Trial Outcomes & Findings for An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy (NCT NCT00290186)
NCT ID: NCT00290186
Last Updated: 2014-08-28
Results Overview
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: \[(total score on subset of 66 items/198)x100\]
TERMINATED
NA
49 participants
Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)
2014-08-28
Participant Flow
Participant milestones
| Measure |
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1 Withdrawn during treatments due to right ear problems and rectal bleeding 24 Completed post treatment testing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. Study terminated prior to 3-month followup testing
2. Did not return for 3- or 6-month followup 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
|
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1 Withdrawn during treatments for seizures due to shunt malfunction 22 Completed post treatment testing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
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
Completed Baseline Assessments
|
25
|
24
|
|
Overall Study
Completed 8 Weeks of Treatment
|
24
|
22
|
|
Overall Study
Completed Post-treatment Assessments
|
24
|
22
|
|
Overall Study
Completed 3-month Followup Assessments
|
20
|
21
|
|
Overall Study
Completed 6-month Followup Assessments
|
20
|
19
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
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. Study terminated prior to 3-month followup testing
2. Did not return for 3- or 6-month followup 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
|
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Study was terminated prior to 3-month te
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy
Baseline characteristics by cohort
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=25 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=24 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
6.3 years
STANDARD_DEVIATION 1.3 • n=99 Participants
|
5.2 years
STANDARD_DEVIATION 2.0 • n=107 Participants
|
5.8 years
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
24 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Gross Motor Function Classification System (GMFCS) level
I
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Gross Motor Function Classification System (GMFCS) level
II
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Gross Motor Function Classification System (GMFCS) level
III
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Gross Motor Function Classification System (GMFCS) level
IV
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Gross Motor Function Classification System (GMFCS) level
V
|
13 participants
n=99 Participants
|
9 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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: \[(total score on subset of 66 items/198)x100\]
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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).
|
1.5 units on a scale
Interval -0.3 to 3.3
|
0.6 units on a scale
Interval -1.0 to 2.2
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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: \[(total score on subset of 66 items/198)x100\].
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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).
|
1.2 units on a scale
Interval -0.1 to 2.2
|
1.1 units on a scale
Interval -0.1 to 2.4
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension A
|
1.1 units on a scale
Interval -1.3 to 3.6
|
0.1 units on a scale
Interval -3.3 to 3.5
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension B
|
-0.1 units on a scale
Interval -2.3 to 2.1
|
1.4 units on a scale
Interval -1.7 to 4.4
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension C
|
3.0 units on a scale
Interval -1.0 to 6.9
|
-0.5 units on a scale
Interval -4.0 to 2.9
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension D
|
1.7 units on a scale
Interval -1.7 to 5.1
|
0.7 units on a scale
Interval -1.5 to 2.9
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension E
|
1.6 units on a scale
Interval -0.6 to 3.8
|
1.3 units on a scale
Interval -0.3 to 2.8
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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
|
4.4 units on a scale
Interval 2.3 to 6.5
|
3.3 units on a scale
Interval 1.6 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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
|
2.8 units on a scale
Interval 1.2 to 4.4
|
2.7 units on a scale
Interval 0.7 to 4.6
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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
|
2.1 units on a scale
Interval 0.4 to 3.8
|
1.9 units on a scale
Interval 0.4 to 3.4
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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
|
4.9 units on a scale
Interval 2.8 to 6.9
|
2.6 units on a scale
Interval 1.3 to 3.9
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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
|
2.7 units on a scale
Interval -0.1 to 5.6
|
3.4 units on a scale
Interval 1.5 to 5.2
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=24 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=22 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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
|
0.7 units on a scale
Interval -1.7 to 3.1
|
2.4 units on a scale
Interval 0.4 to 4.4
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=7 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=3 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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.
|
12 number of correct responses
Interval -22.0 to 46.0
|
-34 number of correct responses
Interval -175.0 to 108.0
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=7 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=3 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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.
|
3 Number of correct nonresponses
Interval -6.0 to 12.0
|
4 Number of correct nonresponses
Interval -6.0 to 14.0
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=7 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=3 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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
|
-45 time in milliseconds
Interval -113.0 to 23.0
|
33 time in milliseconds
Interval -164.0 to 231.0
|
SECONDARY outcome
Timeframe: Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)Population: 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).
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.
Outcome measures
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=7 Participants
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=3 Participants
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
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
|
-47 time in milliseconds
Interval -110.0 to 15.0
|
-9 time in milliseconds
Interval -220.0 to 201.0
|
Adverse Events
Hyperbaric Oxygen Treatment (HBO)
Hyperbaric Air Treatment (HBA)
Serious adverse events
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=25 participants at risk
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=24 participants at risk
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
Gastrointestinal disorders
Rectal bleeding
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
|
Ear and labyrinth disorders
fluid in ear and nose
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
seizure
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Hyperbaric Oxygen Treatment (HBO)
n=25 participants at risk
Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
Hyperbaric Air Treatment (HBA)
n=24 participants at risk
Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
|
|---|---|---|
|
Ear and labyrinth disorders
ear pain
|
28.0%
7/25 • Number of events 7
|
33.3%
8/24 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place