Evaluation of Outcomes Related to Walking in a Rehabilitation Program Supported by Robotics (Lokomat) in Children Suffering From Congenital and Acquired Brain Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Effectiveness of the rehabilitation program in terms of gait speed
研究概览
简要总结
The use of robotic devices in rehabilitation programs can improve walking patterns by reorganizing joint kinematics. This study aims to quantify the effects of a rehabilitation program supported by the Lokomat (Hocoma) robotic device on walking in children and young people with movement disorders, considering different levels of impairment.
详细描述
Cerebral Palsy is one of the most common neuromotor disorders in pediatric age, characterized by permanent movement and posture impairments, often affecting walking. In recent decades, advancements in robotics have revolutionized rehabilitation. Studies have shown that combining conventional physiotherapy with robotic rehabilitation tools offers greater benefits in patient recovery. At the IRCCS Eugenio Medea, a robotic rehabilitation program using the Lokomat (Hocoma) has been implemented for several years to improve walking in children and young people with walking disorders. The investigators hypothesize that robotic devices can enhance walking ability (e.g., speed, stride length) and reorganize joint kinematics. This study aims to quantify the effects of this treatment based on the level of impairment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of CP;
- •able to walk independently with or without assistance
排除标准
- •presence of behavioral problems;
- •presence of uncontrolled seizures
- •presence of severe visual disturbances.
结局指标
主要结局
Effectiveness of the rehabilitation program in terms of gait speed
时间窗: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the walking speed \[m\\s\] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Effectiveness of the rehabilitation program in terms of cadence
时间窗: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the walking cadence \[step/min\] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Effectiveness of the rehabilitation program in terms of stride length
时间窗: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the stride length \[mm\] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Effectiveness of the rehabilitation program in terms of step width
时间窗: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the step width \[mm\] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Effectiveness of the rehabilitation program in terms of gait phase
时间窗: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the gait phase \[cycle%\] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Effectiveness of the rehabilitation program in terms of lower limbs ROM
时间窗: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the lower limbs ROM \[°\] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Effectiveness of the rehabilitation program in terms of summary gait parameters GDI
时间窗: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the summary gait parameter Gait Deviation Index (GDI) will be calculated. A GDI of 100 or higher indicates the absence of gait pathology. Moreover, the pre- and post-treatment results will be compared for each subject.
Effectiveness of the rehabilitation program in terms of summary gait parameters GPS
时间窗: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the summary gait parameter Gait Profile score (GPS)\[°\] will be calculated. A GPS of 7 or lower indicates the absence of gait pathology. Moreover, the pre- and post-treatment results will be compared for each subject.
次要结局
- Treatment effect based on the level of impairment about walk fatique(Through study completion, an average of 1 year)
- Treatment effect based on the level of impairment about gross motor ability(Through study completion, an average of 1 year)
- Treatment effect based on the level of impairment about functional activity(Through study completion, an average of 1 year)