke patients

ABSTRACTObjectives: Recently, use of the Hybrid Assistive Limb (HAL) that is effective for improvement of gait ability in chronic stroke patients has been reported. However, how long the effects are maintained remains unknown. The purpose of the present study was to investigate whether the effect of gait training using the HAL on gait ability was maintained for 3 months after the intervention.Methods: A longitudinal, observational study with an intervention for a single group that adhered to the STROBE guidelines was performed. Nine chronic stroke patients were enrolled in this study. The patients performed gait training sessions using the HAL, 2–5 sessions/week for 3 weeks. Gait speed, stride length, cadence, and 2-minute walk distance (2MWD) were measured before and after intervention and at 3-month follow-up. The clinical trial registration number of this study is UMIN000012764 R000014756.Results: Compared to the initial status, gait speed (p = .02), stride length (p = .03), cadence (p = .01), and 2MWD (p < .05) were significantly increased immediately after the intervention. Moreover, gait speed (p < .01), cadence (p = .03), and 2MWD (p = .02) remained significantly higher 3 months after the intervention. There were no significant changes in all outcome measures between after intervention and at 3-month follow-up.Conclusions: This study showed that gait training using the HAL resulted in significant improvement of gait ability after the intervention and the effect was maintained for 3 months after the training.

Acute stroke rehabilitation for gait training with cyborg type robot Hybrid Assistive Limb: A pilot study

Robot-assisted gait training following acute stroke could allow patients with severe disability to receive a high dosage and intensity of gait training compared with conventional physical therapy (CP). However, given the limited data on gauging the efficacy of Hybrid Assistive Limb (HAL) on gait training in patients with acute stroke, we aimed to evaluate several outcome measures following gait training with HAL. Patients with first-ever stroke, who required a walking aid and were able to start gait training within 1 week of stroke onset were included in the current study. Patients were assigned to either the CP or HAL group. Outcome measures were collected at baseline, and at the 2nd (at 2–6 weeks), and 3rd (at 3–5 months) assessments. All patients underwent physical therapy until the 3rd assessment; patients in the HAL group underwent gait training using HAL until the 2nd assessment. Thirty-seven patients (19 from CP and 18 from HAL, median age = 69 years) completed the study. At the 2nd assessment, the total Functional Independence Measure (FIM) score was higher in the HAL group than in the CP group (90.1 vs. 79.0, p = 0.042). In conclusion, the FIM scale could be used to identify responsiveness to acute stroke rehabilitation using HAL.

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.