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围产期动脉缺血性中风第3期试验方案,用于婴幼儿强化康复 (I-ACQUIRE)

Sharon Landesman Ramey¹, Warren D Lo^2,3, Stephanie C DeLuca¹

¹Fralin Biomedical Research Institute at VTC, Virginia Tech, Roanoke (S.L.R., S.C.D., C.T.R.).

|February 6, 2026

概括

患有围产动脉缺血性中风 (PAIS) 的婴儿可能会从I-ACQUIRE康复治疗中受益. 这一第三期试验比较了高剂量,中剂量和常规护理,评估了幼儿的运动技能改善.

科学领域:

儿科神经学儿科神经学
康复医学康复医学康复医学
临床试验临床试验

背景情况:

周产期动脉缺血性中风 (PAIS) 对婴幼儿的终身神经运动障碍构成重大风险.
来自第三阶段临床试验的证据对于确定有效的治疗方法来改善这些儿童的治疗结果至关重要.

研究的目的:

评估I-ACQUIRE干预的有效性,这是一个多组件,由治疗师提供的计划,用于改善PAIS的婴儿和幼儿的治疗结果.
为了在3期随机临床试验中比较I-ACQUIRE的两个剂量与通常和习惯性护理.

主要方法:

I-ACQUIRE 3期试验是一项15个地点的随机对照试验,涉及8-36个月的PAIS和半的儿童.
参与者被随机分配到高剂量I-ACQUIRE,中等剂量I-ACQUIRE或常规和习惯性治疗.
主要结局是单方面技能,包括双手活动 (迷你辅助手评估).

主要成果:

该试验招募了216名儿童,其中168人是修改后的治疗意图样本 (平均年龄为18.0个月).
该样本包括大多数右侧半 (70%) 和51%的患者.
孩子们表现出各种各样的功能能力和父母评估的运动技能.

结论:

该试验确定了高疗效值,并包括对差异性治疗反应的分析.
任何I-ACQUIRE剂量的积极结果都将提供第三阶段证据,以指导婴幼儿康复决策.

关键词:

脑性麻脑性麻是一种约束诱导的运动疗法发展障碍发展障碍发展障碍半麻症是一种半麻症.缺血性中风中风中风康复中风康复中风康复

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