Hyperbaric Therapy-Based Multimode Therapy for children
with Cerebral Palsy
Dr. Arun Mukherjee, MD
Director, UDAAN for the Differently Abled,
A-59 Kailash Colony, New Delhi, India
INTRODUCTION
Cerebral Palsy (CP):
Abnormalities of tone are an integral component of many chronic motor disorders of childhood. These disorders result from dysgenesis or injury to developing motor pathways in
the cortex, basal ganglia, thalamus, cerebellum, brainstem, central white matter or spinal cord. The major damage is to the developing fetal / neonatal brain, mostly affecting the
poorly vascularized Internal Capsule, Descending Cerebro- and Cerebello- Spinal tracts, thus affecting various motor functions. When the injury occurs in children before 2 years of age, the term Cerebral Palsy (CP) is often used.
Management of CP
The classical management of CP is Standard Therapy comprising individualised, need based
and target-oriented Physiotherapy, Occupational therapy, Special Education and Speech
Therapy. These are often offered as exotic management techniques such as Peto technique,
NDT (Neuro-Developmental Therapy), Bobbath technique, etc. Down at heart, they are all
specialised forms of Standard Therapy to derive the best physical and psychosocial outcomes
within the possibilities of neural function left after the original brain injury. Hoping that these standard therapies alone can solve the problems of the CP child is like hoping that changing the tyres and lubricating the wheels and axles of a car will make it run better when its engine is choked with carbon deposits. We need to repair the engine if the fault is in the engine: it is as simple as that.
There are dozens of papers in world literature, unfortunately not indexed in “Free Internet
Medline” but in other more than 100 “*Lines” in the US National Library of Congress, that
are available only on payment per article, and hence rarely sought out. They carry many
reports on CP children treated with Hyperbaric Oxygen Therapy, showing improvement and
increase in serial GMFM scores over time that were five to ten times faster than that achieved
in the best centres of standard therapies.
UDAAN for the Disabled
UDAAN for the Disabled is a non-profit organization, recognized and partially aided by the
Government of India. We are offering standard therapies since 1994 to children affected by
various forms of Neurodevelopmental disabilities, in which CP predominates. Since 2001, we
started a research project to study the benefits of HBOT-based multimode therapy of CP. We
have a control batch of CP children that did not receive HBOT, as well as batches that
received HBOT in a Multiplace rigid chamber either at 1.75 ATA (till July 2004) or 1.5 ATA
(after July 2004) with 100% oxygen delivered by an Amron mask. There is a fourth batch
that received mild pressurized air (with no additional oxygen supplementation either with a
Concentrator or oxygen cylinder) at 1.3 ATA using the largest size OxyHealth soft portable
chamber (since 2006).
The study is a prospective open non-randomised study, with batches decided by the parent
based on their own convenience and financial status. It is an ongoing study. Hence, our
database is growing by the year. This article represents data as available till June 2008.
Evolution of existing HBOT based Multimode Therapy for CP in India
June 2001 UDAAN pioneered in India the study of 1.75 HBOT at 100% O2 as supplement to Standard Therapy (OT + PT + Special Education + Speech Therapy) for CP children.
March 2003
The first UDAAN paper on the use of HBOT in CP (Control 15 vs Test 15) was presented at
the Annual Conference of Indian occupational Therapy Assoc. at Bangalore (Amit Sethi and
Arun Mukherjee) and won the best scientific paper award. This was later reported in
July 2003
3rd Int. Symposium on HBOT & the Brain Damaged Child (Florida): Presented interim data
on 20 CP children given only Standard Therapy vs. 20 matching Test group of 20 CP
Children given additional HBOT (40 sessions of 1.75 ATA with 100% O2). Trend favored
the HBOT group on all parameters.
July 2004
4th Int. Symp. on HBOT …. (Florida): Presented data on 39 CP children given 40 sessions of
HBOT at 1.75 ATA, with statistically significant improvement over the batch given only
Standard Therapy (n=20) .
Dr. Paul Harch advised us to shift down to 1.5 ATA for better results. We did as advised.
July 2006
5th Int. Symp. on HBOT …. (Florida): Presented ongoing long term (6 to 8 months) study
data of 84 CP children given supplemental HBOT (sub-group analysis of 1.5 & 1.75 ATA not
done) Vs. 20 on Standard Therapy alone.
Data on interim pilot study on 7 given 1.3 ATA Hyperbaric Air also shown but not included
in analysis.
July 2008
6th Int. Symp. on HBOT …. (Torrance CA): Presented data on 128 CP children who
completed at least six months of follow up, after receiving only Standard Therapies (n=20),
or standard therapies supplemented by (a) regular 100% O2 HBOT at 1.75 ATA (n=60), (b)
regular 100% O2 HBOT at 1.5 ATA (n=24), or (c) HB-Air at 1.3 ATA using room air only
(n=24).
