Post-market Study to Demonstrate the Safety and Performance of an Extension Assist Knee Ankle Foot Orthosis (Agilik) to Improve Gait in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- change of range of motion of the knee overground
研究概览
简要总结
The purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot orthosis (KAFO), or EA-KAFO, in individuals with knee extension deficiency due to cerebral palsy (CP). The EA-KAFO tested in this investigation, whose commercial name is Agilik™, is registered as a Class 1 medical device in the European (EU) Medical Device Regulation (MDR) and with the United States (US) Food and Drugs Administration (FDA). The study will take place in Astrolab at the Istituto Scientifico E. MEDEA - La Nostra Famiglia (IRCCS Medea hereafter). The duration of the investigation will be 36 months. The duration of the study for a single subject will be approximately 10 weeks.
The primary purpose of this study is to demonstrate the safety and performance of a powered extension assist knee ankle foot orthosis (Agilik) in individuals with knee extension deficiency due to cerebral palsy. The focus is on the improvement of anti-gravity knee extension during stance in patients with CP with crouch gait. Therefore, the primary aim is to compare the knee and range of motion (ROM) at baseline and after 10 sessions of Agilik training while wearing Agilik itself. Secondary aim is to compare knee ROM before and after the training with Agilik without wearing Agilik.
The changes in lower extremity functions, kinematics and muscle activity during walking with Agilik compared to baseline conditions will be examined. Furthermore, the performance of Agilik during uphill and downhill walking over the GRAIL platform will be investigated.
Hypotheses when using Agilik:
- Improve knee extension during stance and swing gait phases
- Increase step length, walking distance and speed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •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.
- •Age between 5 and 17
- •Maximum weight of 70 Kg
- •Volunteer who have a gait pathology involving the knee joint, from a diagnosis of CP
- •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 10° 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 history and physical examination.
- •GMFCS level I, II and III
- •MAS score ≤ 2
排除标准
- •Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time.
- •A history of uncontrolled seizure in the past year
- •Severe spasticity
研究组 & 干预措施
GroupA_Agilik first
This arm will be assessed at T0, then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and will perform T1 evaluations, and then it will repeat the evaluations after other 5 weeks (T2) during which they performed they standard care
干预措施: Agilik (Device)
GroupA_Agilik first
This arm will be assessed at T0, then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and will perform T1 evaluations, and then it will repeat the evaluations after other 5 weeks (T2) during which they performed they standard care
干预措施: standard care (Other)
GroupB_standard care first
This arm will be assessed at T0, then it will continue with their standard care and will perform T1 evaluation after 5 weeks, and then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and the final evaluation (T2)
干预措施: Agilik (Device)
GroupB_standard care first
This arm will be assessed at T0, then it will continue with their standard care and will perform T1 evaluation after 5 weeks, and then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and the final evaluation (T2)
干预措施: standard care (Other)
结局指标
主要结局
change of range of motion of the knee overground
时间窗: 6 weeks
the range of motion of the knee will be measured by means of BTS Bioengineering S.p.A. optoelectronic system during the overground gait analysis assessment with Agilik
change in gait speed
时间窗: 6 weeks
the gait speed will be measured by means of the 10 meters walking test (10mWT) with Agilik
satisfaction using Agilik
时间窗: 6 weeks
the children's satisfaction with Agilik will be evaluated with the Quebec User Evaluation of Satisfaction adapted to children (QUEST 2.1).
change of range of motion of the knee uphill/downhill
时间窗: 6 weeks
the range of motion of the knee will be measured by means of the GRAILoptoelectronic system that is equipped with a motion platform and that will simulate uphill and downhill walking while performing gait analysis assessment with Agilik
change in centre of mass oscillations
时间窗: 6 weeks
Centre of mass (COM) oscillations will be measured during 1 minute of standing by means of the G-Sensor, a wearable three axial accelerometer and gyroscope
change in endurance
时间窗: 6 weeks
The endurance will be measured by means of the 6 minute walking test (6MWT) with Agilik
change in spasticity
时间窗: 6 weeks
The level of spasticity in the lower limbs will be measured by means of the Ashworth scale (MAS level, Modified Ashworth scale level) with Agilik
change in muscle lengths
时间窗: 6 weeks
Joint and muscle lengths examination will be performed manually
change in centre of pressure oscillations
时间窗: 6 weeks
Centre of pressure (COP) oscillations will be assessed by means of the force plates embedded in the GRAIL system, during 1 minute of still standing
次要结局
- change in centre of pressure oscillations without Agilik(6 weeks)
- change of range of motion of the knee overground without Agilik(6 weeks)
- change of range of motion of the knee uphill/downhill without Agilik(6 weeks)
- change in endurance without Agilik(6 weeks)
- change in gait speed without Agilik(6 weeks)
- change in centre of mass oscillations without Agilik(6 weeks)