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分层干预中的机器人辅助治疗:一项关于中风后运动恢复的随机对照试验

Robot-assisted therapy in stratified intervention: a randomized controlled trial on poststroke motor recovery.

作者信息

Liu Yang, Cui Lijun, Wang Jixian, Xiao Zihao, Chen Zhi, Yan Jin, Niu Chuanxin M, Xie Qing

机构信息

Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

Department of Rehabilitation Medicine, Ruijin Rehabilitation Hospital, Shanghai, China.

出版信息

Front Neurol. 2024 Sep 26;15:1453508. doi: 10.3389/fneur.2024.1453508. eCollection 2024.

Abstract

OBJECTIVE

To compare the effects of robot-assisted therapy with conventional therapy for accelerating stratified intervention in poststroke patients with upper limb dysfunction.

BACKGROUND

For stroke survivors, recovery of upper extremity function remains a major challenge in rehabilitation. Literature has suggested that the rate of recovery may improve if treatments can be individualized to their clinical profiles. However, there still lack clinical evidence on how to create treatment tailored to individual patients. Robot-assisted Therapy (RT) provides a straightforward approach to adjustment of the assistance-resistance continuum for individual patients. In early Brunnstrom stages of recovery, patients benefit from assistance training, whereas in later stages the training is favored with resistance. Therefore, RT may enhance Conventional Therapy (CT) but the use of RT in stratified intervention has not been investigated. This study evaluated the possible benefit of adopting RT following a protocol of upper-limb training, which was stratified with the Brunnstrom stage of each individual.

METHODS

This study was a single-blinded randomized controlled trial. A total of 53 patients with stroke were recruited and randomized into 2 groups (CT,  = 27, 3 dropped out and RT,  = 26, 2 dropped out). Both groups were trained once per day, 5 days per week for 4 weeks. The CT group received 30 min of conventional therapy; the RT group received 30 min of upper limb robot-assisted training. Patients were assessed at the beginning, week-2, and week-4 of the treatment. The outcome measures included the Fugl-Meyer Assessment Upper-Extremity (FMA-UE) and the Modified Barthel Index (MBI).

RESULTS

Across the 4-week intervention, participants in the RT group recovered 1.979 points of FMA-UE per week, compared to 1.198 points per week in the CT group (t = 3.333, < 0.01); the recovery rate was 0.781 points/week higher in the RT group than in the CT group. Moreover, the recovery of FMA-UE was faster in proximal joints (t = 3.199, < 0.01), and for patients in Brunnstrom Stage III (t = 2.526, < 0.05). The improvements in MBI were not significantly different between RT and CT.

CONCLUSION

Robot-assisted therapy showed initial evidence for the acceleration of post-stroke recovery of motor function in the upper limb. Initial observations suggested that patients in Brunnstrom recovery stage III might benefit the most from the stratified intervention assisted by robotics.

CLINICAL TRIAL REGISTRATION

https://www.chictr.org.cn/showproj.html?proj=61834, Identifier [ChiCTR2000039010]. Registered 13 March 2020.

摘要

目的

比较机器人辅助治疗与传统治疗对加速脑卒中上肢功能障碍患者分层干预的效果。

背景

对于脑卒中幸存者而言,上肢功能恢复仍是康复过程中的一项重大挑战。文献表明,如果治疗能够根据患者的临床特征进行个体化调整,恢复速度可能会提高。然而,关于如何为个体患者制定个性化治疗方案仍缺乏临床证据。机器人辅助治疗(RT)为针对个体患者调整辅助-阻力连续体提供了一种直接的方法。在恢复的早期Brunnstrom阶段,患者从辅助训练中获益,而在后期阶段,训练则更倾向于阻力训练。因此,RT可能会增强传统治疗(CT),但RT在分层干预中的应用尚未得到研究。本研究评估了按照上肢训练方案采用RT的可能益处,该方案根据每个个体的Brunnstrom阶段进行分层。

方法

本研究为单盲随机对照试验。共招募了53例脑卒中患者,并随机分为两组(CT组,n = 27,3例退出;RT组,n = 26,2例退出)。两组均每天训练1次,每周训练5天,共训练4周。CT组接受30分钟的传统治疗;RT组接受30分钟的上肢机器人辅助训练。在治疗开始时、第2周和第4周对患者进行评估。结局指标包括Fugl-Meyer上肢评估量表(FMA-UE)和改良Barthel指数(MBI)。

结果

在为期4周的干预过程中,RT组参与者FMA-UE每周恢复1.979分,而CT组为每周1.198分(t = 3.333,P < 0.01);RT组的恢复率比CT组高0.781分/周。此外,近端关节的FMA-UE恢复更快(t = 3.199,P < 0.01),且Brunnstrom III期患者的恢复更快(t = 2.526,P < 0.05)。RT组和CT组在MBI改善方面无显著差异。

结论

机器人辅助治疗初步证明可加速脑卒中后上肢运动功能的恢复。初步观察表明,处于Brunnstrom恢复III期的患者可能从机器人辅助的分层干预中获益最大。

临床试验注册

https://www.chictr.org.cn/showproj.html?proj=61834,标识符[ChiCTR2000039010]。于20年3月13日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/11464483/48ed7fd263f6/fneur-15-1453508-g001.jpg

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