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.

Rehabilitation of Acute Vs. Chronic Patients With Spinal Cord Injury With a Neurologically Controlled Hybrid Assistive Limb Exoskeleton: Is There a Difference in Outcome?

This study aimed to assess the outcome of acute and chronic participants with spinal cord injury (SCI) after 12 weeks of bodyweight supported treadmill training (BWSTT) with a hybrid assistive limb exoskeleton (HAL). Acute participants were defined as ≤12 months between SCI and training, chronic participants >12 months between SCI and training. We assessed whether HAL-assisted BWSTT is advantageous for acute and chronic participants and if length of time post injury impacts the outcome of HAL-assisted BWSTT. As the primary outcome, we assessed the time needed for the 10 meter walk test (10MWT). Hundred and twenty-one individuals participated in a 12-week HAL-assisted BWSTT five times a week. We regularly conducted a 10MWT, a 6 minute walk test (6MWT), and assessed the walking index for spinal cord injury (WISCI II) and lower extremity motor score (LEMS) to evaluate the gait performance without the exoskeleton. Distance and time were recorded by the treadmill while the participant was walking with the exoskeleton. All participants benefit from the 12-week HAL-assisted BWSTT. A significant difference between acute and chronic participants' outcomes was found in 6MWT, LEMS, and WISCI II, though not in 10MWT. Although chronic participants improved significantly lesser than acute participants, they did improve their outcome significantly compared to the beginning. Hybrid assistive limb-assisted BWSTT in the rehabilitation of patients with SCI is advantageous for both acute and chronic patients. We could not define a time related cut-off threshold following SCI for effectiveness of HAL-assisted BWSTT.

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.

Improved Physiological Gait in Acute and Chronic SCI Patients After Training With Wearable Cyborg Hybrid Assistive Limb

In recent years robotic devices became part of rehabilitation offers for patients suffering from Spinal Cord Injury (SCI) and other diseases. Most scientific publications about such devices focus on functional outcome. The aim of this study was to verify whether an improvement in physiological gait can be demonstrated in addition to the functional parameters after treatment with neurological controlled HAL® Robot Suit. Fifteen subjects with acute (<12 months since injury, n = 5) or chronic (>12 months since injury, n = 10) incomplete paraplegia (AIS B, n = 0/AIS C, n = 2/AIS D, n = 8) or complete paraplegia (AIS A, n = 5) with zones of partial preservation participated. Subjects underwent a body weight supported treadmill training for five times a week over 12 weeks using HAL®. At baseline and at the end of the study a gait analysis was performed and additional functional parameters such as 10-Meter-Walk-Test, Timed-Up-and-Go-Test, 6-Minutes-Walk-Test, and WISCI II score were collected. Results were evaluated for whole group and individually for acute and chronic subgroups. All functional parameters improved. Differences were also found in physiological parameters such as phases of gait cycle and accompanied by significant improvement in all spatiotemporal and gait phase parameters. The presented study shows signs that an improvement in physiological gait can be achieved in addition to improved functional parameters in patients with SCI after completing 12-week training with HAL®.Trial Registration: DRKS, DRKS00020805. Registered 12 February 2020—Retrospectively registered, https://www.drks.de/DRKS00020805.

Exercise Therapy Using the Lumbar-Type Hybrid Assistive Limb Ameliorates Locomotive Function after Lumbar Fusion Surgery in an Elderly Patient

The number of elderly people who undergo lumbar fusion surgery (LFS) has been increasing. Postoperative rehabilitation for them can be problematic due to lumbar stiffness. This is the first case report describing exercise therapy using the lumbar-type hybrid assistive limb (HAL) after multiple LFS in an elderly patient. An 83-year-old man underwent LFS at L4-S1. Additional fusion surgery at L2-3 for adjacent segment disease was performed 2 years after the primary surgery. Although the patient’s leg pain declined, he had severe locomotive dysfunction at 3 months after his final surgery. He started exercise therapy using the lumbar-type HAL including sit-to-stand training and squat training 4 months after his final surgery. He performed 3 sets of 20 sit-to-stand and 20 squat repetitions with adequate rests in between sets. The HAL training was safely conducted every day for 12 weeks without adverse event. Timed up and go test (TUG), 1-minute sit to stand test (1MSTS), one-leg stand test (OLST), and Berg balance scale (BBS) were assessed as locomotive function measurement. Before HAL therapy, TUG, 1MSTS, OLST, and BBS were 18.1 sec, 20 times, less than 1 sec, and 47, respectively. He could not walk without assistance. After the exercise therapy with the lumbar-type HAL, his locomotive function dramatically improved. TUG, 1MSTS, OLST, and BBS were 12.2 sec, 25 times, 3.9 sec, and 52, respectively. Moreover, the patient could walk 60 meters continuously without assistance. The unique characteristics of the lumbar-type HAL to prevent the lumbar overload and assist the voluntary hip joint motion during exercise therapy may be effective for this patient with lumbar stiffness after LFS. Sit-to-stand training and squat training using the lumbar-type HAL are promising options to improve locomotive function in elderly patients after LFS.

Cybernic treatment with wearable cyborg Hybrid Assistive Limb (HAL) improves ambulatory function in patients with slowly progressive rare neuromuscular diseases: a multicentre, randomised, controlled crossover trial for efficacy and safety (NCY-3001)

Background Rare neuromuscular diseases such as spinal muscular atrophy, spinal bulbar muscular atrophy, muscular dystrophy, Charcot-Marie-Tooth disease, distal myopathy, sporadic inclusion body myositis, congenital myopathy, and amyotrophic lateral sclerosis lead to incurable amyotrophy and consequent loss of ambulation. Thus far, no therapeutic approaches have been successful in recovering the ambulatory ability. Thus, the aim of this trial was to evaluate the efficacy and safety of cybernic treatment with a wearable cyborg Hybrid Assistive Limb (HAL, Lower Limb Type) in improving the ambulatory function in those patients. Results We conducted an open-label, randomised, controlled crossover trial to test HAL at nine hospitals between March 6, 2013 and August 8, 2014. Eligible patients were older than 18 years and had a diagnosis of neuromuscular disease as specified above. They were unable to walk for 10 m independently and had neither respiratory failure nor rapid deterioration in gait. The primary endpoint was the distance passed during a two-minute walk test (2MWT). The secondary endpoints were walking speed, cadence, and step length during the 10-m walk test (10MWT), muscle strength by manual muscle testing (MMT), and a series of functional measures. Adverse events and failures/problems/errors with HAL were also evaluated. Thirty patients were randomly assigned to groups A or B, with each group of 15 receiving both treatments in a crossover design. The efficacy of a 40-min walking program performed nine times was compared between HAL plus a hoist and a hoist only. The final analysis included 13 and 11 patients in groups A and B, respectively. Cybernic treatment with HAL resulted in a 10.066% significantly improved distance in 2MWT (95% confidence interval, 0.667–19.464; p = 0.0369) compared with the hoist only treatment. Among the secondary endpoints, the total scores of MMT and cadence at 10MWT were the only ones that showed significant improvement. The only adverse effects were slight to mild myalgia, back pain, and contact skin troubles, which were easily remedied. Conclusions HAL is a new treatment device for walking exercise, proven to be more effective than the conventional method in patients with incurable neuromuscular diseases. Trial registration: JMACTR, JMA-IIA00156