The Effect of a Comprehensive Rehabilitation Program Using Robotic Walking and Functional Electrical Stimulation Technologies on Balance and Walking in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Range of motion of joints during the gait cycle
研究概览
简要总结
The aim of this study was to investigate the effect of a comprehensive rehabilitation program using robotic walking and functional electrical stimulation technologies on balance and gait in children with cerebral palsy. This study was planned as a prospective observational study. A total of 30 patients in two groups were planned to be included in the study. Patients in both groups were planned to receive a 6-week conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. The case group was planned to consist of patients who received a comprehensive rehabilitation program using high-tech devices including functional electrical stimulation (FES) and robotic rehabilitation applications in addition to the conventional rehabilitation program.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 2-18
- •Being diagnosed with cerebral palsy
- •Walking independently with or without an assistive walking device
- •Having a GMFCS score between 1-3
- •Lack of seizure history
- •Showing consent to participate in the study (signing the informed consent by the legal guardian of the patient)
排除标准
- •Presence of contracture in lower extremities
- •Being administered botulinum toxin within the last one month before treatment or during the 6-week treatment period
- •Being unable to cooperate with clinical assessments
结局指标
主要结局
Range of motion of joints during the gait cycle
时间窗: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Range of motion of the knee, hip and ankle joint during the gait cycle
Cadence
时间窗: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
The number of steps taken per minute
Plantar surface pressure distribution
时间窗: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Plantar surface pressure distribution measured by pedobarograph
Stride length
时间窗: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
The distance between the consecutive initial contacts of the same foot
Range of motion of the pelvis in the frontal plane during the gait cycle
时间窗: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Range of motion of the pelvis in the frontal plane during the gait cycle
Step length
时间窗: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
The distance between the initial contact of one foot and the initial contact of the contralateral foot
Track width
时间窗: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
The mediolateral distance between right and left heels during gait
次要结局
- Spasticity(The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program)
- Balance(The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program)
- Gait speed(The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program)