Investigating the Effectiveness of Robotic-Assisted Gait Training (RAGT) in the Rehabilitation of Children With Neurological Impairment Due to Acquired Brain Injury or Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- change in GMFM-88: total score and Dimensions
研究概览
简要总结
The recovery of walking ability is one of the primary rehabilitation goals for children with neurological impairment. The aim of the study is to investigate the clinical effectiveness of rehabilitation treatments based of Robotic-Assisted Gait Training (RAGT). Additional goals of the research are to identify the specific effects of RAGT in children with different etiologies (acquired brain injury and cerebral palsy) and with different levels of function (according to the Gross Motor Function Classification System).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acquired brain injury in pediatric age and adolescence (4 to 18 years) or cerebral palsy;
- •Femur length of at least 23 cm;
- •Patients able to signal pain, fear or discomfort reliably and to follow simple instructions.
排除标准
- •injection of botulinum toxin during the 6 months prior to the enrollment;
- •oral medications reducing muscle tone;
- •previous orthopedic surgery;
- •severe lower-extremity contractures;
- •fractures or osseous instabilities;
- •osteoporosis;
- •contraindication of full body load due to previous surgeries;
- •severe retarded bone growth;
- •unhealed skin lesions in the lower-extremities;
- •thromboembolic diseases
- •cardiovascular instability
- •acute or progressive neurological disorders
- •aggressive or self-harming behavior.
结局指标
主要结局
change in GMFM-88: total score and Dimensions
时间窗: After four weeks of treatment
The Gross Motor Function Measure (GMFM) measures the child's overall functional abilities, and is divided into the following sections: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running, and jumping.
Change in 6minWT distance walked
时间窗: After four weeks of treatment
The 6-minute walk test (6minWT) was used to assess endurance during self-paced, submaximal walk by measuring the distance walked within 6 minutes along a standardized route through the hospital corridors.
次要结局
- change in kinematic gait parameters(After four weeks of treatment)
- change in FAQ score(After four weeks of treatment)
- Lokomat therapy total distance walked(After four weeks of treatment)
- Lokomat therapy total time walked(After four weeks of treatment)
- Lokomat therapy duration(After four weeks of treatment)
- Lokomat force values (LForce)(After four weeks of treatment)
- Lokomat stiffness values (LStiff)(After four weeks of treatment)
- change in spatiotemporal gait parameters(After four weeks of treatment)
- change in kinetic gait parameters(After four weeks of treatment)