Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Endurance
研究概览
简要总结
The goal of this clinical trial is to learn if a two month training with the Agilik powered orthosis improves the knee extension or the endurance in pediatric patients with Cerebral palsy and a crouch gait. It will also learn about the safety of Agilik. The main questions it aims to answer are:
Does the Agilik powered orthosis increase the value of the knee extension during walking? What medical problems do participants have when using the Agilik powered orthosis? Researchers will compare a group of patients using the Agilik powered exoskeleton with a group of patients treated with standard therapy.
Participants will:
Use Agilik at home or perform standard therapy for 2 months Visit the clinic at the beginning of the study, after 3 months and after 1 additional month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CP and a crouch gait
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.
- •Body weight between 20 and 125 Kg
- •Knee flexion retraction assessed in supine position by less than 10°. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
- •Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 5° of passive dorsi-flexion of the ankle.
- •Able to walk at least 3 m without stopping, with or without a walking aid.
- •Able to understand and follow simple directions based on parent report and physician observation during historical and physical examination.
- •GMFCS level I, II and III
- •MAS score ≤ 2
排除标准
- •Any severe neurological, musculoskeletal and/or cardiorespiratory involvement preventing the ability to walk;
- •A history of uncontrolled seizure in the past year
- •Severe spasticity
- •Hip and/or knee flexion contracture of more than 20°
研究组 & 干预措施
Control Group
Intervention Arm
Home rehabilitation
干预措施: Powered orthosis (Device)
结局指标
主要结局
Endurance
时间窗: Baseline, 3 months and 4 months
Distance walked during a 6-minutes walking test (6MWT)
Knee extension in mid stance (KEMS)
时间窗: Baseline, 3 months and 4 months
Anti-gravity knee extension in mid stance measured with quantitative gait analysis
次要结局
- Self-perception of performance in everyday living(Baseline, 3 months and 4 months)
- Behavioural engagement(After the treatment only in the intervention group)
- Measurements of the Joint range of motions (ROMs) and muscle lengths(Baseline, 3 months and 4 months)
- Level of spasticity in the lower limbs(Baseline, 3 months and 4 months)
- Walking speed(Baseline, 3 months and 4 months)
- Postural and motor abilities(Baseline, 3 months and 4 months)
- Gait pattern(Baseline, 3 months and 4 months)
- Static balance(Baseline, 3 months and 4 months)
- Usability and acceptability of the powered orthosis(After the treatment only in the intervention group)