Soft Robotics for Improved Standing and Walking in Infants With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gross Motor Function Classification System
研究概览
简要总结
Children with spastic cerebral palsy suffer from significant weakness that contributes to abnormal posture and movement. It is thought that this arises due lack of frequency sufficient tension to encourage normal muscular growth underlying the need for early intervention to encourage walking. The failure of muscle growth to keep pace with bone growth is most evident in the bi-articular muscles and contributes to joint contractures and gait abnormalities such as toe-walking and flexed-knee gait.
Recently, our research team has developed a novel, lightweight (0.2kg at knee joint) and portable (energetically autonomous) Soft Wearable Robotic Knee System that can provide active powered knee assistance and synchronized proprioceptive feedback for the gait training of stroke patients' standing and walking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •capable of understanding the proposed exercises;
- •aged 2 to 15 years;
- •maximum weight 75 kg;
- •children with no deformations that could prevent the use of the exoskeleton;
- •Gross Motor Function Classification System (GMFCS) levels I to III;
- •able to signal pain or discomfort.
排除标准
- •unhealed skin lesions in the lower limbs;
- •aggressive or self-harming behaviors;
- •severe cognitive impairment.
结局指标
主要结局
Gross Motor Function Classification System
时间窗: Within one month after the last training session
It categorized the gross motor function of children and young people with cerebral palsy into 5 different levels. With level 1: Children walk at home, school, outdoors and in the community, while level 5: Children are transported in a manual wheelchair in all settings.
次要结局
- Five Times Sit to Stand Test(Within one month after the last training session)
- 6-Minute-Walk Test(Within one month after the last training session)
- Berg Balance Scale(Within one month after the last training session)
- 10-Meter-Walk Test(Within one month after the last training session)
- Timed Up and Go test(Within one month after the last training session)
研究者
Raymond KY Tong
Professor and Chairman
Chinese University of Hong Kong