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

Not Applicable

Completed

• Conditions: Hyperbaric Oxygen Therapy; Neuroprotective; Pediatric; Acquired Brain Injury; Motor Disability

• Registration Number: NCT06954389
• Lead Sponsor: Kafrelsheikh University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Spasticity assessment	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 Outcome Measures

Name	Time	Method
Evaluate changes in gross motor function temporally	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.
Upper limb function assessment	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.
Assessment the fine motor function progression	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.
Evaluate feeding capabilities	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.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt