An Evaluation of the Therapeutic Effectiveness of Hyperbaric Oxygen Treatments and Hyperbaric Air Treatments for Children With Cerebral Palsy
Description:
The study proposed herein is a randomized, double blind study to evaluate the therapeutic
effectiveness of HBO in children (ages 3-8 years) with a diagnosis of spastic CP. Ninety-four
children will be randomly assigned to either a hyperbaric oxygen treatment group or
hyperbaric air treatment (HBA) group. Each group will receive 40 dives of 60 minutes duration
each at 1.5 atmospheres of pressure (ATA) (the HBO group receiving 100% oxygen, and the HBA
group receiving an air mixture containing 14% oxygen, which simulates 21% oxygen at 1.5 ATA).
Neurological testing (Gross Motor Function Measure, Pediatric Evaluation of Disability
Inventory, and the Test of Variables of Attention) will be performed at baseline, immediately
after experimental treatment #40, and at 3 and 6 months after experimental treatment #40.
Statistical analysis will be performed on these test data to determine any changes from
baseline, or between group differences, in the functional capabilities of the study subjects.
Condition:
Cerebral Palsy
Treatment:
Hyperbaric Oxygen Treatment
Start Date:
August 2005
Sponsor:
Dayton Children’s Hospital
For More Information:
https://clinicaltrials.gov/show/NCT00290186