Exoskeleton rehabilitation robot training for balance and lower limb function in sub-acute stroke patients: a pilot, randomized controlled trial

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Exoskeleton rehabilitation robot training for balance and lower limb function in sub-acute stroke patients: a pilot, randomized controlled trial

• Yuting Zhang,
• Weiwei Zhao,
• Chunli Wan,
• Xixi Wu,
• Junhao Huang,
• Xue Wang,
• Guilan Huang,
• Wenjuan Ding,
• Yating Chen,
• Jinyu Yang,
• Bin Su,
• Yi Xu,
• Zhengguo Zhou,
• Xuting Zhang,
• Fengdong Miao,
• Jianan Li &
• Yongqiang LI 

Journal of NeuroEngineering and Rehabilitation volume 21, Article number: 98 (2024) Cite this article

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Abstract

Purpose

This pilot study aimed to investigate the effects of REX exoskeleton rehabilitation robot training on the balance and lower limb function in patients with sub-acute stroke.

Methods

This was a pilot, single-blind, randomized controlled trial. Twenty-four patients with sub-acute stroke (with the course of disease ranging from 3 weeks to 3 months) were randomized into two groups, including a robot group and a control group. Patients in control group received upright bed rehabilitation (n = 12) and those in robot group received exoskeleton rehabilitation robot training (n = 12). The frequency of training in both groups was once a day (60 min each) for 5 days a week for a total of 4 weeks. Besides, the two groups were evaluated before, 2 weeks after and 4 weeks after the intervention, respectively. The primary assessment index was the Berg Balance Scale (BBS), whereas the secondary assessment indexes included the Fugl-Meyer Lower Extremity Motor Function Scale (FMA-LE), the Posture Assessment Scale for Stroke Patients (PASS), the Activities of Daily Living Scale (Modified Barthel Index, MBI), the Tecnobody Balance Tester, and lower extremity muscle surface electromyography (sEMG).

Results

The robot group showed significant improvements (P < 0.05) in the primary efficacy index BBS, as well as the secondary efficacy indexes PASS, FMA-LE, MBI, Tecnobody Balance Tester, and sEMG of the lower limb muscles. Besides, there were a significant differences in BBS, PASS, static eye-opening area or dynamic stability limit evaluation indexes between the robotic and control groups (P < 0.05).

Conclusions

This is the first study to investigate the effectiveness of the REX exoskeleton rehabilitation robot in the rehabilitation of patients with stroke. According to our results, the REX exoskeleton rehabilitation robot demonstrated superior potential efficacy in promoting the early recovery of balance and motor functions in patients with sub-acute stroke. Future large-scale randomized controlled studies and follow-up assessments are needed to validate the current findings.

Clinical trials registration

URL: https://www.chictr.org.cn/index.html.Unique identifier: ChiCTR2300068398.

Introduction

Stroke is the second leading cause of mortality and the third leading cause of disability worldwide [1]. During the recent decades, owing to rapid advancement in stroke treatment, global stroke mortality showed a significant decline [2]. Therefore, the total population of stroke survivors has increased and large population of stroke survivors would live with persistent dysfunctions. According to relevant statistics, more than 70% of stroke survivors will be left with motor, sensory, cognitive, and speech dysfunctions to varying degrees, which have resulted in the loss of personal labor force and posed a heavy burden on both the families and the society [3].

Balance, defined as the ability to maintain stable posture across diverse environments and conditions, is fundamental to all human static and dynamic activities [4]. Balance dysfunction may occur in more than 80% of stroke survivors, and is characterized by poor trunk control, insufficient muscle strength in the lower limbs, poor weight bearing in the affected lower limbs and slower walking speed [5, 6]. Such dysfunction can adversely affect mobility and quality of life [7]. Compromised balance is associated with an increased risk of falls [8], which may lead to restricted activities, physiological deconditioning, diminished independence, heightened fear of falling, and a higher incidence of subsequent falls [9]. In addition, balance is considered as an important factor for the walking ability of patients and is an important predictor of whether a patient will be able to walk independently [10]. Therefore, improving balance function and balance response strategies are the important goals in stroke rehabilitation programs [11].

Robotic training, characterized by high repetition, dosage, and intensity, has emerged as a cost-effective intervention in recent years [12]. Currently, exoskeleton rehabilitation robots ahave gained remarkable attention in recent years lower limb rehabilitation in stroke survivors [13]. While definitive evidence remains elusive regarding the superiority of exoskeleton-assisted training over conventional therapy, various studies have suggested it may enhance gait, ambulatory capabilities, balance, reduce muscle spasticity in the lower limbs, and improve cardiorespiratory fitness in individuals post-stroke [14, 15]. A meta-analysis has indicated that exoskeleton-assisted gait training is either beneficial or comparable to traditional rehabilitation methods for recovering gait and balance in stroke patients [16].

In this study, we utilized the REX robotic exoskeleton (REX Bionics PLC, London, UK), a self-stabilizing device that allows for the performance of upper body exercises in an upright position without the need for additional upper body support or balance aids, such as crutches or walking frames. This represents a significant deviation from other rehabilitation robot paradigms [17, 18]. Currently, there is only one study demonstrating the good feasibility, safety, and acceptability of the REX rehabilitation robot for the physical activity and upper body movement training in patients with spinal cord injury [19]. Therefore, the objective of this study is to investigate the effectiveness of REX exoskeleton rehabilitation robot training on the balance and lower limb function in patients with stroke in the sub-acute rehabilitation phase. Notably, we focused on determining whether REX exoskeleton rehabilitation robot training was superior to dose-matched conventional training with regard to the balance and lower limb function in patients with sub-acute stroke.