Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Spasticity assessment
研究概览
简要总结
This study aimed to assess the efficacy of hyperbaric oxygen therapy as a neuroprotective intervention in children with acquired brain injury.
详细描述
Pediatric acquired brain injury (ABI) represents a significant challenge in modern medicine, necessitating innovative therapeutic approaches to enhance recovery and minimize long-term neurological deficits.
Hyperbaric oxygen therapy (HBOT), which delivers oxygen at pressures exceeding atmospheric levels, has emerged as a promising neuroprotective intervention for various forms of pediatric brain injury, including traumatic brain injury (TBI), anoxic-ischaemic encephalopathy (AIE), and stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-12 years.
- •Diagnosed with pediatric acquired brain injury confirmed by neurological examination and magnetic resonance imaging.
- •Presence of neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infection, stroke, tumor, hypoxia).
排除标准
- •Positive family history of degenerative brain insults.
- •Behavioral problems.
- •Contraindications to hyperbaric oxygen therapy :
- •Active epilepsy.
- •Respiratory insufficiency.
- •Uncontrolled heart failure.
- •Eustachian tube dysfunction.
- •Tympanic membrane rupture.
- •Mechanical ventilation dependency.
研究组 & 干预措施
Control group
Patients received conventional rehabilitation alone.
干预措施: Conventional rehabilitation (Other)
Hyperbaric oxygen therapy group
Patients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation.
干预措施: Hyperbaric oxygen therapy (Other)
结局指标
主要结局
Spasticity assessment
时间窗: Eight months post-intervention
Spasticity assessment was conducted utilizing the Modified Ashworth Scale (MAS), which quantified resistance during passive soft tissue stretching. * Grade 0: No increase in muscle tone. * Grade 1: Slight increase in tone, minimal resistance. * Grade 2: More marked increase, resistance through most ROM. * Grade 3: Considerable increase, passive movement difficult. * Grade 4: Rigidity in flexion/extension. * Grade 5: Rigidity preventing passive movement.
次要结局
- Evaluate changes in gross motor function temporally(Eight months post-intervention)
- Upper limb function assessment(Eight months post-intervention)
- Assessment the fine motor function progression(Eight months post-intervention)
- Evaluate feeding capabilities(Eight months post-intervention)
研究者
Eman Mohammed Abdel Hamid Gaml
Assistant Lecturer of Pediatrics, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.
Kafrelsheikh University