Single-Joint Type Hybrid Assistive Limb for Knee Training in the Acute Postoperative Phase After Opening Wedge High Tibial Osteotomy: A Feasibility and Safety Trial.

BACKGROUND AND OBJECTIVE: Opening wedge high tibial osteotomy (OWHTO) influences the knee extensor mechanism, the range of passive motion of knee extension and persistent quadriceps, and anterior knee pain and weakness. Rehabilitation should focus on quadriceps strength and improving joint mobility. The single-joint hybrid assistive limb device (HAL-SJ) is a wearable exoskeleton cyborg. In this study, we investigated the feasibility and safety of HAL-SJ training after the early postoperative period following OWHTO and whether the use of this device can improve functional outcomes, including knee muscle extensor strength and knee extension range of motion without knee pain. METHODS: Patients who had been diagnosed with knee osteoarthritis and had undergone OWHTO were assessed for eligibility in this prospective trial conducted at our institution between June 2015 and November 2020. The participants were split into two groups, i.e., 10 patients in the hybrid assistive limb (HAL) group and eight patients in the control group. We initiated HAL-SJ therapy on postoperative day 8 and continued it until the patient's discharge. During the hospitalization period, patients engaged in HAL-SJ-assisted knee extension exercises. This exercise routine encompassed five sets, each comprising 10 repetitions, and was conducted twice a week. We conducted assessments aimed at detecting any potential adverse events that could be linked to HAL training. Assessment of the knee extension angle via the visual analog scale (VAS) and strength assessments using a hand-held dynamometer (HHD) were conducted. To compare clinical outcomes before and after OWHTO, knee extension angle, the VAS, HHD, Japanese Orthopaedics Association (JOA) score, and the Japanese Knee Osteoarthritis Measure (JKOM) were assessed at four distinct time points. RESULTS: No adverse events were observed during the study. The assessment of clinical outcomes before and after OWHTO demonstrated a gradual improvement in outcomes. CONCLUSION: The single-joint hybrid assistive limb device in patients who underwent OWHTO appears to be potentially safe. It contributed to enhanced muscle activity efficiency by reducing knee pain and improving knee extension angles in the early postoperative phase.

Biofeedback training using a hybrid assistive limb after brachial plexus injury.

This study investigated the use of an upper limb hybrid assistive limb for elbow flexion biofeedback training in recovery from brachial plexus injury in both the postoperative and chronic phases. No adverse events were observed in any patient.Level of evidence: IV.

Muscle Strength and Efficiency of Muscle Activities Recovery Using Single-Joint Type Hybrid Assistive Limb in Knee Rehabilitation after Anterior Cruciate Ligament Reconstruction.

Decreased muscle strength often occurs after anterior cruciate ligament (ACL) reconstruction; this can include muscle atrophy, neuromuscular dysfunction, and reduced force generation efficiency. Hybrid assistive limb (HAL) technology, which integrates an interactive biofeedback system connecting the musculoskeletal system to the brain and spinal motor nerves, offers a potential intervention. Our study, conducted from March 2018 to August 2023 using knee HAL single-joint technology, was a prospective non-randomized controlled trial involving 27 patients who had undergone arthroscopic ACL reconstruction. They were split into two groups: HAL (18 patients) and control (nine patients). Beginning 18 weeks after their surgery, the HAL group participated in three weekly sessions of knee HAL-assisted exercises. Both the HAL and control groups underwent isokinetic muscle strength tests at postoperative weeks 17 and 21. Testing utilized an isokinetic dynamometer at 60°/s, 180°/s, and 300°/s. The Limb Symmetry Index (LSI) was employed to measure side-to-side differences. The HAL group showed significant LSI improvements in peak extension torque across all testing velocities and for peak flexion torque at 60°/s and 300°/s. The rate of change in LSI for peak flexion torque at 300°/s was significantly higher post-measurements (p = 0.036; effect size = 1.089). The change rate for LSI in peak extension torque at 300°/s and all peak flexion torques showed medium to large effect sizes in Cohen's d. In conclusion, knee HAL single-joint training positively influenced muscle strength recovery and efficiency. The HAL training group exhibited superior muscle strength at various isokinetic testing velocities compared to the control group.

