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NCT Number: NCT06954389

Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability

This study aimed to assess the efficacy of hyperbaric oxygen therapy as a neuroprotective intervention in children with acquired brain injury.

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Key information

Conditions

Hyperbaric Oxygen Therapy Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Motor Disability Nervous System Diseases Neuroprotective Pediatric Trauma, Nervous System Wounds and Injuries

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Hyperbaric Oxygen Therapy

Other

Patients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation.

conventional rehabilitation

Other

Patients received conventional rehabilitation alone.

Primary outcomes

  1. Spasticity assessment

    Time frame: 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.

Secondary outcomes

  1. Evaluate changes in gross motor function temporally

    Time frame: Eight months post-intervention

    The Gross Motor Function Measure (GMFM) was utilized to evaluate changes in gross motor function temporally. This standardized assessment specifically quantified task completion capability rather than qualitative performance metrics.

    • Level I: Independent ambulation without limitations.
    • Level II: Walks without assistance but with limitations (e.g., uses handrails).
    • Level III: Walks with assistive devices (e.g., walker).
    • Level IV: Non-ambulatory but can move independently on hands and knees.
    • Level V: Complete dependence on a manual wheelchair for mobility.

  2. Upper limb function assessment

    Time frame: Eight months post-intervention

    Upper limb function assessment (ULFA) was evaluated utilizing the Gordon and Duff Scale, which employed a six-point classification system (Types 0-5).

    • Type 0: No active upper extremity function.
    • Type 1: Minimal active movement, no functional use.
    • Type 2: Partial grasp and release, limited thumb opposition.
    • Type 3: Functional grasp but impaired precision tasks.
    • Type 4: Normal function with slight limitations (e.g., reduced speed).
    • Type 5: Normal or near-normal function with entire thumb opposition.

  3. Assessment the fine motor function progression

    Time frame: Eight months post-intervention

    The Manual Ability Classification System (MACS) was implemented to assess fine motor function progression.

    • Level I: Handles objects easily and successfully.
    • Level II: Handles most objects with minor adaptations.
    • Level III: Handles objects with difficulty and requires assistance.
    • Level IV: Handles very few objects, highly dependent.
    • Level V: Does not handle objects and requires full support.

  4. Evaluate feeding capabilities

    Time frame: Eight months post-intervention

    The Eating and Drinking Ability Classification System (EDACS) was employed to evaluate feeding capabilities.

    • Level I: Safe and efficient oral intake without assistance.
    • Level II: Minor dietary restrictions or compensatory strategies.
    • Level III: Moderate dietary restrictions and assistance.
    • Level IV: Requires alternative feeding methods (e.g., gastrostomy).
    • Level V: Complete dependence on non-oral feeding.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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