Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Falls prevalence
研究概览
简要总结
The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.
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. Exoskeletons are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER V2 is a prototype of a robotic gait exoskeleton 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 V2 as a proof of concept.
A test phase will be conducted in healthy volunteers (phase 0) as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in children with neurological and neuromuscular disease (phases 1 and 2). After this, participants will use the exoskeleton in 4 different ocassions, 1 in a laboratory of gait analysis and 3 in their homes and the community.
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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical authorization for standing, gait training and weight bearing.
- •Informed consent signed by legal guardians.
- •Maximum user weight of 35 kg.
- •Hip width (between greater trochanteres) ≤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 ≤38 (EU)
排除标准
- •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 flessum at the time of using the exoskeleton.
- •Necessity to walk with 15 of hip abduction.
- •Skin lesion on parts of the lower extremities that are in contact with the device.
- •Scheduled surgery scheduled during the study period.
- •History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
- •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 or the inability to understand simple comands.
- •Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.
结局指标
主要结局
Falls prevalence
时间窗: through study completion, along 6 weeks
Number of falling events ocurred from the participant or caregiver
Skin integrity
时间窗: through study completion, along 6 weeks
Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton
Blood pressure
时间窗: through study completion, along 6 weeks
measurement of blood pressure when medical prescription
Oxygen saturation
时间窗: through study completion, along 6 weeks
measurement of Oxygen saturation when medical prescription
Interventions of the investigators
时间窗: through study completion, along 6 weeks
The amount 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
Pain (Visual Analogic Scale)
时间窗: through study completion, along 6 weeks
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver
Spasticity
时间窗: through study completion, along 6 weeks
spasticity measured by the Modified Ashworth Scale (MAS)
Kinematic data during gait
时间窗: Once, during the first session with the exoskeleton
Kinematic values for each joint of the lower limb during gait, assessed by photogrammetry in a gait analysis laboratory both in healthy subjects and participants with disease
Heart rate
时间窗: through study completion, along 6 weeks
measurement of heart rate when medical prescription
Serious Adverse Events
时间窗: through study completion, along 6 weeks
occurrence of any serious adverse event to the participant or the caregiver
Participant satisfaction
时间窗: at the end of the intervention, 6th week
Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0.
Number of steps
时间窗: through study completion, along 6 weeks
Number of steps taken with the exoskeleton provided by the device
Walking time
时间窗: through study completion, along 6 weeks
Walking time while using the exoskeleton provided by the device
Donning and doffing time
时间窗: through study completion, along 6 weeks
Time to don and doff the device to each participant
次要结局
- Accesssibility of the participant(through study completion, along 6 weeks)
- Accesssibility of the house(through study completion, along 6 weeks)
- Accesssibility of the exterior spaces(through study completion, along 6 weeks)
- Acceptability(At the end of the study, 6th week)