An Evaluation of the Therapeutic Effectiveness of Hyperbaric Oxygen Treatments and Hyperbaric Air Treatments for Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Total Score (GMFM-88).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children, ages 3 to 8 years with a diagnosis of spastic cerebral palsy.
- •No documented evidence of hypoxic-ischemic encephalopathy (HIE). Hypoxic-ischemic encephalopathy (HIE) is not one of the major causes of CP.
- •Medically cleared to participate. Your child's primary care physician will be asked to medically clear your child before entering the study.
- •Able to pass pretest screening exercise. Each child will undergo the following screening exercise to determine the likelihood of being able to participate in the study: In order to assess ability to tolerate the placement of the oxygen hood in the hyperbaric setting, a hyperbaric oxygen hood will be placed upon the shoulders, or body of your child (depending upon size of your child) and with encouragement and comforting by you and study nurse, the child will be asked to maintain the placement of the hood for 15 minutes. Each child will be asked to blow through a straw, blow the nose, drink through a straw, or to swallow on command.
排除标准
- •Any previous HBO treatments.
- •Thoracic surgery within 6 months of beginning the study.
- •Unstable epilepsy as determined by a history of having had more than one major motor (generalized or partial tonic/clonic) seizure within the past six months. Having multiple motor seizures, requiring more than three anticonvulsant drugs for seizure control; or requiring changes in seizure medications more than once per month.
- •Significant pulmonary dysfunction as determined by a history of chronic pulmonary disease, cystic fibrosis, interstitial lung disease, or chronic shortness of breath or cough. Uncontrolled asthma/reactive airway disease.
- •Significant behavioral problems requiring medication.
- •Any major congenital deformities of the brain or spinal cord.
- •Active pneumothorax (collapsed lung).
- •Recent cancer treatment with cisplatinum, bleomycin, or doxorubicin.
- •Certain heart problems that cause the heart to pump poorly as determined by a history of congenital heart disease, cardiomyopathy, or symptoms of chest pain, dizziness, and shortness of breath.
- •Optic neuritis.
- •Diabetics requiring insulin therapy.
- •Spherocytosis.
- •Major GI reflux with frequent emesis.
- •Botulinum toxin A (Botox) treatments within 6 months of entering study.
- •Before entering the study, we will require that chronic medications be unchanged for the prior three months except for minor dosage adjustments.
结局指标
主要结局
The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Total Score (GMFM-88).
时间窗: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)
GMFM-88: total percent score on 88 items (I) of motor function grouped into 5 dimensions: A) lying and rolling (17 I), B) sitting (20 I), C) crawling and kneeling (14 I), D) standing (13 I), E) walking, running, jumping (24 I). Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Scores in each dimension determined by dividing score obtained by maximum possible score for that dimension, and multiplying by 100. Range is 0-100% for each: the higher the percent score, the greater the functional ability. Dimension scores and total GMFM-88 score calculated as: A) lying and rolling: (score achieved/51)x100 B) sitting: (score achieved/60)x100 C) crawling and kneeling: (score achieved/42)x100 D) standing: (score achieved/39)x100 E) walking, running, and jumping: (score achieved/72)x 100 GMFM-88 = (%A+%B+%C+%D+%E)/number of dimensions GMFM-66: \[(total score on subset of 66 items/198)x100\]
次要结局
- The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure 66-Item Subscale Score (GMFM-66).(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension A(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension B(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension C(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension D(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension E(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Self-care(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Mobility(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Social Function(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Self-care(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Mobility(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Social Function(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Responses.(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Nonresponses.(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time in Milliseconds(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))
- The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time Variability in Milliseconds(Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period))