Dataset Information

Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration.

Objective

This study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation.

Methods

This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention.

Results

This study began in November 2016 and is being conducted at 15 participating facilities in Japan.

Conclusions

Assessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting.

Trial registration

UMIN Clinical Trials Registry UMIN000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545.

SUBMITTER: Tsurushima H

PROVIDER: S-EPMC6913690 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial.

Tsurushima Hideo H Mizukami Masafumi M Yoshikawa Kenichi K Ueno Tomoyuki T Hada Yasushi Y Gosho Masahiko M Kohno Yutaka Y Hashimoto Koichi K Iizumi Yuichi Y Kikuchi Toshihiro T Matsumura Akira A

JMIR research protocols 20191011 10

<h4>Background</h4>Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration.<h4>Objective</h4>This study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improvin ...[more]

PMID: 31605515

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Project description:IntroductionRobotic therapy has drawn attention in the rehabilitation field including home-based rehabilitation. A previous study has reported that home-based therapy could be more effective for increasing upper limb activity than facility-based therapy. The single-joint hybrid assistive limb (HAL-SJ) is an exoskeleton robot developed according to the interactive biofeedback theory, and several studies have shown its effectiveness for upper limb function in stroke patients. A study of home-based robotic therapy has shown to enhance rehabilitation effectiveness for stroke patient with a paretic upper limb. However, home-based therapy involving a HAL-SJ in stroke patients with paretic upper limbs has not been investigated. The present study aimed to investigate paretic upper limb activity and function with home-based robotic therapy involving a HAL-SJ in stroke patients.Materials and methodsA home-based robotic therapy program involving a HAL-SJ was performed for 30 min per session followed by standard therapy for 30 min per session, 2 times a week, for 4 weeks (i.e., completion of all 8 sessions involved 8 h of rehabilitation), at home. After the intervention, patients were followed up by telephone and home visits for 8 weeks. The paretic upper limb activity and function were assessed using the Motor Activity Log (MAL; amount of use (AOU)), arm triaxial accelerometry (laterality index (LI)), the Fugl-Meyer assessment (FMA), and the action research arm test (ARAT), at baseline and week 4 and week 12 after the start of training.ResultsThe study included 10 stroke patients (5 men; mean age, 61.1 ± 7.1 years). The AOU scores and LI significantly improved at week 4 after the start of training (p<0.05). However, no significant changes were observed in the LI at week 12 (p=0.161) and the FMA scores at both week 4 and week 12 (p=0.059 and p=0.083, respectively). The ARAT scores significantly improved at both week 4 and week 12 (p<0.05).ConclusionHome-based robotic therapy combined with conventional therapy could be a valuable approach for increasing paretic upper limb activity and maintaining paretic upper limb function in the chronic phase of stroke.

Project description:BACKGROUND:Experimental designs using surrogate gait-like movements, such as in functional magnetic resonance imaging (MRI), cannot fully capture the cortical activation associated with overground gait. Overground gait in a robotic exoskeleton may be an ideal tool to generate controlled sensorimotor stimulation of gait conditions like 'active' (i.e. user moves with the device) and 'passive' (i.e. user is moved by the device) gait. To truly understand these neural mechanisms, functional near-infrared spectroscopy (fNIRS) would yield greater ecological validity. Thus, the aim of this experiment was to use fNIRS to delineate brain activation differences between 'Active' and 'Passive' overground gait in a robotic exoskeleton. METHODS:Fourteen healthy adults performed 10 walking trials in a robotic exoskeleton for Passive and Active conditions, with fNIRS over bilateral frontal and parietal lobes, and electromyography (EMG) over bilateral thigh muscles. Digitization of optode locations and individual T1 MRI scans were used to demarcate the brain regions fNIRS recorded from. RESULTS:Increased oxyhemoglobin in the right frontal cortex was found for Passive compared with Active conditions. For deoxyhemoglobin, increased activation during Passive was found in the left frontal cortex and bilateral parietal cortices compared with Active; one channel in the left parietal cortex decreased during Active when compared with Passive. Normalized EMG mean amplitude was higher in the Active compared with Passive conditions for all four muscles (p???0.044), confirming participants produced the conditions asked of them. CONCLUSIONS:The parietal cortex is active during passive robotic exoskeleton gait, a novel finding as research to date has not recorded posterior to the primary somatosensory cortex. Increased activation of the parietal cortex may be related to the planning of limb coordination while maintaining postural control. Future neurorehabilitation research could use fNIRS to examine whether exoskeletal gait training can increase gait-related brain activation with individuals unable to walk independently.