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.

Feasibility and Efficacy of the Newly Developed Robotic Hybrid Assistive Limb Shoulder Exercises in Patients with C5 Palsy during the Acute Postoperative Phase.

Background and Objectives: Although postoperative C5 palsy is a frequent complication of cervical spine surgery, no effective therapeutic rehabilitation approach has been established for postoperative C5 palsy. The purpose of this study was to find evidence confirming the effectiveness and feasibility of robotic Hybrid Assistive Limb (HAL) shoulder exercises for C5 palsy. Materials and Methods: In this before-after, uncontrolled case series clinical study, we performed a mean of 11.7 shoulder training sessions using a shoulder HAL immediately after the onset of C5 palsy in seven shoulders of six patients who developed postoperative C5 palsy and had difficulty raising their shoulder during the acute postoperative phase of cervical spine surgery. Shoulder HAL training was introduced as early as possible after evaluating the general condition of all inpatients who developed C5 palsy. Patients underwent shoulder abduction training using shoulder HAL on an inpatient and outpatient basis at 2-week or 1-month intervals. Adverse events associated with shoulder HAL training were investigated. The shoulder abduction angle and power without the shoulder HAL were evaluated before shoulder HAL usage, at every subsequent session, and upon completion of all sessions. Results: Severe adverse events due to shoulder HAL training were not reported. After completion of all shoulder HAL sessions, all patients showed improved shoulder elevation, while shoulder abduction angle and power improved over time. Conclusions: Shoulder elevation training with HAL in patients in the acute stage of postoperative C5 palsy has the potential to demonstrate improvement in shoulder joint function with a low risk of developing severe adverse events.

New Neuromuscular Training for Peripheral Nerve Disorders Using an Ankle Joint Hybrid Assistive Limb: A Case Series.

Peripheral nerve disorder of the lower extremities causes drop foot and disturbs the daily living activities of patients. The ankle joint hybrid assistive limb (HAL) provides voluntary ankle joint training using surface bioelectrical signals from the muscles of the lower extremities. We investigated the neurological effects of ankle joint HAL training in three patients. Sensory nerve action potentials (SNAPs) and compound muscle action potentials (CMAPs) were analyzed for the peroneal and tibial nerves prior to the first ankle joint HAL training session. Integrated surface electromyography EMG signals were recorded before and after the HAL training sessions to evaluate the effects of training for neuromuscular disorders. The patients were hospitalized to receive rehabilitation with HAL training for 2 weeks. The HAL training was performed daily with two 60 min sessions. All cases demonstrated severe neuromuscular impairment according to the result of the CMAP. All integrated EMG measurements of antagonistic muscle activities decreased after the ankle joint HAL training. The manual muscle testing (MMT) scores of each muscle were slightly increased after the HAL intervention for Case 2(tibialis anterior, from 2 to 2+; gastrocnemius muscles, from 2- to 2; extensor digitorum longus, and extensor hallucis longus, from 1 to 3). The MMT scores were also slightly increased except for gastrocnemius muscle for Case 3 (tibialis anterior, extensor digitorum longus, and extensor hallucis longus, from 2- to 2). These two patients demonstrated voluntary muscle contractions and nerve signals in the CMAP before the HAL training. Even though the amplitude of CMAPs was low, the HAL training may provide voluntary ankle joint movements by reducing the antagonistic muscle contraction via computer processing. The HAL training may enhance muscle movement and coordination through motor learning feedback.

Robotic rehabilitation therapy using Hybrid Assistive Limb (HAL) for patients with spinal cord lesions: a narrative review.

