Cerebral Palsy (CP) is the most common pediatric motor disability with multiple symptoms and etiologies. CP is exhibited through sensorimotor delays, impaired posture resulting in limited activities and participation. Our recently concluded, single arm, unblinded, pilot study (NCT04882592) explored whether an intervention combining non-invasive spinal neuromodulation during an activity-based neurorehabilitation therapy (ABNT) can improve voluntary sensory-motor function captured via the Gross Motor Function Measure (GMFM-88) scores (primary outcome). Sixteen children diagnosed with CP with Gross Motor Function Classification Scale levels I-V were recruited and received the same intervention (2x/week for 8 weeks) to correct the dysfunctional connectivity between supraspinal and spinal networks using the normally developed proprioception. We demonstrate that the intervention was associated with clinically and statistically significant improvement in GMFM-88 scores in all children, thus meeting the prespecified primary endpoint. However, the improvement with ABNT alone needs further exploration. No serious adverse events were observed (safety endpoint).

脑瘫 (CP) 是最常见的小儿运动障碍，具有多种症状和病因。CP 表现为感觉运动迟缓、姿势受损导致活动和参与受限。我们最近结束的单臂非盲试验研究 (NCT04882592) 探讨了在基于活动的神经康复治疗 (ABNT) 期间结合非侵入性脊髓神经调节的干预是否可以改善通过粗大运动功能测量 (GMFM) 捕获的自主感觉运动功能-88) 分数（主要结果）。招募了 16 名诊断为粗大运动功能分类量表 IV 级 CP 的儿童，并接受相同的干预（每周 2 次，持续 8 周），以使用正常发育的本体感觉纠正脊髓上网络和脊柱网络之间的功能障碍连接。我们证明干预与所有儿童的 GMFM-88 评分在临床和统计学上的显着改善相关，从而达到了预先指定的主要终点。然而，单独使用 ABNT 的改进需要进一步探索。没有观察到严重的不良事件（安全终点）。