NCT04882592招募中1 期
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- SpineX Inc.
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Gross Motor Functional Measure (GMFM)
研究概览
简要总结
Assessing the effects of noninvasive spinal cord neuromodulation on improving function in individuals with cerebral palsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals above the age of 2 years of age and 2) diagnosed with cerebral palsy (CP). The
排除标准
- •included 1) children with selective dorsal root rhizotomy, 2) intramuscular Botox injection in the preceding 12 months, 3) current antispastic medications 4) unhealed fractures or contractures that would prevent them from performing functional tasks and 5) tendon lengthening surgeries.
- •Exclusion Criteria:
- •Intramuscular Botox injection in the past 12 months
研究组 & 干预措施
Therapeutic Arm
Experimental
Spinal Cord Neuromodulation with SCiP during Activity Based NeuroRehab Therapy
干预措施: SCiP (Device)
Sham Arm
Sham Comparator
Sham Stimulation during Activity Based NeuroRehab Therapy
干预措施: SCiP (Device)
结局指标
主要结局
Gross Motor Functional Measure (GMFM)
时间窗: 3 months
Stepping overground or on a treadmill
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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