Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury

Обзор

The goal of this clinical trial is to analyze the usability and safety of the robotic gait ATLAS 2030 in a cohort of pediatric patients with Spinal Cord Injury, with the aim of extending its indication for use to pediatric spinal cord injury

Подробное описание

Spinal cord injury has a relatively low prevalence in the pediatric population, although its effects have significant physical and psychological consequences that greatly impact the quality of life of affected children. The ATLAS 2030 exoskeleton is a robotic gait device approved by the Spanish Agency of Medicines and Medical Devices for the rehabilitation of pediatric patients with cerebral palsy and spinal muscular atrophy. The principal aim is to analyze the safety and usability of the ATLAS 2030 exoskeleton during the implementation of a robotic gait training program with this device in a cohort of pediatric patients with spinal cord injury. the secondary aim is to analyze, in the same cohort of pediatric patients with spinal cord injury and through the implementation of the same therapeutic program, the efficacy of the ATLAS 2030 exoskeleton in improving fatigability, mood, health perception, and gait speed.

Ten sessions with the ATLAS 2030 exoskeleton will be conducted with pediatric patients with acute or chronic spinal cord injury. Additionally, two assessment sessions will be performed before and after the series of sessions.

Вмешательства

• Устройство Rehabilitation treatment with ATLAS2030
  10 sessions of Rehabilitation Treatment with ATLAS2030 with With an evaluation session before the first session and another one after 10 sessions.

Первичные конечные точки

• Serious Adverse Events [Срок оценки: From enrollment to the last assessment session at 8 weeks]
• Falls prevalence [Срок оценки: From enrollment to the last assessment session at 8 weeks]
• Skin integrity [Срок оценки: From enrollment to the last assessment session at 8 weeks]
• Pain assessment [Срок оценки: From enrollment to the last assessment session at 8 weeks]
• Heart rate [Срок оценки: from the beginning to the end of treatment at 6 weeks]
• Oxygen saturation [Срок оценки: from the beginning to the end of treatment at 6 weeks]
• Blood pressure [Срок оценки: from the beginning to the end of treatment at 6 weeks]
• User and/or caregiver perception of the device [Срок оценки: From enrollment to the last assessment session at 8 weeks]
• Device usage data [Срок оценки: From enrollment to the last assessment session at 8 weeks]
• Number of steps [Срок оценки: From enrollment to the last assessment session at 8 weeks]

Вторичные конечные точки (5)

• State of mind [Срок оценки: from the beginning to the end of treatment at 6 weeks]
• Health perception [Срок оценки: from enrollment to the last assessment session at 8 weeks]
• Health perception [Срок оценки: from enrollment to the last assessment session at 8 weeks]
• 10 Meter Walking Test (10 MWT) measured with ATLAS 2030 [Срок оценки: From enrollment to the last assessment session at 8 weeks]
• Effort perception [Срок оценки: from the beginning to the end of treatment at 6 weeks]

Критерии участия

Критерии включения

• Having a subacute or chronic spinal cord injury (SCI) and being clinically stable with a general condition good enough to participate in the therapeutic program with the ATLAS 2030.
• Age between 3 and 14 years.
• Medical authorization to perform standing and gait training with weight-bearing.
• Consent from the participant or legal guardian to participate in the study.
• Adequate level of acceptance and commitment from the family.

Inclusion criteria related to device characteristics:

• Weight ≤ 35 kg.
• Hip width ≤ 34 cm. It is advised that for measurements under 28 cm, verification should be performed to ensure there is no excessive base of support that might induce foot inversion in the standing position.
• Femur length (distance from the greater trochanter to the lateral condyle of the femur) between 24 cm and 33 cm. Femur lengths shorter than 24 cm are acceptable as long as the hip motor of the device does not extend above the user's iliac crest, avoiding hypermobility of the lumbar spine.
• Tibia length (distance from the lateral condyle to the lateral malleolus of the tibia) between 23 cm and 32 cm. Tibia lengths shorter than 23 cm are acceptable as long as they can be compensated with a lift and the user's ankle joint remains within the area of the ankle motor.
• EU shoe size between 27 and 33.

Критерии исключения

• Impossibility for the family to complete treatment schedule planning.
• Any contraindication for standing and/or walking.
• Spasticity (Modified Ashworth Scale (MAS) = 4 in the lower limbs at the time of device use).
• Joint contracture of the hip and/or knee > 20 degrees.
• Need to walk with more than 9 degrees of hip abduction.
• Need to walk with more than 9 degrees of dorsal or plantar ankle flexion, or inability to use an orthosis to achieve 90° at the ankle.
• Severe skin lesions in areas of contact with the device.
• Planned surgical intervention during the study period or previous orthopedic surgery on the spine and/or lower limbs contraindicating treatment.
• Known advanced osteoporosis evidenced by bone densitometry, particularly with a history of prior fractures or fractures without trauma. Traumatic bone fractures in the lower limbs or pelvic girdle within the past 6 months.
• Unstable fractures, joint dislocations, or other joint pathologies in the trunk and lower limbs contraindicating the treatment.
• Severe rigid orthopedic deformities of the spine that prevent the use of the device.
• Presence of frequent seizures, uncontrolled epilepsy, or difficult-to-control behavioral disorders.
• Presence of decompensated heart or lung disease, or any other condition causing exercise intolerance.
• Allergy to any of the materials used in the ATLAS 2030: cotton, nylon, polyester, polyamide, polyethylene, or polypropylene.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Nacional Parapléjicos — Toledo

Идентификаторы

NCT: NCT06772077 · ATLAS-LM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