Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Gross Motor Function Measure (GMFM) (for bilateral CP only)
研究概览
简要总结
An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.
详细描述
The primary objective of this study is to evaluate the effect of two weeks of early HABIT-ILE on gross motor function in pre-school children with unilateral and and bilateral Cerebral Paralysy (CP), in comparison with two weeks of usual motor activity including usual rehabilitation (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child with unilateral cerebral palsy or Child with bilateral cerebral palsy proven spastic or dyskinetic
- •Aged from 1 to 4 years old (12 to 59 months) (age corrected if prematurity) able to follow instructions and to be able to carry out all the evaluations, according to his age
排除标准
- •Age> 2 years old (35 months) or 4 years old (59 months) during the internship evaluation period
- •Uncontrolled epilepsy
- •History of botulinum toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period)
- •Visual or cognitive impairment that may interfere with the management
- •Common contraindications to magnetic resonance imaging (MRI) such as metal implants
结局指标
主要结局
Gross Motor Function Measure (GMFM) (for bilateral CP only)
时间窗: 1 hour
measures change in gross motor function over time in children with cerebral palsy. The score range from 0 to 100 as a percentage. 100 is the best outcome.
Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only)
时间窗: 1 hour
measures and describes how children with upper limb disability in one hand use his/her affected hand collaboratively with the non affected hand in bimanual play.The score range from 0 to 100 as a percentage. 100 is the best outcome.
次要结局
未报告次要终点