Efficacy of a Novel Exoskeletal Robot for Locomotor Rehabilitation in Stroke Patients: A Multi-center, Non-inferiority, Randomized Controlled Trial

Abstract

Objective: To investigate the efficacy and safety of a novel lower-limb exoskeletal robot, BEAR-H1 (Shenzhen Milebot Robot Technology), in the locomotor function of subacute stroke patients.Methods: The present study was approved by the ethical committee of the First Affiliated Hospital of Nanjing Medical University (No. 2019-MD-43), and registration was recorded on the Chinese Clinical Trial Registry with a unique identifier: ChiCTR2100044475. A total of 130 patients within 6 months of stroke were randomly divided into two groups: the robot group and the control group. The control group received routine training for walking, while in the robot group, BEAR-H1 lower-limb exoskeletal robot was used for locomotor training. Both groups received two sessions daily, 5 days a week for 4 weeks consecutively. Each session lasted 30 min. Before treatment, after treatment for 2 weeks, and 4 weeks, the patients were assessed based on the 6-minute walking test (6MWT), functional ambulation scale (FAC), Fugl-Meyer assessment lower-limb subscale (FMA-LE), and Vicon gait analysis.Results: After a 4-week intervention, the results of 6MWT, FMA-LE, FAC, cadence, and gait cycle in the two groups significantly improved (P < 0.05), but there was no significant difference between the two groups (P > 0.05). The ratio of stance phase to that of swing phase, swing phase symmetry ratio (SPSR), and step length symmetry ratio (SLSR) was not significantly improved after 4 weeks of training in both the groups. Further analyses revealed that the robot group exhibited potential benefits, as the point estimates of 6MWT and Δ6MWT (post-pre) at 4 weeks were higher than those in the control group. Additionally, within-group comparison showed that patients in the robot group had a significant improvement in 6MWT earlier than their counterparts in the control group.Conclusions: The rehabilitation robot in this study could improve the locomotor function of stroke patients; however, its effect was no better than conventional locomotor training.

The effect of robotized knee-ankle-foot orthosis-assisted gait training on genu recurvatum during gait: a safety and feasibility study in healthy participants and patients with chronic stroke

“…Voluntary ankle dorsi exion movement improved despite the chronic phase. Previous studies in patients with acute and sub-acute stroke have reported improvement in FMA-LE with robot-assisted gait training [31][32][33][34][35][36]. Although some studies have shown similar improvements in FMA-LE after robotassisted gait training in patients with chronic stroke [37,38], the number of sessions or duration of intervention were longer than in our intervention.…”

Use of Robotics in Gait Rehabilitation Following Stroke: A Review

“…In adults, stroke is the major factor causing a long-time impairment. The occurrence of hemiplegia is growing annually as a result of an aging population and in emergency treatment, resulting in considerable medical and societal consequences [ 4 ]. Motor loss is a very well consequence of stroke because it impairs muscle function and movement.…”

“…Involvement in gait-related activities includes not just walking activity but also taking into account the context and surroundings as it changes when walking, such as uneven terrain, level differences, avoiding obstacles, and crowding [ 5 , 6 ]. Most stroke patients have an asymmetric walking pattern, lower-extremity stiffness on the affected (hemiplegic) side, and impaired single stance and weight transfer capacity, restricting their locomotor function [ 4 ]. While the majority of recovery is expected to occur within the first few weeks following hemiplegia, individuals may continue to make progress on functional activities for many months [ 7 , 8 ].…”

“…Twenty percent of people remain wheelchair-bound for three months following a stroke, and around 70 percent walk at a decreased speed and ability [ 9 ]. Although 65-85 percent of patients may walk independently within six months after a stroke with appropriate [ 4 ] surgical/pharmaceutical procedures and rehabilitative therapy. Poor gait and cardiopulmonary endurance continue to impede everyday walking for stroke patients [ 4 ].…”

“…Although 65-85 percent of patients may walk independently within six months after a stroke with appropriate [ 4 ] surgical/pharmaceutical procedures and rehabilitative therapy. Poor gait and cardiopulmonary endurance continue to impede everyday walking for stroke patients [ 4 ].…”