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Randomized Controlled Trial
. 2024 Jun 8;21(1):98.
doi: 10.1186/s12984-024-01391-0.

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

Yuting Zhang  1 , Weiwei Zhao  2 , Chunli Wan  1 , Xixi Wu  3 , Junhao Huang  4 , Xue Wang  1 , Guilan Huang  2 , Wenjuan Ding  2 , Yating Chen  2 , Jinyu Yang  2 , Bin Su  2 , Yi Xu  5 , Zhengguo Zhou  5 , Xuting Zhang  5 , Fengdong Miao  5 , Jianan Li  1 , Yongqiang Li  6
Affiliations
Randomized Controlled Trial

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

Yuting Zhang et al. J Neuroeng Rehabil. .

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.

Keywords: Balance function; Lower limb function; Rehabilitation robot; Stroke.

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Conflict of interest statement

The authors declare no competing interests.

We declare that we have no financial and personal relationships with other people ororganizations that can inappropriately influence our work, there is no professional orother personal interest of any nature or kind in any product, service and/or companythat could be construed as influencing the position presented in, or the review of, the manuscript entitled.

Figures

Fig. 1
Fig. 1
(A): Standing balance training. (B): Elastic band resistance training. (C): Lower limb function training. (D): Rex robot structure
Fig. 2
Fig. 2
Altogether 58 patients were screened for eligibility and finally 24 of them were enrolled for analysis
Fig. 3
Fig. 3
Changes in assessment metrics before intervention (T0), after 2 weeks of intervention (T2), and after 4 weeks of intervention (T4)
See this image and copyright information in PMC

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