Background: The Hybrid Assistive Limb (HAL) is a rehabilitation device that utilizes the "interactive biofeedback" hypothesis to facilitate the motion of the device according to the user's motion intention and appropriate sensory input evoked by HAL-supported motion. HAL has been studied extensively for its potential to promote walking function in patients with spinal cord lesions, including spinal cord injury. Methods: We performed a narrative review of HAL rehabilitation for spinal cord lesions. Results: Several reports have shown the effectiveness of HAL rehabilitation in the recovery of walking ability in patients with gait disturbance caused by compressive myelopathy. Clinical studies have also demonstrated potential mechanisms of action leading to clinical findings, including normalization of cortical excitability, improvement of muscle synergy, attenuation of difficulties in voluntarily initiating joint movement, and gait coordination changes. Conclusions: However, further investigation with more sophisticated study designs is necessary to prove the true efficacy of HAL walking rehabilitation. HAL remains one of the most promising rehabilitation devices for promoting walking function in patients with spinal cord lesions.

Shoulder Joint Hybrid Assistive Limb Treatment for Chronic Stroke Patients with Upper Limb Dysfunction.

Upper extremity dysfunction after stroke affects quality of life. Focusing on the shoulder joint, we investigated the safety and effectiveness of rehabilitation using a shoulder joint hybrid assistive limb (HAL). Eight patients with chronic stroke and upper extremity functional disability were enrolled and used a shoulder joint HAL, which assisted shoulder movement based on the user's intention, through myoelectric activation of the shoulder flexor. Ten training sessions of 30-40 min each were performed to assist voluntary movement of upper limb elevation on the affected side through triggering the deltoid muscle. All patients completed the interventions without shoulder pain. Surface electromyography evaluation indicated post-intervention improvement in coordinated movement of the affected upper extremity. Significant improvements in voluntary and passive shoulder joint range of motion were obtained after the intervention, suggesting improvement in shoulder muscle strength. A significant decrease in the modified Ashworth scale and improvements in functional scores in the upper limb were also observed. Along with safe use for our study patients, the shoulder HAL provided appropriate motor learning benefits. Improvements in shoulder joint function and whole upper limb function were observed, suggesting that HAL could be an optimal treatment method.

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.

Alteration of muscle activity during voluntary rehabilitation training with single-joint Hybrid Assistive Limb (HAL) in patients with shoulder elevation dysfunction from cervical origin.

Shoulder elevation, defined here as arm raising, being essential for activities of daily living, dysfunctions represent a substantial burden in patients' lives. Owing to the complexity of the shoulder joint, the tightly coordinated muscular activity is a fundamental component, and neuromuscular impairments have devastating effects. A single-joint shoulder type version of the Hybrid Assistive Limb (HAL) allowing motion assistance based on the intention of the user via myoelectric activation has recently been developed, and its safety was demonstrated for shoulder rehabilitation. Yet, little is known about the physiological effects of the device. This study aims to monitor the changes in muscle activity and motion during shoulder HAL rehabilitation in several patients suffering from shoulder elevation dysfunction from cervical radicular origin. 8 patients (6 males, 2 females, mean age 62.4 ± 9.3 years old) with weakness of the deltoid muscle resulting from a damage to the C5 nerve root underwent HAL-assisted rehabilitation. We combined surface electromyography and three-dimensional motion capture to record muscular activity and kinematics. All participants showed functional recovery, with improvements in their Manual Muscle Testing (MMT) scores and range of motion (ROM). During training, HAL decreased the activity of deltoid and trapezius, significantly more for the latter, as well as the coactivation of both muscles. We also report a reduction of the characteristic shrugging compensatory motion which is an obstacle to functional recovery. This reduction was notably demonstrated by a stronger reliance on the deltoid rather than the trapezius, indicating a muscle coordination tending toward a pattern similar to healthy individuals. Altogether, the results of the evaluation of motion and muscular changes hint toward a functional recovery in acute, and chronic shoulder impairments from cervical radicular origin following shoulder HAL rehabilitation training and provide information on the physiological effect of the device.

