Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury.
Acquired brain injury (ABI) from primary neurologic diagnoses accounts for 20% of all pediatric critical care admissions and more than 60,000 hospital admissions annually.
Ozone (O3) gas was discovered in the 1840s, and soon after that, the scientific community began to expand past the notion that it was just another gas of the Earth's atmosphere.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program. |
|
| Group 2 | Active Comparator | Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal ozone sessions | Other | Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of muscle Tone | Assessment of muscle tone (degree of spasticity) of affected child according to Modified Ashworth's Scale. Ashworth's scale is a 6-point scale, from 0 to 4, with higher scores indicating greater spasticity. | 6 months post-sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of reduction in neuroinflammation | Incidence of reduction in neuroinflammation will be recorded. | 6 months post-sessions |
| Assessment of quality of life | Assessment of quality of life including emotional well-being or social interaction will be recorded. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M Asfour, Master | Contact | 00201017440223 | drahmedasfour14@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar University | Recruiting | Cairo | 11651 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional rehabilitation program | Other | Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months). |
|
| 6 months post-sessions |
| Incidence of adverse effects | Incidence of adverse effects will be recorded. | 6 months post-sessions |
| Measurement of age-related response variability | Age-related response variability by evaluating how different age groups respond to treatment will be recorded. | 6 months post-sessions |