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| ID | Type | Description | Link |
|---|---|---|---|
| FWP20020014H | |||
| DAMD17-03-2-0060 | |||
| HSRRB-12213 | |||
| CMC 04-024 | |||
| KMCN 03-021 |
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Terminated for futility.
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Kettering Health Network | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen Treatment (HBO) | Experimental | 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total |
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| Hyperbaric Air Treatment (HBA) | Active Comparator | 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Treatment | Device | 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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] | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | GMFM-66: total percent score on 66-item subscale of GMFM-88: Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score determined by dividing score obtained by maximum possible score for the 66 items, and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. GMFM-66: [(total score on subset of 66 items/198)x100]. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Lacey, MD, PhD | Children's Medical Center of Dayton, Neurologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dayton Children's Hospital | Dayton | Ohio | 45404-1815 | United States | ||
| Wound Healing and Hyperbaric Medicine Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23071074 | Result | Lacey DJ, Stolfi A, Pilati LE. Effects of hyperbaric oxygen on motor function in children with cerebral palsy. Ann Neurol. 2012 Nov;72(5):695-703. doi: 10.1002/ana.23681. Epub 2012 Oct 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyperbaric Oxygen Treatment (HBO) | Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total 25 Were allocated to HBO 24 Completed all 40 treatments 1 Withdrawn during treatments due to right ear problems and rectal bleeding 24 Completed post treatment testing
1 Missed 3-month followup due to illness not related to study but returned for 6-month followup testing 20 Completed 3-month followup testing 20 Completed 6-month testing 24 Included in pre and post treatment analyses 20 Included in pre, post, and 3-month analyses 20 Included in pre, post, 3-month and 6-month analyses |
| FG001 | Hyperbaric Air Treatment (HBA) | Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total 24 Were allocated to HBA 22 Completed all 40 treatments 1 Withdrew prior to treatments 1 Withdrawn during treatments for seizures due to shunt malfunction 22 Completed post treatment testing 1 Study terminated prior to 3-month followup testing 21 Completed 3-month followup testing 1 Did not return for 6-month followup testing 1 Missed 6-month followup testing due to illness not related to study 19 Completed 6-month followup testing 22 Included in pre and post treatment analyses 21 Included in pre, post, and 3-month analyses 19 Included in pre, post, 3-month and 6-month analyses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperbaric Oxygen Treatment (HBO) | Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total |
| BG001 | Hyperbaric Air Treatment (HBA) | Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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] | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyperbaric Oxygen Treatment (HBO) | Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal bleeding | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ear pain | Ear and labyrinth disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel J. Lacey, MD, PhD | Dayton Children's Hospital | 937-641-3080 | LaceyD@childrensdayton.org |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Hyperbaric Air Treatment | Device | 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total |
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| 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 | Total percent score on 17 items of GMFM grouped into Dimension A) lying and rolling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension A determined by dividing score obtained by maximum possible score for that dimension (51), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. A) lying and rolling: (score achieved/51)x100. | 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 | Total percent score on 20 items of GMFM grouped into Dimension B) sitting. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension B determined by dividing score obtained by maximum possible score for that dimension (60), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. B) sitting: (score achieved/60)x100. | 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 | Total percent score on 14 items of GMFM grouped into Dimension C) crawling and kneeling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension C determined by dividing score obtained by maximum possible score for that dimension (42), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. C) crawling and kneeling: (score achieved/42)x100. | 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 | Total percent score on 13 items of GMFM grouped into Dimension D) standing. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension D determined by dividing score obtained by maximum possible score for that dimension (39), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. D) standing: (score achieved/51)x100. | 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 | Total percent score on 24 items of GMFM grouped into Dimension E) walking, running, and jumping. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension E determined by dividing score obtained by maximum possible score for that dimension (72), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. E) walking, running, and jumping: (score achieved/72)x 100. | 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 | Primary caregiver-reported (through structured interview) child capabilities for 73 items of functional skills grouped under self-care. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-73 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities. | 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 | Primary caregiver-reported (through structured interview) child capabilities for 59 items of functional skills grouped under mobility. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-59 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities. | 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 | Primary caregiver-reported (through structured interview) child capabilities for 65 items of functional skills grouped under social function. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-65 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities. | 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 | Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 8 items of daily activity grouped under self-care. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-40 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently. | 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 | Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 7 items of daily activity grouped under mobilityare. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-35 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently. | 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 | Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 5 items of daily activity grouped under social function. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-25 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently. | 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. | One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly selected when it appears on a screen. Score ranges from 0-160; higher scores represent greater 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. | One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly not selected (number of times a child correctly refrains from hitting a buzzer) when it appears on a screen. Score ranges from 0-160; higher scores represent greater 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 | One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the processing time in milliseconds that it takes to correctly respond to a target. Lower times represent better response times. Range = 0 - 2000 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 | One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the variability in processing time in milliseconds that it takes to correctly respond to a target. Response time variability = the standard deviation of response times for correct responses. Lower values represent less variability and better responses. Range of response times = 0-2000 milliseconds. | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
