Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 15
- 主要终点
- Changes in Emerging Behaviors Scale (EBS) Score
研究概览
简要总结
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).
详细描述
The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 216 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child will be 8 - 36 months old when study treatment will be delivered
- •child has a diagnosis of Perinatal Arterial Stroke (PAS)
- •parent permission to provide the child's clinical MRI to the study
- •child has hemiparesis
- •parent(s) willing to participate in the home therapy component
- •one parent English language proficient and will take the lead in interacting with study staff and completing self-administered forms and interviews in English
排除标准
- •child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health)
- •child previously received Constraint-Induced Movement Therapy (CIMT) or modified CIMT with a dose of at least 2 hrs/day for ≥10 days
- •child received botulinum toxin in past 3 months
- •child is a ward of the state or other agency
研究组 & 干预措施
I-ACQUIRE High Dose
High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)
干预措施: I-ACQUIRE - High Dosage (Behavioral)
I-ACQUIRE Moderate Dose
Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)
干预措施: I-ACQUIRE - Moderate Dosage (Behavioral)
Usual & Customary Treatment
Usual & Customary Treatment
干预措施: Usual & Customary Treatment (U&CT) (Behavioral)
结局指标
主要结局
Changes in Emerging Behaviors Scale (EBS) Score
时间窗: Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
The primary efficacy is measured by the Emerging Behaviors Scale (EBS) that counts the number of upper extremity skills on the hemiparetic side that the child displays (from 0 to 30). The source for observation comes from a battery of standardized age-appropriate neuromotor assessment tools (Gross Motor Function Measure-66, The Bayley III Fine and Gross Motor scales, unilateral skills during the Mini AHA) and independent observational coding of the videotaped assessment session with supplemental parent ratings on the Infant Motor Activity Log and daily skills on the MacArthur-Bates Communicative Development Inventory. A favorable outcome is defined as a gain of ≥7 new EBS skills above the child's baseline (pre-treatment) score. The EBS requires evidence of each skill from at least two independent sources.
次要结局
- Changes in Bilateral Use of the Hemiparetic Upper Extermity based on the Mini-Assisting Hand Assessment (Mini-AHA) play assessment(Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment)
研究者
Sharon Ramey
Distinguished Research Scholar and Professor
Virginia Polytechnic Institute and State University