Single-joint Hybrid Assistive Limb in Knee Rehabilitation after ACL Reconstruction: An Open-label Feasibility and Safety Trial.

Objectives: To achieve better outcomes, neuromuscular and biomechanical factors should be considered in rehabilitation after anterior cruciate ligament reconstruction. In this study, we investigated the feasibility and safety of a wearable exoskeleton robot suit [known as the single-joint hybrid assistive limb (HAL-SJ)] and whether knee training using this device could improve functional outcomes after anterior cruciate ligament reconstruction. Methods: HAL-SJ-assisted knee extension and flexion exercises were commenced in 11 patients 18 weeks after reconstruction; exercises were performed once a week for three weeks at a frequency of five sets of ten repetitions. Patients were monitored for HAL-SJ-related adverse events. Physical evaluations were conducted before and after HAL-SJ training. Surface electromyography of the quadriceps and hamstring muscles was performed in 4 of the 11 patients during each session and the muscle co-contraction index was calculated. Results: The peak muscle torque was higher at all velocities after HAL-SJ training. The active range of motion significantly increased in both extension and flexion, and the range of motion in passive flexion significantly increased. The Tegner Activity Scale and Lysholm Knee Questionnaire scores also significantly increased after knee HAL training. The muscle co-contraction index during extension tended to be lower after HAL-SJ training. No adverse events were observed. Conclusions: The findings of this study indicate the feasibility and safety of HAL-SJ training as a neuromuscular rehabilitation tool after anterior cruciate ligament reconstruction. The knee HAL-SJ training may have contributed to these results from a neurophysiological perspective by lowering the co-contraction of knee muscles, which would correct impairment of the antagonistic or synergistic muscles.

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.

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.

Functional magnetic resonance imaging of brain activity during hybrid assistive limb intervention in a chronic spinal cord injury patient with C4 quadriplegia.

Hybrid assistive limb (HAL) is a wearable robot, which has recently been used for the treatment of patients with movement disorders including spinal cord injury (SCI). Although several studies have indicated the effectiveness of HAL for SCI patients, changes in brain activity during the HAL intervention have not yet been fully characterized. A 19-year-old man with a chronic SCI resulting in complete C4 quadriplegia underwent five weeks of HAL training for a total of ten sessions. We evaluated his brain activity using task-induced functional MRI (fMRI) after the fourth, sixth and tenth HAL sessions. We also assessed the spasticity of this patient using the modified Ashworth scale (mAs). As controls for the task-induced fMRI, we examined the brain activity in two healthy subjects. The fMRI findings indicated an increased response to a motor imagery task in the patient's cerebral cortex compared to controls. In addition, the activation pattern in his cortex changed during the five weeks of HAL intervention. We observed increased cerebral lateralization in his primary motor cortex. We also found that the laterality index calculated for the precentral gyrus had a significant negative correlation with the total mAs score over the course of the HAL treatment. Our results indicate that the cerebral cortex of the present SCI patient was hyperactive during the imagery task, and the cortical activation was reduced with progression of the HAL treatment.

Immediate effects of hybrid assistive limb gait training on lower limb function in a chronic myelopathy patient with postoperative late neurological deterioration.

