Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.

Обзор

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 .

Подробное описание

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.

Вмешательства

• Устройство CLINICAL EXPLORER
  8 sessions of use of the device in the rehabilitation center

Первичные конечные точки

• Serious Adverse Events [Срок оценки: through study completion, along 8 weeks]
• Falls prevalence [Срок оценки: through study completion, along 8 weeks]
• Skin integrity [Срок оценки: through study completion, along 8 weeks]
• Pain (Visual Analogic Scale) [Срок оценки: through study completion, along 8 weeks]
• Heart rate [Срок оценки: through study completion, along 8 weeks]
• Oxygen saturation [Срок оценки: through study completion, along 8 weeks]
• Blood pressure [Срок оценки: through study completion, along 8 weeks]
• Donning and doffing time [Срок оценки: through study completion, along 8 weeks]
• QUEST [Срок оценки: at the end of the intervention at 8 weeks]

Вторичные конечные точки (9)

• Gait analysis [Срок оценки: Day 1 and at the end of the intervention at 8 weeks]
• Range of motion [Срок оценки: Day 1 and at the end of the intervention at 8 weeks]
• Quality of life (EQ-5D) [Срок оценки: Day 1 and at the end of the intervention at 8 weeks]
• Level of fatigue [Срок оценки: through study completion, along 8 weeks]
• Level of Spasticity [Срок оценки: Day 1 and through study completion, along 8 weeks]
• Muscular activity (EMG) [Срок оценки: through study completion, along 8 weeks]
• Cerebral activity (EEG) [Срок оценки: through study completion, along 8 weeks]
• Acceptability [Срок оценки: at the end of the intervention, 8th week]
• Accessibility of the participant [Срок оценки: through study completion, along 8 weeks]

Критерии участия

Inclusion Criteria 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Asociación Pro Personas con Paralisis Cerebral (APAC-IAP) — Mexico City

Испания · 1 центр

• Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia — Madrid

Идентификаторы

NCT: NCT07159360 · EXC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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