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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06954389
Enrollment
120
Registered
2025-05-01
Start date
2024-03-01
Completion date
2024-10-01
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Hyperbaric Oxygen Therapy, Motor Disability, Neuroprotective, Pediatric

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.

Interventions

OTHERHyperbaric oxygen therapy

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

OTHERConventional rehabilitation

Patients received conventional rehabilitation alone.

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Spasticity assessmentEight months post-interventionSpasticity 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

MeasureTime frameDescription
Evaluate changes in gross motor function temporallyEight months post-interventionThe 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 assessmentEight months post-interventionUpper 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 progressionEight months post-interventionThe 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 capabilitiesEight months post-interventionThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026