RATIONALE Restoration of adequate standing balance after stroke is of major importance for functional recovery. POstural feedback ThErapy combined with Non-invasive TranscranIAL direct current stimulation (tDCS) in patients with stroke (POTENTIAL) aims to establish if cerebellar tDCS has added value in improving standing balance performance early post-stroke. METHODS Forty-six patients with a first-ever ischemic stroke will be enrolled in this double-blind controlled trial within five weeks post-stroke. All patients will receive 15 sessions of virtual reality-based postural feedback training (VR-PFT) in addition to usual care. VR-PFT will be given five days per week for 1 h, starting within five weeks post-stroke. During VR-PFT, 23 patients will receive 25 min of cerebellar anodal tDCS (cb_tDCS), and 23 patients will receive sham stimulation. STUDY OUTCOME Clinical, posturographic, and neurophysiological measurements will be performed at baseline, directly post-intervention, two weeks post-intervention and at 15 weeks post-stroke. The primary outcome measure will be the Berg Balance Scale (BBS) for which a clinical meaningful difference of six points needs to be established between the intervention and control group at 15 weeks post-stroke. DISCUSSION POTENTIAL will be the first proof-of-concept randomized controlled trial to assess the effects of VR-PFT combined with cerebellar tDCS in terms of standing balance performance in patients early post-stroke. Due to the combined clinical, posturographical and neurophysiological measurements, this trial may give more insights in underlying post-stroke recovery processes and whether these can be influenced by tDCS.

中文翻译：

---

小脑经颅直流电刺激对改善中风后早期站立平衡能力的影响，随机对照试验的研究方案。


基本原理 中风后恢复足够的站立平衡对于功能恢复至关重要。姿势反馈疗法结合无创经颅直流电刺激 (tDCS) 治疗中风患者 (POTENTIAL)，旨在确定小脑 tDCS 是否对改善中风后早期站立平衡能力具有附加价值。方法 46 名首次发生缺血性中风的患者将在中风后五周内参加这项双盲对照试验。除常规护理外，所有患者还将接受 15 次基于虚拟现实的姿势反馈训练 (VR-PFT)。 VR-PFT 将在中风后五周内开始，每周进行五天，每次 1 小时。在 VR-PFT 期间，23 名患者将接受 25 分钟的小脑阳极 tDCS (cb_tDCS)，23 名患者将接受假刺激。研究结果 将在基线、干预后、干预后两周和卒中后 15 周进行临床、姿势描记学和神经生理学测量。主要结果测量将是 Berg 平衡量表 (BBS)，需要在中风后 15 周时在干预组和对照组之间建立 6 分的临床有意义的差异。讨论潜力将是第一个概念验证随机对照试验，旨在评估 VR-PFT 联合小脑 tDCS 对中风后早期患者站立平衡能力的影响。由于结合了临床、姿势描记学和神经生理学测量，该试验可能会为潜在的中风后恢复过程以及这些过程是否会受到 tDCS 的影响提供更多见解。