Use of Elastography to Quantify Change in Upper Extremity Muscle Spasticity Following Botox Injection in Children With Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Muscle Elasticity
研究概览
简要总结
To date, clinical tests are unable to differentiate between the cause of muscle stiffness, although a manual instrumented spasticity assessment for the lower limb that utilizes surface electromyogram has recently been proposed. This study intends to use shear wave elastography to assess individual muscle stiffness parameters and the individual response to botulinum toxin injection in the elbow and wrist flexors. Collection of baseline spasticity parameters could then be used to predict the effect of botulinum toxin type A and ultimately serve as a basis for development of a treatment model for muscle spasticity in patients with spastic cerebral palsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral spastic cerebral palsy with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent.
- •Consent may be obtained from a parent or legal guardian, as applicable.
排除标准
- •Prior surgical procedure in the affected upper extremity
- •Unrelated orthopedic injury to the affected upper extremity
- •Current oral or intrathecal antispasticity therapy
- •Prior Botulinum toxin type A injection in preceding 6 months
结局指标
主要结局
Muscle Elasticity
时间窗: From immediate pre-injection to 1 month post-injection.
Change in muscle elasticity (in m/s)
次要结局
- Functional measures(immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.)