Project description:BackgroundThe possibility to modify the usually pathological patterns of coordination of the upper-limb in stroke survivors remains a central issue and an open question for neurorehabilitation. Despite robot-led physical training could potentially improve the motor recovery of hemiparetic patients, most of the state-of-the-art studies addressing motor control learning, with artificial virtual force fields, only focused on the end-effector kinematic adaptation, by using planar devices. Clearly, an interesting aspect of studying 3D movements with a robotic exoskeleton, is the possibility to investigate the way the human central nervous system deals with the natural upper-limb redundancy for common activities like pointing or tracking tasks.MethodsWe asked twenty healthy participants to perform 3D pointing or tracking tasks under the effect of inter-joint velocity dependant perturbing force fields, applied directly at the joint level by a 4-DOF robotic arm exoskeleton. These fields perturbed the human natural inter-joint coordination but did not constrain directly the end-effector movements and thus subjects capability to perform the tasks. As a consequence, while the participants focused on the achievement of the task, we unexplicitly modified their natural upper-limb coordination strategy. We studied the force fields direct effect on pointing movements towards 8 targets placed in the 3D peripersonal space, and we also considered potential generalizations on 4 distinct other targets. Post-effects were studied after the removal of the force fields (wash-out and follow up). These effects were quantified by a kinematic analysis of the pointing movements at both end-point and joint levels, and by a measure of the final postures. At the same time, we analysed the natural inter-joint coordination through PCA.ResultsDuring the exposition to the perturbative fields, we observed modifications of the subjects movement kinematics at every level (joints, end-effector, and inter-joint coordination). Adaptation was evidenced by a partial decrease of the movement deviations due to the fields, during the repetitions, but it occurred only on 21% of the motions. Nonetheless post-effects were observed in 86% of cases during the wash-out and follow up periods (right after the removal of the perturbation by the fields and after 30 minutes of being detached from the exoskeleton). Important inter-individual differences were observed but with small variability within subjects. In particular, a group of subjects showed an over-shoot with respect to the original unexposed trajectories (in 30% of cases), but the most frequent consequence (in 55% of cases) was the partial persistence of the modified upper-limb coordination, adopted at the time of the perturbation. Temporal and spatial generalizations were also evidenced by the deviation of the movement trajectories, both at the end-effector and at the intermediate joints and the modification of the final pointing postures towards targets which were never exposed to any field.ConclusionsSuch results are the first quantified characterization of the effects of modification of the upper-limb coordination in healthy subjects, by imposing modification through viscous force fields distributed at the joint level, and could pave the way towards opportunities to rehabilitate pathological arm synergies with robots.

Project description:BackgroundRobotic assisted gait training (RAGT) uses a powered exoskeleton to support an individual's body and move their limbs, with the aim of activating latent, pre-existing movement patterns stored in the lower spinal cord called central pattern generators (CPGs) to facilitate stepping. The parameters that directly stimulate the stepping CPGs (hip extension and ipsilateral foot unloading) should be targeted to maximise the rehabilitation benefits of these devices.AimTo compare the biomechanical profiles of individuals with a spinal cord injury (SCI) and able-bodied individuals inside the ReWalkTM powered exoskeleton and to contrast the users' profiles with the exoskeleton.MethodsEight able-bodied and four SCI individuals donned a ReWalkTM and walked along a 12-meter walkway, using elbow crutches. Whole-body kinematics of the users and the ReWalkTM were captured, along with GRF and temporal-spatial characteristics. Discreet kinematic values were analysed using a Kruskall-Wallis H and Dunn's post-hoc analysis. Upper-body differences, GRF and temporal-spatial characteristics were analysed using a Mann-Whitney U test (P<0.05).ResultsWalking speed ranged from 0.32-0.39m/s. Hip abduction, peak knee flexion and ankle dorsiflexion for both the SCI and able-bodied groups presented with significant differences to the ReWalkTM. The able-bodied group presented significant differences to the ReWalkTM for all kinematic variables except frontal plane hip ROM (P = 0.093,δ = -0.56). Sagittal plane pelvic and trunk ROM were significantly greater in the SCI vs. able-bodied (P = 0.004,δ = -1; P = 0.008,δ = -0.94, respectively). Posterior braking force was significantly greater in the SCI group (P = 0.004, δ = -1).DiscussionThe different trunk movements used by the SCI group and the capacity for the users' joint angles to exceed those of the device suggest that biomechanical profiles varied according to the user group. However, upright stepping with the ReWalkTM device delivered the appropriate afferent stimulus to activate CPGs as there were no differences in key biomechanical parameters between the two user groups.

Dataset Information

Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial.

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