Abstract：
Balance impairments frequently occur after stroke. Achieving effective core trunk stability is the key to improving balance ability. However, there is still a lack of advanced well-defined rehabilitation protocols for balance improvement in patients with stroke. Intermittent theta-burst stimulation (iTBS) is a non-invasive brain activity modulation strategy that can produce long-term potentiation. The cerebellar vermis is a fundamental structure involved in balance and motor control. However, no study has demonstrated the therapeutic effect and potential mechanism of cerebellar vermis iTBS on balance after stroke.
This study will be a prospective single-centre double-blind randomised controlled clinical trial with a 3-week intervention and 3-week follow-up. Eligible participants will be randomly allocated to the experimental group or the control group in a 1:1 ratio. After routine conventional physical therapy, patients in the experimental group will receive cerebellar vermis iTBS, whereas patients in the control group will receive sham stimulation. The overall intervention period will be 5 days a week for 3 consecutive weeks. The outcomes will be measured at baseline (T0), 3 weeks postintervention (T1) and at the 3-week follow-up (T2). The primary outcomes are Berg Balance Scale and Trunk Impairment Scale scores. The secondary outcomes are balance test scores via the Balance Master system, muscle activation of the trunk and lower limbs via the surface electromyography recordings, cerebral cortex oxygen concentrations measured via the resting-state functional near-infrared spectroscopy, Fugl-Meyer Assessment of Lower Extremity and Barthel index scores.
This study was approved by the West China Hospital Clinical Trials and Biomedical Ethics Committee of Sichuan University. All participants will sign the informed consent form voluntarily. The results of this study will be published in peer-reviewed journals and disseminated at academic conferences.
ChiCTR2200065369.
This study will be a prospective single-centre double-blind randomised controlled clinical trial with a 3-week intervention and 3-week follow-up. Eligible participants will be randomly allocated to the experimental group or the control group in a 1:1 ratio. After routine conventional physical therapy, patients in the experimental group will receive cerebellar vermis iTBS, whereas patients in the control group will receive sham stimulation. The overall intervention period will be 5 days a week for 3 consecutive weeks. The outcomes will be measured at baseline (T0), 3 weeks postintervention (T1) and at the 3-week follow-up (T2). The primary outcomes are Berg Balance Scale and Trunk Impairment Scale scores. The secondary outcomes are balance test scores via the Balance Master system, muscle activation of the trunk and lower limbs via the surface electromyography recordings, cerebral cortex oxygen concentrations measured via the resting-state functional near-infrared spectroscopy, Fugl-Meyer Assessment of Lower Extremity and Barthel index scores.
This study was approved by the West China Hospital Clinical Trials and Biomedical Ethics Committee of Sichuan University. All participants will sign the informed consent form voluntarily. The results of this study will be published in peer-reviewed journals and disseminated at academic conferences.
ChiCTR2200065369.
摘要：
背景：平衡损害经常发生在卒中后。实现有效的核心主干稳定性是提高平衡能力的关键。然而,目前仍缺乏先进的明确的康复方案来改善卒中患者的平衡.间歇性theta爆发刺激（iTBS）是一种非侵入性脑活动调节策略，可以产生长期增强作用。小脑疣是涉及平衡和运动控制的基本结构。然而,目前尚无研究证实小脑疣iTBS对卒中后平衡的治疗作用和潜在机制。
方法：本研究将是一项前瞻性单中心双盲随机对照临床试验，为期3周的干预和3周的随访。符合条件的参与者将以1：1的比例随机分配到实验组或对照组。常规物理治疗后，实验组患者将接受小脑疣iTBS，而对照组的患者将接受假刺激。总体干预期将是每周5天，连续3周。结果将在基线(T0)测量，干预后3周（T1）和3周随访时（T2）。主要结果是Berg平衡量表和躯干损伤量表得分。次要结果是通过平衡主系统进行的平衡测试分数，通过表面肌电图记录激活躯干和下肢的肌肉，通过静息态功能近红外光谱测量大脑皮质氧浓度，Fugl-Meyer评估下肢和Barthel指数得分。
背景：本研究获得四川大学华西医院临床试验和生物医学伦理委员会批准。所有参与者将自愿签署知情同意书。这项研究的结果将发表在同行评审的期刊上，并在学术会议上传播。
背景：ChiCTR2200065369。
方法：本研究将是一项前瞻性单中心双盲随机对照临床试验，为期3周的干预和3周的随访。符合条件的参与者将以1：1的比例随机分配到实验组或对照组。常规物理治疗后，实验组患者将接受小脑疣iTBS，而对照组的患者将接受假刺激。总体干预期将是每周5天，连续3周。结果将在基线(T0)测量，干预后3周（T1）和3周随访时（T2）。主要结果是Berg平衡量表和躯干损伤量表得分。次要结果是通过平衡主系统进行的平衡测试分数，通过表面肌电图记录激活躯干和下肢的肌肉，通过静息态功能近红外光谱测量大脑皮质氧浓度，Fugl-Meyer评估下肢和Barthel指数得分。
背景：本研究获得四川大学华西医院临床试验和生物医学伦理委员会批准。所有参与者将自愿签署知情同意书。这项研究的结果将发表在同行评审的期刊上，并在学术会议上传播。
背景：ChiCTR2200065369。
