Gait ability required to achieve therapeutic effect in gait and balance function with the voluntary driven exoskeleton in patients with chronic spinal cord injury: a clinical study

Okawara, Hiroki; Sawada, Tomio; Matsubayashi, Kohei; Sugai, Keiko; Tsuji, Osahiko; Nagoshi, Narihito; Matsumoto, Morio; Nakamura, Masaya

doi:10.1038/s41393-019-0403-0

Cited by 16 publications

(21 citation statements)

References 28 publications

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“…Preliminary studies have also shown that HAL-HN01 is a useful medical device for improving the motor function. Future RCTs will be needed to prove efficacy and safety in other diseases, such as cerebrovascular disease [ 48 – 50 ], spinal cord injury [ 51 , 52 ], multiple sclerosis, Parkinson disease, spinocerebellar degeneration, and Guillain–Barre syndrome. Although the present RCT results are limited to only neuromuscular diseases, this study opens the possibility of applying cybernic treatment to other diseases.…”

Section: Discussionmentioning

confidence: 99%

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)

Nakajima

Sankai

Takata

et al. 2021

Orphanet J Rare Dis

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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

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Section: Discussionmentioning

confidence: 99%

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)

Nakajima

Sankai

Takata

et al. 2021

Orphanet J Rare Dis

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“…To date, various studies have reported training using the robotic exoskeleton, but clear training standards and methods are not yet clear. While some studies have reported that at least 20 sessions or more training is required for subjects to independently use the robotic exoskeleton [9,14], some studies have suggested that independent walking using the robotic exoskeleton is possible even with 6-9 sessions of training [10,13]. Bass et al [12] suggested that it is required to identify a training period and method that could minimize the load on the upper extremities and shoulders in order to properly perform gait and functional movements using the robotic exoskeleton and to prevent musculoskeletal damage.…”

Section: Discussionmentioning

confidence: 99%

“…Before participating in training, anthropometric measurements of the participants were obtained. The locomotor training program with the robotic exoskeleton consisted of a total of 20 sessions of 50 min per session, three times a week [9,14]. During this period, participants were trained under the management of certified therapists, and the training goals and detailed training information for each session are shown in Appendix A.…”

Section: Training Proceduresmentioning

confidence: 99%

“…In the past 10 years of research on gait training using various robotic exoskeletons for SCI patients, it has been reported that independent gait is possible with 8-20 training sessions [9][10][11][12][13][14]. As such, the robotic exoskeleton could enhance the walking ability of SCI patients, in particular, the possibility of independent activity through the robot exoskeleton in patients with complete sensorimotor SCI depends on whether it is possible to perform movements with only the upper extremity.…”

Section: Introductionmentioning

confidence: 99%

“…Since SCI patients have a different level of body function according to the type and level of injury, the training period required to use the robotic exoskeleton is different. Therefore, a standardized training protocol for the use of exoskeleton walking robots was inconsistent until the present [9][10][11][12][13][14]. In order to develop a standardized training protocol for SCI, it is preferentially necessary to establish a standard of a common minimum training period.…”

Section: Introductionmentioning

confidence: 99%

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Preliminary Assessment of Muscle Activity and Muscle Characteristics during Training with Powered Robotic Exoskeleton: A Repeated-Measures Study

2021

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A variety of robotic exoskeletons have been developed for patients with spinal cord injuries. However, the optimal training method and period for using a robotic exoskeleton have been uncertain until now. The purpose of this study is to determine the minimum training period for using a robotic exoskeleton with minimal muscle activity by investigating the changes in muscle activity and muscle characteristics of healthy adults during robotic exoskeleton training. A total of 16 people participated in the study. The robotic exoskeleton locomotion training consisted of three 50-min sessions a week for 7 weeks. The assessment consisted of sitting, standing, wide standing, sit-to-stand, and stand-to-sit where muscle activity and muscle characteristics were measured during each motion. All measurements were performed in the first session and every five sessions. Participants showed decreased muscle activity up to 10 sessions of training in the standing position, and 15 sessions in sit-to-stand and stand-to-sit motions. Upper extremity muscles showed decreased muscle activity, tone, stiffness, and logarithmic decrement up to the 15th session. The study results show that at least 15 training sessions are required to use the robotic exoskeleton with minimal load on the musculoskeletal system, and longer training is required for patients with spinal cord injury.

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Wearable powered exoskeletons for gait training in tetraplegia: a systematic review on feasibility, safety and potential health benefits

et al. 2022

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Gait ability required to achieve therapeutic effect in gait and balance function with the voluntary driven exoskeleton in patients with chronic spinal cord injury: a clinical study

Cited by 16 publications

References 28 publications

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)

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)

Preliminary Assessment of Muscle Activity and Muscle Characteristics during Training with Powered Robotic Exoskeleton: A Repeated-Measures Study

Wearable powered exoskeletons for gait training in tetraplegia: a systematic review on feasibility, safety and potential health benefits

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