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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury; Pediatric; Hyperbaric Oxygen Therapy; Neuroprotective; Motor Disability
• Intervention / Treatment: Other: Hyperbaric oxygen therapy; Other: Conventional rehabilitation

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperbaric oxygen therapy group; Patients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation.	Other: Hyperbaric oxygen therapy; Patients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation.
Active Comparator: Control group; Patients received conventional rehabilitation alone.	Other: Conventional rehabilitation; Patients received conventional rehabilitation alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity assessment	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.	Eight months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate changes in gross motor function temporally	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.	Eight months post-intervention
Upper limb function assessment	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.	Eight months post-intervention
Assessment the fine motor function progression	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.	Eight months post-intervention
Evaluate feeding capabilities	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.	Eight months post-intervention

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries
• Other Study ID Numbers: KFSIRB200-137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No