NCT00290186

An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy

An Evaluation of the Therapeutic Effectiveness of Hyperbaric Oxygen Treatments and Hyperbaric Air Treatments for Children With Cerebral Palsy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Dayton Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

The study is to evaluate the effectiveness of hyperbaric treatments and the potential longer-term effects in children between the ages of 3 and 8 years with spastic cerebral palsy (CP). One group will receive 100% oxygen and the other group will receive the equivalent of 21% oxygen (room air). The children will receive pre-treatment testing (baseline). After 40 experimental treatments are completed, the children will be retested at 0, 3, and 6 months to evaluate any changes.

Detailed 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.

Conditions

• Cerebral Palsy
• Cerebral Palsy, Spastic

Interventions

Type	Name	Description
DEVICE	Hyperbaric Oxygen Treatment	100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
DEVICE	Hyperbaric Air Treatment	14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total

Timeline

• Start date: 2005-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2006-02-10
• Last updated: 2014-08-28
• Results posted: 2014-08-28

Locations

2 sites across 1 country: United States