Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Serious Adverse Events
研究概览
简要总结
The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.
详细描述
Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to analyze the safety and usability of the EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
A test phase will be conducted in order to make some final modifications and improve the device. Some participants of the sample will use the device in 1-3 occasions in a controlled environment.
After these modifications, participants will use the final version of the device in 8 different occasions in their homes and the community in order to prove its safety and usability.
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
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy, acquired brain injury or spinal muscular atrophy
- •Medical authorization for standing, gait training and weight bearing.
- •Informed consent signed by legal guardians.
- •Maximum user weight of 60 kg.
- •Hip width (between greater trochanters) ≤40 cm.
- •Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 21cm to 36cm.
- •Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 20cm to 35cm.
- •Shoe size ≤40 (EU)
排除标准
- •Medical contraindications for standing or walking.
- •Non-reducible contractures or heterotropic ossifications above the degrees allowed by the device or out of the trajectory imposed by the device
- •Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
- •More than 20º of hip and/or knee non-reducible contractures at the time of using the exoskeleton.
- •Necessity to walk with more than 5º of hip abduction.
- •Impossibility to reach 5º of ankle dorsiflexion with ir without orthoses.
- •Lower length dysmetria that cannot be mitigated with a wedge under the foot.
- •Skin lesion on parts of the lower extremities that are in contact with the device.
- •History of fracture without trauma.
- •Presence of other conditions causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease).
- •Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness.
- •Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.
结局指标
主要结局
Serious Adverse Events
时间窗: through study completion, along 8 weeks
occurrence of any serious adverse event to the participant or the caregiver
Falls prevalence
时间窗: through study completion, along 8 weeks
Number of falling events occurred from the participant or caregiver
Oxygen saturation
时间窗: through study completion, along 8 weeks
measurement of Oxygen saturation when medical prescription
Skin integrity
时间窗: through study completion, along 8 weeks
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Pain (Visual Analogic Scale)
时间窗: through study completion, along 8 weeks
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"
Heart rate
时间窗: through study completion, along 8 weeks
measurement of heart rate
Spasticity
时间窗: through study completion, along 8 weeks
spasticity measured by the Modified Ashworth Scale (MAS), scored from 0 (no spasticity) to 4 (affected part in rigid flexion or extension)
Donning and doffing time
时间窗: through study completion, along 8 weeks
Time to don and doff the device to each participant
Walking time
时间窗: through study completion, along 8 weeks
Walking time provided by the device
Blood pressure
时间窗: through study completion, along 8 weeks
measurement of blood pressure
Number of steps
时间窗: through study completion, along 8 weeks
Number of steps taken provided by the device
Interventions of the investigators
时间窗: through study completion, along 8 weeks
The number of times that the investigators have to intervene in the session in order to avoid damage when the device is being used by the caregiver
Participant satisfaction
时间窗: at the end of the intervention, 8th week
Satisfaction of the participant (caregiver) with the device measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0. (QUEST 2.0), scored with a Likert type scale from 0 to 5, being 0 the lowest satisfaction and 5 the highest possible satisfaction with the device
次要结局
- Acceptability(at the end of the intervention, 8th week)
- Accessibility of the exterior spaces(through study completion, along 8 weeks)
- Accessibility of the house(through study completion, along 8 weeks)
- Accessibility of the participant(through study completion, along 8 weeks)