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An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy

NCT00290186 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2014-08-28

Study results available
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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.

Conditions

  • Cerebral Palsy
  • Cerebral Palsy, Spastic

Interventions

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Kettering Health Network

    collaborator OTHER

  • Dayton Children's Hospital

    lead OTHER

Principal Investigators

  • Daniel J Lacey, MD, PhD · Children's Medical Center of Dayton, Neurologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290186 on ClinicalTrials.gov