Promoting Upright Mobility in Infants With Cerebral Palsy Using a Robotic Unweighting System
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in the Bayley IV age equivalents and the GMFM-66
研究概览
简要总结
BabyG is a soft harness attached to a robotic system mounted overhead. While wearing the harness, the infant is free to move around a 10-by-10-foot play area with a padded floor. The harness helps support the infant s weight; it also slows any falls and catches the body before it hits the floor. BabyG can be adjusted to support 5% to 50% of the infant s weight.
Participants will be in the study for 24 weeks, including 12 weeks with BabyG training and 12 weeks without. Training will be 90 minutes per week: either two 45-minute sessions or three 30-minute sessions.
All participants will undergo tests during the 24 weeks such as:
A test to measure an infant s ability to perform tasks such as rolling, sitting, crawling, and walking.
A test to assess nerve function, movements, reflexes, posture, and muscle tone.
A test of brain activity while moving. The infant will be fitted with a snug cap with 64 electrodes. Then the infant will be placed in the BabyG harness and encouraged to take steps on a motorized treadmill. Their movements will be filmed.
详细描述
Study Description:
This phase IIb randomized crossover trial will evaluate the effects of 12 weeks of mobility training while in a computer-controlled (robotic) unweighting system (BabyG) on motor development rate in infants diagnosed with or at high risk for cerebral palsy (CP) who are less than 18 months old at enrollment compared to a 12-week period when they are not participating in training.
Objectives:
- Primary 1: Evaluate the effects of mobility training with the BabyG robotic unweighting system on motor developmental rate in infants from 5 -18 months compared to an equivalent amount of time when they are not doing the training.
- Primary 2: Evaluate the effects of BabyG mobility training on EEG brain activation patterns during treadmill stepping with the least amount of support needed in infants 5 -18 months, as compared to an equivalent amount of time when they are not doing the training.
- Secondary 1: Evaluate changes in muscle size of the rectus femoris and gastrocnemius muscles as assessed by muscle ultrasound before and after training and compared across training and no-training periods.
- Secondary 2: Relate the age at which the infant starts and their compliance with the BabyG training (total training time) with their
post-training outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in the Bayley IV age equivalents and the GMFM-66
时间窗: 48 months
Compare change in the Bayley IV age equivalents and the GMFM-66 during the training and no-training periods.
Changes in EEG brain activity
时间窗: 48 months
Changes in EEG brain activity during supported stepping on an infant treadmill as a result of training. We will quantify and compare changes in the magnitude of activation in multiple EEG frequency bands in motor-related brain regions after training and no-training periods.
次要结局
- Changes in brain activation(48 months)
- The absolute and percent change in muscle size of two muscle groups as a result of training(48 months)
- Infant age in months and the total training time in minutes(48 months)