Materials and Methods
Selection Criteria
Inclusion Criteria
• All types of CP in children aged mostly between 1 to 5 years, oldest up to Teen age
• Either Sex
• Any I.Q. level
• Pre-HBOT SPECT Scan showing presence of recoverable penumbra in test subjects.
• Those living in Delhi or willing to live in Delhi for 6 - 8 months within reasonable
distance of UDAAN to facilitate daily transportation
Exclusion Criteria
• Uncontrolled Epilepsy
• Uncontrolled Bronchospastic and/or E.N.T. disorders.
• Any Genetic Disorders
• Pervasive Developmental Disorders.
Grouping
Every child received matching Standard Therapy at the same venue by the same group of
therapists, using the same protocol, same equipment, and the same duration of 6 to 8 months.
• Batch – A: No hyperbaric therapy
• Batch – B: 40 sessions of 1.75 ATA HBOT with 100% Oxygen during 1st two months
• Batch – C: 40 sessions of 1.50 ATA HBOT with 100% Oxygen during 1st two months
• Batch – D: 40 sessions of 1.30 ATA HBAT with room air during 1st two months
1. The Hyperbaric groups also received CP Specific Acupuncture one session a day for 60
sessions as part of multimode therapy, added from 5th month onwards, after giving
HBOT / HBA enough time to exert its effects.
2. Assessments done every 2 months
3. Data analyzed for Percentage Change from Basal to 4 and 6 Months.
Physical Assessment
• Standard Scales like GMFM scale are always used. We also use other relevant scales
where needed, like Modified Ashworth, BERI VMI, etc. The analytical data is based
on the GMFM Scale.
• GMFM Measurements: Baseline, 4 months & 6 months, and now-a-days, 8 months
• Statistical evaluation: By a Bio-statistician trained at the prestigious All India Institute
of Medical Sciences, Delhi
Statistical Methods used by our Statistician
• Chi Squared Test for Categorical Data
• Non Parametric Wilcoxon Mann Whitney Test for 2 Groups
• Non Parametric Krusckal Wallis Test for more than 2 Groups
• Non Parametric Wilcoxon Signed Rank Test for two different time periods
Assessments other than Physical
Special Educational and Speech Therapist’s assessments are always a problem in CP due to
combination of intellectual disability & physical impairment in the children.
Hence, based on our long experience with various scales, we developed a modified scale of
22 objective parameters for cognitive changes (Special Education)
Evolved from standard scales like Vineland, Help Check list; RUTTH GRIFFITH; REEL;
FAB & BASIC MR. Each parameter has been divided into 5 achievable grades of
improvement. These grading have been customized to measure smaller differences in
Cognitive skills at 2 month intervals.
UDAAN Study Timeline
Protocol - Standard Therapy
6 days/week, one-to-one basis, ½ Hr each daily of
1. Physiotherapy
2. Occupational Therapy
3. Special Education
4. Speech Therapy
Assessment of fitness for Hyperbaric Therapy
Pre-HBOT SPECT Scan was done in just about every child to show ischemic brain lesion.
Each child had to undergo medical fitness by a pediatrician and an ENT specialist to ensure
safety at hyperbaric conditions. Neurological opinion was sought in children with fits, and
where needed, dose of anti-epileptic therapy was slightly increased during the HBOT phase
to minimize risk of fit relapse.
Protocol Hyperbaric Oxygen Therapy Regimen
HBOT was done in a multiplace chamber using 15 minutes to pressurize, 15 minutes to
depressurize, and 60 minutes at pressure with 100% Oxygen given through an Amron mask.
The children received one session of HBOT a day x 40 sessions during 1st two months. The
pressure used was 1.75 ATA from 2001 to July 2004, which was subsequently reduced to 1.5
ATA as per guidance received from our mentor, Dr. Paul Harch.
Hyperbaric Air Therapy Regimen
HBAT was done in a non-ASME-PVHO compliant OxyHealth soft chamber (their largest
chamber size used) as part of our research protocol, at 1.3 ATA using non-enriched room air,
in a dedicated air-conditioned room with filtered air. This batch duplicates the batch wrongly
and repeatedly referred to as “Placebo” by Collet, the lead author of the landmark Canadian
study of HBOT in CP (Collet, J.P., Vanasse, M., Marois, P., Amar, M., Goldberg, J., Lambert, J. et
al. (2001) Hyperbaric oxygen for children with cerebral palsy: A randomized multicentre trial. The
Lancet, 357, 582-586). Each child received one session a day x 40 days during first 2 months.