Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Serious Adverse Events
研究概览
简要总结
Neurodevelopmental disorders often result in abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as the inability to stand and walk. CLINICAL EXPLORER is a clinical-use robotic device for gait training, representing the evolution of the ATLAS 2030 exoskeleton and the EXPLORER device for home use. The aim of this study is to evaluate the safety and usability of CLINICAL EXPLORER .
详细描述
Neuromuscular and neurological disorders in children cause muscle weakness and spasticity, leading to severe motor dysfunctions such as the inability to maintain posture or walk. Manually assisted gait training can be physically demanding for therapists, which is why robotic devices have been developed to reduce their workload, provide objective assessments through integrated sensors, and improve rehabilitation quality. Beyond mobilizing muscles and joints, these devices enhance brain neuroplasticity and the child's connectivity with their environment, positively impacting self-esteem and social interaction. A clinical-use robotic device for gait training has been developed, representing the evolution of the ATLAS 2030 exoskeleton and the EXPLORER device for home use.
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
- 是
入选标准
- •for Phase 0
- •Age between 2 and 17 years.
- •Consent from the participant or legal guardian to participate in the study.
- •No diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria for Phase 1
- •Age between 2 and 17 years.
- •Consent from the participant or legal guardian to participate in the study.
- •Diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria Related to the EXPLORER CLINICAL Device Characteristics
- •Medical authorization to stand upright and perform weight-bearing gait training.
- •Weight less than or equal to 60 kg.
- •Hip width less than or equal to 40 cm.
- •Distance from the hip joint center to the knee joint center: 21 cm - 36 cm.
- •Distance from the knee joint center to the ankle joint center: 20 - 35 cm.
- •EU shoe size less than or equal to 40.
排除标准
- •Any medical contraindication for standing or walking.
- •Presence of non-reducible contractures or heterotopic ossification above the degrees allowed by the device and/or outside the trajectory imposed by the device.
- •Spasticity (MAS) = 4 in lower limbs at the time of device use.
- •Structured hip and/or knee contracture greater than 20 degrees.
- •Inability to stand or walk with more than 5 degrees of hip abduction.
- •Inability to achieve 5 degrees of dorsal ankle flexion from the neutral position with or without orthosis.
- •Tibial leg length discrepancy that cannot be mitigated with the use of a foot wedge.
- •Skin alterations in areas of contact with the device.
- •History of fracture without trauma.
- •Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe pulmonary disease).
- •Behavioral disorders that interfere with proper use of the device, such as impulsivity.
- •Allergy to any of the materials of the EXPLORER CLÍNICO: cotton, nylon, polyester, PPS, PEEK, or ABS. The materials used in EXPLORER CLÍNICO that were not previously used in ATLAS 2030, a medical device certified by the AEMPS, are PPS, PEEK, and ABS.
研究组 & 干预措施
CLINICAL EXPLORER
An initial assessment (screening visit), 8 intervention sessions (2 per week) in the rehabilitation center, and a final assessment.
干预措施: CLINICAL EXPLORER (Device)
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
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 with a smart band
Oxygen saturation
时间窗: through study completion, along 8 weeks
measurement of Oxygen saturation with a smart band
Blood pressure
时间窗: through study completion, along 8 weeks
measurement of blood pressure with a smart band
Donning and doffing time
时间窗: through study completion, along 8 weeks
Time to don and doff the device to each participant
QUEST
时间窗: at the end of the intervention at 8 weeks
Using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire administered to the participants' caregivers at the end of the intervention. The QUEST 2.0 scale has 12 items. Each item is rated on a 5-point Likert scale
次要结局
- Gait analysis(Day 1 and at the end of the intervention at 8 weeks)
- Range of motion(Day 1 and at the end of the intervention at 8 weeks)
- Quality of life (EQ-5D)(Day 1 and at the end of the intervention at 8 weeks)
- Level of fatigue(through study completion, along 8 weeks)
- Level of Spasticity(Day 1 and through study completion, along 8 weeks)
- Muscular activity (EMG)(through study completion, along 8 weeks)
- Cerebral activity (EEG)(through study completion, along 8 weeks)
- Acceptability(at the end of the intervention, 8th week)
- Accessibility of the participant(through study completion, along 8 weeks)