| Wpafb |
| Ohio |
| 45433-5546 |
| United States |
| Study was terminated prior to 3-month te |
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| Withdrawal by Subject |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Gross Motor Function Classification System (GMFCS) level | GMFCS© Robert Palisano, Peter Rosenbaum, Stephen Walter, Dianne Russell, Ellen Wood, Barbara Galuppi, 1997. CanChild Centre for Childhood Disability Research, McMaster University. (Reference: Dev Med Child Neurol 1997;39:214-223). Levels I-V based on self-initiated movement, with emphasis on sitting, transfers, and mobility. Level I is highest functioning, level V is lowest General: I: walks without limitations II: walks with limitations III: walks using hand-held mobility device IV: self-mobility with limitations; may use powered mobility V: transported in manual wheelchair | Number | participants |
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| Secondary | 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). | GMFM-66: total percent score on 66-item subscale of GMFM-88: Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score determined by dividing score obtained by maximum possible score for the 66 items, and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. GMFM-66: [(total score on subset of 66 items/198)x100]. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension A | Total percent score on 17 items of GMFM grouped into Dimension A) lying and rolling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension A determined by dividing score obtained by maximum possible score for that dimension (51), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. A) lying and rolling: (score achieved/51)x100. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension B | Total percent score on 20 items of GMFM grouped into Dimension B) sitting. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension B determined by dividing score obtained by maximum possible score for that dimension (60), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. B) sitting: (score achieved/60)x100. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension C | Total percent score on 14 items of GMFM grouped into Dimension C) crawling and kneeling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension C determined by dividing score obtained by maximum possible score for that dimension (42), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. C) crawling and kneeling: (score achieved/42)x100. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension D | Total percent score on 13 items of GMFM grouped into Dimension D) standing. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension D determined by dividing score obtained by maximum possible score for that dimension (39), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. D) standing: (score achieved/51)x100. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension E | Total percent score on 24 items of GMFM grouped into Dimension E) walking, running, and jumping. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension E determined by dividing score obtained by maximum possible score for that dimension (72), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. E) walking, running, and jumping: (score achieved/72)x 100. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | 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 | Primary caregiver-reported (through structured interview) child capabilities for 73 items of functional skills grouped under self-care. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-73 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | 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 | Primary caregiver-reported (through structured interview) child capabilities for 59 items of functional skills grouped under mobility. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-59 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | 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 | Primary caregiver-reported (through structured interview) child capabilities for 65 items of functional skills grouped under social function. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-65 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | 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 | Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 8 items of daily activity grouped under self-care. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-40 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | 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 | Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 7 items of daily activity grouped under mobilityare. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-35 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | 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 | Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 5 items of daily activity grouped under social function. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-25 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently. | Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period) |
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| Secondary | 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. | One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly selected when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct responses. | The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | 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) |
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| Secondary | 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. | One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly not selected (number of times a child correctly refrains from hitting a buzzer) when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct nonresponses. | The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | 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) |
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| Secondary | 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 | One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the processing time in milliseconds that it takes to correctly respond to a target. Lower times represent better response times. Range = 0 - 2000 milliseconds | The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | 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) |
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| Secondary | 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 | One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the variability in processing time in milliseconds that it takes to correctly respond to a target. Response time variability = the standard deviation of response times for correct responses. Lower values represent less variability and better responses. Range of response times = 0-2000 milliseconds. | The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment). | Posted | Mean | 95% Confidence Interval | 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) |
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| 1 |
| 25 |
| 7 |
| 25 |
| EG001 | Hyperbaric Air Treatment (HBA) | Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total | 1 | 24 | 8 | 24 |
| fluid in ear and nose | Ear and labyrinth disorders |
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| seizure | Nervous system disorders |
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