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Sponsors and Collaborators: |
Wright State University Department of Defense Children's Medical Center of Dayton Kettering Medical Center |
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Information provided by: | Wright State University |
ClinicalTrials.gov Identifier: | NCT00290186 |
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 yrs with spastic 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 |
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Cerebral Palsy Cerebral Palsy, Spastic |
Procedure: Hyperbaric Oxygen Treatment (HBOT) Procedure: Hyperbaric Air Treatment (HBAT) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study |
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: | June 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 3 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Connie A Bruns, RN, BSN | 937-641-4279 | BrunsC@childrensdayton.org |
United States, Ohio | |
Children's Medical Center of Dayton | Recruiting |
Dayton, Ohio, United States, 45404-1815 | |
Contact: Connie A Bruns, RN, BSN 937-641-4279 BrunsC@childrensdayton.org | |
Wound Healing and Hyperbaric Medicine Center | Recruiting |
WPAFB, Ohio, United States, 45433-5546 | |
Contact: Bruce K Warren, RRT, RCP, CHT 937-257-8603 bruce.warren@khnetwork.org |
Principal Investigator: | Daniel J Lacey, MD, PhD | Children's Medical Center of Dayton, Neurologist |
Responsible Party: | Children's Medical Center of Dayton ( Daniel J Lacey, MD, PhD ) |
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: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00290186 |
Health Authority: | United States: Food and Drug Administration |
Cerebral Palsy Spastic Cerebral Palsy CP Hyperbaric HBOT |
Paralysis Signs and Symptoms Cerebral Palsy Brain Damage, Chronic |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases Brain Injuries |
Nervous System Diseases |