[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of botulinum toxin type A (Hengli®) for injection in the treatment of spasticity in children with spastic cerebral palsy
主要目的:
? 在联合康复训练的基础上验证注射用A型肉毒毒素(衡力®)对于改善痉挛型脑性瘫痪儿童下肢痉挛状态在4周踝跖屈肌群改良Ashworth量表评分的有效性上优于安慰剂。
次要目的:
? 评价注射用A型肉毒毒素(衡力®)联合康复训练对于改善痉挛型脑性瘫痪儿童下肢痉挛状态在肌张力和痉挛评价、步态、功能改善上的有效性;
? 评价注射用A型肉毒毒素(衡力®)治疗痉挛型脑性瘫痪儿童下肢痉挛状态的安全性。
[Translation] main purpose:
? On the basis of combined rehabilitation training, it is verified that botulinum toxin type A (Hengli®) for injection is more effective in improving lower limb spasticity in children with spastic cerebral palsy in the modified Ashworth scale score of ankle plantar flexor group at 4 weeks. placebo.
Secondary purpose:
? To evaluate the effectiveness of botulinum toxin type A (Hengli®) for injection combined with rehabilitation training in improving the spasticity of lower limbs in children with spastic cerebral palsy in the evaluation of muscle tone and spasticity, gait and function improvement;
? To evaluate the safety of botulinum toxin type A (Hengli®) for injection in the treatment of lower extremity spasticity in children with spastic cerebral palsy.