Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Ability and quality of walking.
研究概览
简要总结
The improvement of walking capacity is a key objective of the rehabilitation of children with PC. There are different approaches from physiotherapy to address this need, including walking on the ground and on treadmill with partial weight support. Currently, there are robotic technologies adapted to the functional rehabilitation of patients. Assisted gait training with robotic devices such as the Walkbot allows a longer duration of training, at more variable speeds, and with a constant gait pattern adapted to the patient. This training, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions.
There are some studies that evaluate walking interventions on treadmill with partial weight support, on the ground and in assisted walking robot in patients with PC.
Currently, there are no studies conducted that report the effectiveness of interventions performed with robotic walking training device Walkbot K on PC. However, studies in adults with Walkbot S, affected with neurological injury, have reported good results.
Assisted gait training with robotic devices such as the Walkbot, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions. However, due to the little evidence that exists, it is necessary to know the effectiveness of the Walkbot assisted walking robot in these patients by means of a clinical trial that allows to firmly establish the scope of its benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral palsy diagnosis (diplegia or tetraplegia)
- •Ability to communicate even if not verbal (yes/not; gestures; pictograms; sounds)
- •Levels II, III and IV in GMFCS
- •Unsupported seating capacity
- •Go on standing with or without help
- •Not receiving therapy with a walking robot and not having received it in at least one year
排除标准
- •Serious psychiatric problems
- •Serious heart problems
- •Active tumors
- •Severe joint degenerative problems
- •Degenerative diseases of the nervous system
- •Mitochondrial diseases
- •Recent surgeries
- •Unbound fractures
- •Severe osteoporosis
- •Uncontrolled seizures
- •Open wounds in the lower half of the body
- •Extreme fear of being placed in robotic devices
- •Anthropomorphic measures are below the minimum required to use the device
结局指标
主要结局
Ability and quality of walking.
时间窗: Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention
Changes in Gross Motor Function Measure-88 (dimensions IV y V)
次要结局
- Muscle strength(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
- Functionality and autonomy(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
- Quality of walking: Edinburgh Visual Gait Scale(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
- Range of motion(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
- Spasticity(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
- Gait endurance(Baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention)
研究者
Raquel Olmos Gómez
Principal investigator
Universidad de Murcia