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      Effects of Long-term Hybrid Assistive Limb Use on Gait in Patients with Amyotrophic Lateral Sclerosis

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          Abstract

          Objective

          To assess the long-term effects of hybrid assistive limb (HAL) treatment on gait in patients with amyotrophic lateral sclerosis (ALS).

          Methods

          Three courses of treatment with HAL were administered to three women with ALS. Each course had a four- to five-week duration, during which the treatment was performed nine times, with a rest period of at least two months between each course. Gait ability (2-minutes-walk and 10-m-walk tests), ALS Functional Rating Scale-Revised, and respiratory function tests were performed before and after each treatment course.

          Patients

          Patients diagnosed with ALS, according to the updated Awaji criteria, by board-certified neurologists in the Department of Neurology and Department of Rehabilitation Medicine, Toho University Omori Faculty of Medicine between January and December 2019 were recruited.

          Results

          The average time from the start to the end of the 3 courses was 319.7±33.7 days. A multiple regression analysis was performed for the 2-minutes-walk and 10-m-walk tests, using the baseline value, each participant's ID, and time point as covariates. Changes after each course were considered outcomes. Following the 3 treatment courses, the 2-minutes walk distance improved by 16.61 m (95% confidence interval, -9.33-42.54) compared with the baseline value, but this improvement was not statistically significant (p=0.21). However, cadence significantly improved by 1.30 steps (95% confidence interval, 0.17-2.42; p=0.02).

          Conclusion

          Long-term, repetitive HAL treatments may help patients with ALS maintain their gait.

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          Most cited references28

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          Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.

          (2017)
          In a previous phase 3 study in patients with amyotrophic lateral sclerosis (ALS), edaravone did not show a significant difference in the Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo. Post-hoc analysis of these data revealed that patients in an early stage with definite or probable diagnosis of ALS, defined by the revised El Escorial criteria, who met a select set of inclusion criteria showed a greater magnitude of effect than did the full study population. We aimed to substantiate this post-hoc result and assess safety and efficacy of edaravone in a phase 3 trial that focused on patients with early stage ALS who met the post-hoc analysis inclusion criteria.
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            Pilot study of locomotion improvement using hybrid assistive limb in chronic stroke patients

            Background Locomotor training using robots is increasingly being used for rehabilitation to reduce manpower and the heavy burden on therapists, and the effectiveness of such techniques has been investigated. The robot suit Hybrid Assistive Limb (HAL) has been developed to rehabilitate or support motor function in people with disabilities. The HAL provides motion support that is tailored to the wearer’s voluntary drive. We performed a pilot clinical trial to investigate the feasibility of locomotor training using the HAL in chronic stroke patients, and to examine differences between two functional ambulation subgroups. Methods Sixteen stroke patients in the chronic stage participated in this study. All patients were trained with the HAL over 16 sessions (20–30 min/day within 2 days/week). Primary outcomes were walking speed, cadence, and number of steps recorded during a 10-meter walk test (10MWT). Berg balance scale (BBS) and timed up and go (TUG) were also measured. All outcome measures were evaluated without wearing HAL assistance before and after the intervention in all patients as well as in the dependent ambulatory and independent ambulatory subgroups. Results All participants completed the intervention with no adverse events. Gait speed, cadence, number of steps during the 10MWT, and BBS increased significantly from 0.41 m/s to 0.45 m/s (P = 0.031), from 68.6 steps/min to 72.0 steps/min (P = 0.020), from 37.5 steps to 33.1 steps (P = 0.017), and from 40.6 to 45.4 (P = 0.004) respectively. The TUG test score improved, although this difference was not statistically significant. The findings in the dependent ambulatory subgroup primarily contributed to the significant differences observed in the group as a whole. Conclusions This pilot study showed that locomotor training using the HAL is feasible for chronic stroke patients. Randomized controlled trials are now required to demonstrate the effectiveness of HAL-based rehabilitation over conventional therapies. Trial registration UMIN000002969
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              The value of muscle exercise in patients with amyotrophic lateral sclerosis.

              The role of physical activity for patients with amyotrophic lateral sclerosis (ALS) is controversial. Twenty-five ALS patients were randomized to receive a moderate daily exercise program (n=14) or not to perform any physical activity beyond their usual daily requirements (n=11). At baseline and after 3, 6, 9 and 12 months, patients were assessed by manual muscle strength testing, the Ashworth spasticity scale, ALS functional rating scale (FRS), fatigue severity scale, a visual analogue scale for musculoskeletal pain and the quality-of-life scale (SF-36). At 3 months, patients who performed regular exercise showed less deterioration on FRS and Ashworth scales, but not on other parameters. At 6 months, there was no significant difference between groups, although a trend towards less deterioration in the treated group on most scales was observed. At 9 and 12 months, there were too few patients in each group for statistical evaluation. Our results show that a regular moderate physical exercise program has a short-lived positive effect on disability in ALS patients and should be recommended.
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                Author and article information

                Journal
                Intern Med
                Intern Med
                Internal Medicine
                The Japanese Society of Internal Medicine
                0918-2918
                1349-7235
                15 May 2022
                15 May 2022
                : 61
                : 10
                : 1479-1484
                Affiliations
                [1 ]Department of Neurology, Toho University Faculty of Medicine, Japan
                [2 ]Department of Rehabilitation Medicine, Toho University Faculty of Medicine, Japan
                [3 ]Department of Medical Statistics, Toho University Faculty of Medicine, Japan
                [4 ]Niigata National Hospital, National Hospital Organization, Japan
                Author notes

                Correspondence to Dr. Osamu Kano, osamu.kano@ 123456med.toho-u.ac.jp

                Article
                10.2169/internalmedicine.8030-21
                9177366
                35569927
                b3a77308-3b15-4f37-b0dc-31ca185ec69d
                Copyright © 2022 by The Japanese Society of Internal Medicine

                The Internal Medicine is an Open Access journal distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. To view the details of this license, please visit ( https://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 26 May 2021
                : 1 September 2021
                Categories
                Original Article

                amyotrophic lateral sclerosis,hybrid assistive limb,cyborg robot,rehabilitation,gait ability

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