OBJECTIVE: The Hybrid Assistive Limb (HAL) has recently been used to treat movement disorders. Although studies have shown its effectiveness for chronic myelopathy, the immediate effects of HAL gait training on lower limb function have not been clarified. We conducted HAL gait training and examined its immediate effects on a 69-year-old man with re-deterioration of myelopathy in the chronic phase after surgery for compression myelopathy. The HAL intervention was performed every 4 weeks for 10 total sessions. Immediately before and after each session, we analyzed the patient's walking ability using the 10-m walk test. In the 4th HAL session, the gastrocnemius muscle activity was measured bilaterally using a synchronized motion capture-electromyogram system. RESULTS: The training effects became steady after the 2nd session. In sessions 2-10, the step length increased from 0.56 to 0.63 m (mean: 0.031 m) immediately after HAL training. The motion capture-electromyogram analyses showed that considerable amounts of gastrocnemius muscle activity were detected during the stance and swing phases before HAL training. During and immediately after HAL training, gastrocnemius activity during the swing phase was diminished. HAL gait training has an immediate effect for inducing a normal gait pattern with less spasticity in those with chronic myelopathy.

Electromyographic examination of knee training using a hybrid assistive limb after anterior cruciate ligament reconstruction: A case report.

Muscle co-contraction can result in higher joint contact forces, compromising knee joint mobility for stability, thus leading to impaired lower extremity neuromuscular control, delayed return to sports, and increased incidence of secondary anterior cruciate ligament (ACL) injury post-ACL reconstruction. Hybrid assistive limb (HAL) training has the potential to correct impairment of antagonistic or synergistic muscle movement of the knee joint through bioelectric signal feedback from muscle signals with computer processing. We considered that HAL training would contribute to improve peak muscle torque through coordinating or decreasing higher levels of muscle co-contractions and reducing differences between hamstring and quadriceps muscle activity on electromyography (EMG). While playing handball, a 20-year-old female injured her ACL upon landing on one leg. Two months post-injury, she underwent arthroscopic, anatomic single-bundle ACL reconstruction with a semitendinosus tendon autograft. At a 4-month follow-up, she underwent knee HAL training, which was performed once a week for three sessions. EMG data were collected during the evaluations of pre- and post-HAL training. The average muscle amplitude was used to calculate the difference between vastus lateralis (VL) and semitendinosus (ST) muscles, and the muscle co-contraction index (CCI). The CCI reflects the simultaneous activation of antagonistic muscles, which is determined for knee extensor-flexor muscle pairs. Post-knee HAL training, the CCI of the lateral hamstring and quadriceps muscles during extension was lower than that during pre-HAL training in all sessions. However, no differences were found in the CCI for the medial hamstring and quadriceps muscles during extension and flexion pre- and post-knee HAL training. For post-knee HAL training, the difference between VL and ST EMG data during a closed-chain squat was lower than that during pre-HAL training in all sessions. Knee HAL training contributed to improved peak muscle torque through coordinating or decreasing higher levels of muscle co-contractions, and it reduced differences between hamstring and quadriceps muscle activity in the ACL reconstructed leg as depicted by EMG.

Robotic Shoulder Rehabilitation With the Hybrid Assistive Limb in a Patient With Delayed Recovery After Postoperative C5 Palsy: A Case Report.

C5 palsy is a serious complication that may occur after cervical spine surgery; however, standard procedures for shoulder rehabilitation for patients with postoperative C5 palsy have not yet been established. We used a wearable robot suit Hybrid Assistive Limb (HAL) in a patient with delayed recovery after postoperative C5 palsy and conducted shoulder abduction training with the HAL. A 62-year-old man presented with weakness in his left deltoid muscle 2 days after cervical spine surgery. He experienced great difficulty in elevating his left arm and was diagnosed with postoperative C5 palsy. Seven months after surgery, shoulder abduction training with a HAL was initiated. In total, 23 sessions of shoulder HAL rehabilitation were conducted until 26 months after surgery. His shoulder abduction angle and power improved at every HAL session, and he was able to fully elevate his arm without any compensatory movement after the 23rd session, suggesting that the HAL is a useful tool for shoulder rehabilitation in patients with postoperative C5 palsy. We employed shoulder HAL training for a patient with delayed recovery from postoperative C5 palsy and achieved complete restoration of shoulder function. We believe that the HAL-based training corrected the erroneous motion pattern of his paralyzed shoulder and promoted errorless motor learning for recovery. Our collective experience suggests that shoulder HAL training could be an effective therapeutic tool for patients with postoperative C5 palsy.

