Cerebral PalsyNCT00290186

An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy

A study testing Hyperbaric Oxygen Treatment and Hyperbaric Air Treatment in people with Cerebral Palsy and Cerebral Palsy, Spastic, run by Dayton Children's Hospital at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 3 to 8 years
Conditions the study is for: Cerebral Palsy, Cerebral Palsy, Spastic
What is being tested?: Hyperbaric Oxygen Treatment and Hyperbaric Air Treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 2 sitesUnited States
Study dates: Aug 2005to Nov 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Dayton Children's Hospital
Dayton, Ohio, 45404-1815
Wound Healing and Hyperbaric Medicine Center
Wpafb, Ohio, 45433-5546

Other trials in United States

About this study

Official title: An Evaluation of the Therapeutic Effectiveness of Hyperbaric Oxygen Treatments and Hyperbaric Air Treatments for Children With Cerebral Palsy

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.

Read the detailed description

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.

Conditions: Cerebral Palsy, Cerebral Palsy, Spastic
Being tested: Hyperbaric Oxygen Treatment, Hyperbaric Air Treatment
Keywords: Cerebral Palsy, Spastic Cerebral Palsy, CP, Hyperbaric, HBOT
Medical subject headings: Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyperbaric Oxygen TreatmentDevice
Also called HBOT, HBO
100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
Hyperbaric Air TreatmentDevice
Also called HBAT, HBA
14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total

Study groups in NCT00290186
Study group	Role	What they receive
Hyperbaric Oxygen Treatment (HBO)	Experimental	100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total Receives: Device: Hyperbaric Oxygen Treatment
Hyperbaric Air Treatment (HBA)	Active comparator	14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total Receives: Device: Hyperbaric Air Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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:
1. 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]
Measured: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)

Secondary outcomes (16)

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].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2005Nov 2012

First posted10 Feb 2006 (estimated)
Study startAug 2005
Primary completionNov 2012
Study completionNov 2012

Why it stopped: Terminated for futility.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cerebral PalsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00290186
Sponsor's protocol ID: 03038007
Other IDs: FWP20020014H, DAMD17-03-2-0060, HSRRB-12213, CMC 04-024, KMCN 03-021
Status last verified: Aug 2014
First submitted: 8 Feb 2006
Last updated: 28 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23071074

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Therapeutic Effectiveness of Hyperbaric Oxygen Treatments and Hyperbaric Air Treatments for Children With Cerebral Palsy
ClinicalTrials.gov ID: NCT00290186
Acronym / sponsor ID: 03038007
Conditions: Cerebral Palsy, Cerebral Palsy, Spastic
Keywords: Cerebral Palsy, Spastic Cerebral Palsy, CP, Hyperbaric, HBOT
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated for futility.
Enrolment: 49 participants (actual)
Lead sponsor: Dayton Children's HospitalUniversity, hospital or other
Collaborators: United States Department of Defense, Kettering Health Network
Study start: Aug 2005
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 10 Feb 2006 (estimated)
Results: Posted 28 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Hyperbaric Oxygen Treatment (HBO)	Experimental	Device: Hyperbaric Oxygen Treatment100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
Hyperbaric Air Treatment (HBA)	Active comparator	Device: Hyperbaric Air Treatment14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total

Who may qualify

Ages: 3 to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hyperbaric Oxygen TreatmentAlso: HBOT, HBO100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total	Device	Hyperbaric Oxygen Treatment (HBO)
Hyperbaric Air TreatmentAlso: HBAT, HBA14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total	Device	Hyperbaric Air Treatment (HBA)

Primary outcome

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).
Time frame: 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]

16 secondary outcomes

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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)

Results and safety

Results posted to the registry on 28 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hyperbaric Oxygen Treatment (HBO)	25	20
Hyperbaric Air Treatment (HBA)	24	19

Primary outcome: 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).

Time frame: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period). Mean (95% Confidence Interval). Unit: units on a scale

Measure	Hyperbaric Oxygen Treatment (HBO) n = 24	Hyperbaric Air Treatment (HBA) n = 22
Value	1.5 (-0.3 to 3.3)	0.6 (-1.0 to 2.2)

Hyperbaric Oxygen Treatment (HBO) vs Hyperbaric Air Treatment (HBA): Mean Difference (Final Values): 0.9 (95% CI -1.5 to 3.3), p = 0.539, ANCOVA

Population analysed: 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).

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hyperbaric Oxygen Treatment (HBO)	1 of 25 (4%)	7 of 25 (28%)	Not reported
Hyperbaric Air Treatment (HBA)	1 of 24 (4.2%)	8 of 24 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23071074Lacey 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel J Lacey, MD, PhD principal investigator

Children's Medical Center of Dayton, Neurologist

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hyperbaric Oxygen Treatment and Hyperbaric Air Treatment in people with Cerebral Palsy and Cerebral Palsy, Spastic, run by Dayton Children's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00290186, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2014.