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.

Effectiveness of a Remote Monitoring-Based Home Training System for Preventing Frailty in Older Adults in Japan: A Preliminary Randomized Controlled Trial.

This study examined whether SUKUBARA®, a remotely managed training system that we developed, could improve skeletal muscle mass and muscle strength in community-dwelling older adults. SUKUBARA® is a composite exercise program that combines lower-load resistance training and balance exercises. Participants were instructed to exercise while watching individually assigned videos on YouTube, such that the research administrators could verify the viewing records of each participant. Fifteen participants (69 ± 4 years) were randomly assigned to the intervention (eight participants; the RT group) or the control group (seven participants; the CO group). The primary endpoint was a change in fat-free mass (FFM; kg), whereas the secondary endpoints included a change in knee extension strength (KES; Nm/kg). Correlation analyses were conducted to examine the relationship between FFM and KES. During the 12-week intervention period, significant differences were observed between the RT and CO groups in the changes in FFM (0.5 ± 0.5 vs. -0.1 ± 0.5) and KES (0.20 ± 0.22 vs. 0.02 ± 0.13), and significant positive correlations were found between the changes. Thus, SUKUBARA®-based interventions have the potential to improve muscle hypertrophy and enhance muscle strength among community-dwelling older adults. Thus, SUKUBARA® -based interventions show promise in improving muscle hypertrophy and enhance muscle strength among community-dwelling older adults. However, appropriately powered future research is needed to replicate these findings.

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.

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.

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.

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.

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.

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.

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.

Voluntary Ambulation by Upper Limb-Triggered HAL® in Patients with Complete Quadri/Paraplegia Due to Chronic Spinal Cord Injury.

Patients with complete paraplegia after spinal cord injury (SCI) are unable to stand or walk on their own. Standing exercise decreases the risk of decubitus ulcers, osteoporosis, and joint deformities in patients with SCI. Conventional gait training for complete paraplegia requires excessive upper limb usage for weight bearing and is difficult in cases of complete quadriplegia. The purpose of this study was to describe voluntary ambulation triggered by upper limb activity using the Hybrid Assistive Limb® (HAL) in patients with complete quadri/paraplegia after chronic SCI. Four patients (3 men, 1 woman) were enrolled in this study. The mean patient age ± standard deviation was 37.2 ± 17.8 (range, 20-67) years. Clinical evaluation before intervention revealed the following findings: case 1, neurological level C6, American Spinal Cord Injury Association impairment scale (AIS) grade B; case 2, T6, AIS A; case 3, T10 AIS A; and case 4, T11, AIS A. The HAL intervention consisted of 10 sessions. Each HAL session lasted 60-90 min. The HAL electrodes for hip and knee flexion-extension were placed on the anterior and posterior sides of the upper limbs contralaterally corresponding to each of the lower limbs. Surface electromyography (EMG) was used to evaluate muscle activity of the tensor fascia lata and quadriceps femoris (Quad) in synchronization with a Vicon motion capture system. The modified Ashworth scale (mAs) score was also evaluated before and after each session. All participants completed all 10 sessions. Cases 1, 2, and 3 demonstrated significant decreases in mAs score after the sessions compared to pre-session measurements. In all cases, EMG before the intervention showed no apparent activation in either Quad. However, gait phase dependent activity of the lower limb muscles was seen during voluntarily triggered ambulation driven by upper limb muscle activities. In cases 3 and 4, active contraction in both Quads was observed after intervention. These findings suggest that upper-limb-triggered HAL ambulation is a safe and feasible option for rehabilitation in patients with complete quadri/paraplegia caused by chronic SCI.