Efficacy and Safety Study of Wearable Cyborg HAL (Hybrid Assistive Limb) in Hemiplegic Patients With Acute Stroke (EARLY GAIT Study): Protocols for a Randomized Controlled Trial.

We hypothesized that gait treatment with a wearable cyborg Hybrid Assistive Limb (HAL) would improve the walking ability of patients with hemiparesis after stroke. This study aims to evaluate the efficacy and safety of gait treatment using HAL versus conventional gait training (CGT) in hemiplegic patients with acute stroke and establish a protocol for doctor-initiated clinical trials for acute stroke. We will enroll patients with acute stroke at the University of Tsukuba Hospital. This study is a single-center, randomized, parallel-group, controlled trial (HAL group, n = 20; control group, n = 20) that will include three phases: (1) pre-observation phase (patient enrollment, baseline assessment, and randomization); (2) treatment phase (nine sessions, twice or thrice per week over 3-4 weeks; the HAL and control groups will perform gait treatment using HAL or CGT, respectively, and finally (3) post-treatment evaluation phase. The Functional Ambulation Category score will be the primary outcome measure, and the following secondary outcome measures will be assessed: Mini-Mental State Examination, Brunnstrom recovery stage of lower limbs, Fugl-Meyer assessment of lower limbs, 6-min walking distance, comfortable gait speed, step length, cadence, Barthel Index, Functional Independence Measure, gait posture, motion analysis (muscle activity), amount of activity (evaluated using an activity meter), stroke-specific QOL, and modified Rankin Scale score. The baseline assessment, post-treatment evaluation, and follow-up assessment will evaluate the overall outcome measures; for other evaluations, physical function evaluation centered on walking will be performed exclusively, excluding ADL and QOL scores. This study is a randomized controlled trial that aims to clarify the efficacy and safety of gait treatment using HAL compared with CGT in hemiplegic patients with acute stroke. In addition, we aim to establish a protocol for doctor-initiated clinical trials for acute stroke based on the study results. If our results demonstrate the effectiveness of the proposed treatment regarding outcomes of patients with hemiplegic acute stroke, this study will promote the treatment of these patients using the HAL system as an effective tool in future stroke rehabilitation programs. The study protocol was registered with the Japan Registry of Clinical Trials on October 14, 2020 (jRCTs032200151).

Hybrid Assistive Limb Functional Treatment for a Patient with Chronic Incomplete Cervical Spinal Cord Injury.

INTRODUCTION: The hybrid assistive limb (HAL) is a wearable exoskeleton cyborg that assists walking and lower limb movements via real-time actuator control by detecting the wearer's bioelectric signals on the surface of their skin. PURPOSE: The purpose of this study was to report the improvement in walking ability following HAL gait training in a patient with tetraplegia after incomplete cervical spinal cord injury (SCI). PATIENT AND METHODS: A 47-year-old man with traumatic cervical SCI for six months after fall had incomplete tetraplegic SCI grade C as classified according to the American Spinal Cord Injury Association impairment scale and was unable to walk in conventional rehabilitation. RESULTS: The HAL gait training was received 2 or 3 times per week for 13 sessions. Improvement was observed in gait speed (baseline: 0.12; after training: 0.45 m/sec), step length (baseline: 0.30; after training: 0.45 m), and cadence (baseline: 23.1; after training: 59.6 steps/min) based on a 10-meter walking test; International Standards for Neurological and functional Classification of Spinal Cord Injury (ISNCSCI) motor score (baseline: 59; after training: 76); and walking index for spinal cord injury (WISCI) II score (baseline: 1; after training: 6). CONCLUSION: We report the recovery of walking ability in a patient with chronic severe incomplete tetraplegic SCI following the HAL training.