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| Sponsor: | Wright State University |
|---|---|
| Collaborators: |
Department of Defense Children's Medical Center of Dayton Kettering Medical Center |
| Information provided by: | Wright State University |
| ClinicalTrials.gov Identifier: | NCT00290186 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebral Palsy Cerebral Palsy, Spastic |
Procedure: Hyperbaric Oxygen Treatment Procedure: Hyperbaric Air Treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | An Evaluation of the Therapeutic Effectiveness of Hyperbaric Oxygen Treatments and Hyperbaric Air Treatments for Children With Cerebral Palsy |
| Estimated Enrollment: | 94 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: HBO |
Procedure: Hyperbaric Oxygen Treatment
100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
Other Names:
|
| Active Comparator: HBA |
Procedure: Hyperbaric Air Treatment
14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Children's Medical Center of Dayton | |
| Dayton, Ohio, United States, 45404-1815 | |
| Wound Healing and Hyperbaric Medicine Center | |
| Wpafb, Ohio, United States, 45433-5546 | |
| Principal Investigator: | Daniel J Lacey, MD PhD | Children's Medical Center of Dayton, Neurologist |
More Information
| Responsible Party: | Daniel J Lacey, MD PhD, Children's Medical Center of Dayton |
| ClinicalTrials.gov Identifier: | NCT00290186 History of Changes |
| Other Study ID Numbers: | 03038007, FWP20020014H, DAMD17-03-2-0060, HSRRB-12213, CMC 04-024, KMCN 03-021 |
| Study First Received: | February 8, 2006 |
| Last Updated: | December 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Cerebral Palsy Spastic Cerebral Palsy CP Hyperbaric HBOT |
|
Cerebral Palsy Paralysis Brain Damage, Chronic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |