The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Wuxi Central Rehabilitation Hospital, The Affiliated Mental Health Center of Jiangnan University, Wuxi, Jiangsu, China.
J Neuroeng Rehabil. 2024 Jun 8;21(1):98. doi: 10.1186/s12984-024-01391-0.
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.
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).
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).
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.
URL: https://www.chictr.org.cn/index.html.Unique identifier: ChiCTR2300068398.
本研究旨在探讨 RE X 外骨骼康复机器人训练对亚急性脑卒中患者平衡和下肢功能的影响。
这是一项前瞻性、单盲、随机对照试验。将 24 例亚急性脑卒中患者（病程 3 周至 3 个月）随机分为机器人组和对照组。对照组接受直立床康复治疗（n=12），机器人组接受外骨骼康复机器人训练（n=12）。两组患者每天训练 1 次（每次 60 分钟），每周 5 天，共 4 周。此外，两组分别在干预前、干预后 2 周和干预后 4 周进行评估。主要评估指标为 Berg 平衡量表（BBS），次要评估指标包括 Fugl-Meyer 下肢运动功能量表（FMA-LE）、脑卒中患者姿势评估量表（PASS）、日常生活活动量表（改良巴氏指数，MBI）、Tecnobody 平衡测试仪和下肢肌肉表面肌电图（sEMG）。
机器人组的主要疗效指标 BBS 以及次要疗效指标 PASS、FMA-LE、MBI、Tecnobody 平衡测试仪和下肢肌肉 sEMG 均有显著改善（P<0.05）。此外，机器人组和对照组在 BBS、PASS、睁眼静态面积或动态稳定极限评估指标方面存在显著差异（P<0.05）。
这是首次研究 RE X 外骨骼康复机器人在脑卒中患者康复中的有效性。根据我们的结果，RE X 外骨骼康复机器人在促进亚急性脑卒中患者平衡和运动功能早期恢复方面具有潜在的优势。需要进一步进行大规模的随机对照研究和随访评估来验证当前的研究结果。
网址：https://www.chictr.org.cn/index.html.唯一标识符：ChiCTR2300068398。
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