Hyperbaric Oxygen TherapyNCT06954389
Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability
A study testing Hyperbaric oxygen therapy and Conventional rehabilitation in people with Hyperbaric Oxygen Therapy and Neuroprotective, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aimed to assess the efficacy of hyperbaric oxygen therapy as a neuroprotective intervention in children with acquired brain injury. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Hyperbaric Oxygen Therapy, Neuroprotective, Pediatric
- What is being tested?
- Hyperbaric oxygen therapy and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Positive family history of degenerative brain insults.
- Behavioral problems.
- Contraindications to hyperbaric oxygen therapy :
- Active epilepsy.
- Respiratory insufficiency.
- Uncontrolled heart failure.
Show all 9Show fewer
- Eustachian tube dysfunction.
- Tympanic membrane rupture.
- Mechanical ventilation dependency.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to assess the efficacy of hyperbaric oxygen therapy as a neuroprotective intervention in children with acquired brain injury.
Read the 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.
- Conditions
- Hyperbaric Oxygen Therapy, Neuroprotective, Pediatric, Acquired Brain Injury, Motor Disability
- Being tested
- Hyperbaric oxygen therapy, Conventional rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyOther
Patients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation.
Conventional rehabilitationOther
Patients received conventional rehabilitation alone.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy group | Experimental | Patients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation. Receives: Other: Hyperbaric oxygen therapy |
| Control group | Active comparator | Patients received conventional rehabilitation alone. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eight months post-intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Eight months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Mar 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbaric Oxygen TherapyStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohammed Abdel Hamid Gaml, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954389
- Sponsor's protocol ID
- KFSIRB200-137
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability
- ClinicalTrials.gov ID
- NCT06954389
- Acronym / sponsor ID
- KFSIRB200-137
- Conditions
- Hyperbaric Oxygen Therapy, Neuroprotective, Pediatric, Acquired Brain Injury, Motor Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy group | Experimental | Other: Hyperbaric oxygen therapyPatients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation. |
| Control group | Active comparator | Other: Conventional rehabilitationPatients received conventional rehabilitation alone. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- Positive family history of degenerative brain insults.
- Behavioral problems.
- Contraindications to hyperbaric oxygen therapy :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyPatients received hyperbaric oxygen therapy using a monochamber hyperbaric chamber in addition to conventional rehabilitation. | Other | Hyperbaric oxygen therapy group |
| Conventional rehabilitationPatients received conventional rehabilitation alone. | Other | Control group |
Primary outcome
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.
4 secondary outcomes
Evaluate changes in gross motor function temporally
Time frame: Eight months post-intervention
Upper limb function assessment
Time frame: Eight months post-intervention
Assessment the fine motor function progression
Time frame: Eight months post-intervention
Evaluate feeding capabilities
Time frame: Eight months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy and Conventional rehabilitation in people with Hyperbaric Oxygen Therapy and Neuroprotective, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity assessment (time frame: Eight months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.