An interventional study of Hyperbaric oxygen therapy and Conventional rehabilitation in Hyperbaric Oxygen Therapy, Neuroprotective and Pediatric, sponsored by Kafrelsheikh University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
This study aimed to assess the efficacy of hyperbaric oxygen therapy as a neuroprotective intervention in children with acquired brain injury.
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.
2,114 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.
This study's enrollment of 120 is above the median of 48 across 1,332 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindications to hyperbaric oxygen therapy :
Patients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation.
Other: Hyperbaric oxygen therapy
Patients received conventional rehabilitation alone.
Other: Conventional rehabilitation
Patients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation.
Patients received conventional rehabilitation alone.
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.
Time frame: Eight months post-intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Eight months post-intervention
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Kafrelsheikh University