Period covered: 

May 2001 to July 2004

Aim of the Study

40 small CP children given Standard Therapy (OT, PT, Speech and Special Education) supplemented by 40 sessions of HBOT, followed two months later by 45 sessions of CP Specific Acupuncture and 90 days of Unani / Ayurvedic pure established herbal Neuro-restorative nutritional supplements

Versus

a similar group of 20 small CP children given ONLY Standard Therapy

at the same venue by the same set of therapists using the same protocol and equipment.

Demography

1. 60 children with mild to moderate cerebral palsy (20 given only Standard Therapy; 40 given full Multimode Therapy as an adjunct to Standard Therapy. One Brazilian child had to go back midway due to visa problems, hence 39 children evaluated. Both groups received Standard Therapy at the same center, using the same protocol, same equipments,  same group of Therapists and for the same six month period.

Regimens:

1. Standard Therapy comprising ¹/₂ hour each sessions of Physiotherapy, Occupational Therapy, Speech Therapy and Special Education at the same center, using the same protocol, same equipments,  same group of Therapists and for the same six month period.
2. Newer Multimode Therapies
   • Hyperbaric Oxygen Therapy (40 sessions during first 2 months)
   • Acupuncture for 45 to 60 sessions (After 4 months, in order to give HBOT enough time to show its effect)
   • Unani / Ayurvedic Neuro-restorative Therapy for 3 months (during last 90 days)
   • Botulinum or Phenol Nerve Block as applicable (Used initially in 9 children, but given up subsequently because its magical relief tempted the parents and children to stop the mandatory home intensive therapy; as a result, just about all the children were back to square one in less than a year. In India, the cost of corrective surgery with much longer lasting and superior results, costs the same as a course of Botox Injection.)

Inclusion Criteria:

• Small children with diagnosed CP with preferred aged < 5 years, when degree of Leukodystrophy (permanent scar in injured brain) is less
• Child must have normal health, good lungs, no upper respiratory infection or uncontrolled epileptic fits
• Detailed discussion on all modes of MMT is done with parents, to obtain their informed voluntary consent and clear all doubts
• We deliberately chose educated parents who could give informed voluntary consent for therapy of their children
• Not more than mild to moderate mental deficiency.
• Those living in Delhi or willing to live in Delhi for six months within reasonable distance of UDAAN to facilitate daily transportation

Exclusion Criteria

• Uncontrolled infection, Epilepsy, Bronchospastic and E.N.T. disorders.
• Any Genetic Disorders
• Pervasive Developmental Disorders

RESULTS

Criteria of Improvement

• It is difficult to categorize improvement. A child who was a creeper and then becomes a supported walker, as well as a slow walker who starts running, are both cases of improvement, but from a functional and ADL point of view, the former is a greater improvement whereas for the lay public, the latter is more impressive. Hence, we evolved our own methodology for improvement, based heavily on established scales, modified according to our own circumstances, facilities available and environment.
• Physical changes were measured by the GMFM-66 scale and software.
• Special Education changes were measured by our own customized Objective Criteria scale, based on REEL, FAB, Ruth-Griffith and BASIC MR Scales, customized to measure finer changes at shorter intervals of two months. We have 46 parameters, subdivided into 6 groups. Each parameter is graded into 5 objective type measurable grades of achievement. The grades were something like:
  1. = No response / activity
  2. = Can do task after verbal prompt plus physical prompt (catching limb /body and guiding the child)
  3. = Can do the task after verbal prompt plus gesture but not touching the child
  4. = Can do the task after verbal prompt only
  5. = Does the task spontaneously
• Speech changes were measured by using 9 parameters similarly graded into 5 objective type grades of improvement.

Criteria of "Response"

• We considered a child to have responded to therapy if the child improved to the next grade of response within 2 months, unless the child was already in the topmost grade.
• The number of children below the top grade who showed improvement by 1 or more grades in a 2 month period was counted separately for each parameter and compared between the Non-HBOT Group and HBOT Group.
• Assessment was done at 0, 2, 4 and 6 months.  

TABLE I

(Table Showing Age and Sex differences between the two groups)

MOTOR FUNCTIONS

TABLE II

 (Table showing GMFM Scores obtained by the two groups)

TABLE III

 (Table showing Statistical Evaluation of GMFM Scores obtained by the two groups)

		Levene's Test for Equality of Variances		t-test for Equality of Means
		F	Sig.	t	Df	Sig. (2-tailed)	Mean Difference	Std. Error Difference	95% Confidence Interval of the Difference
									Lower	Upper
Change from 6 months to Baseline	Equal variances assumed	8.053	.006	6.032	57	0.000 Signif.	17.60	2.92	11.75	23.44
	Equal variances not assumed			7.275	56.928	0.000 Signif.	17.60	2.42	12.75	22.44

 

SPECIAL EDUCATION PARAMETERS

TABLE IV

(Table showing Change from Baseline Scores in Special Education obtained by the two groups)

TYPE		Cognitive (Mental Evaluation)	Social & Emotional	Brushing	Feeding and Drinking	Toileting	Dressing and Undressing	Total for All Six Groups
HBOT (n=39)	Mean	25.74	6.08	4.18	6.97	3.10	5.54	51.62
	Std. Deviation	18.02	3.61	4.08	5.19	2.43	3.88	30.65
	Std. Error of Mean	2.89	.58	.65	.83	.39	.62	4.91
Non-HBOT (n=20)	Mean	15.40	4.80	2.40	3.15	1.20	3.15	30.10
	Std. Deviation	13.83	3.65	3.27	4.67	1.85	2.39	25.46
	Std. Error of Mean	3.09	.82	.73	1.04	.41	.53	5.69

TABLE V

NPar Tests

Mann-Whitney Test 

(Table showing significance of improvement in Special Education values in HBOT Group over Non-HBOT group )

	Cognitive (Mental Evaluation)	Social & Emotional	Brushing	Feeding and Drinking	Toileting	Dressing and Undressing	Total for All Six Groups
Mann-Whitney U	257.000	299.500	285.000	208.500	206.500	258.000	222.000
Wilcoxon W	467.000	509.500	495.000	418.500	416.500	468.000	432.000
Z	-2.131	-1.458	-1.714	-2.929	-3.011	-2.141	-2.691
Asymp. Sig. (2-tailed)	.033 (S)	.145 (NS)	.086 (NS)	.003 (S)	.003 (S)	.032 (S)	.007 (S)

SPEECH THERAPY PARAMETERS

TABLE VI

(Showing mean values in Speech parameters from baseline to 6 Month)

GROUP		Basal	2 Month	4 Month	6 Month	Change from baseline
HBOT (n=39)	Mean	14.31	17.69	21.90	25.44	11.13
	Std. Deviation	5.98	6.14	6.96	7.52
	Std. Error of Mean	.96	.98	1.11	1.20
Non-HBOT (n=20)	Mean	15.00	16.90	20.20	23.05	8.05
	Std. Deviation	7.17	7.89	8.79	9.40
	Std. Error of Mean	1.60	1.77	1.97	2.10

TABLE VII

NPar Tests

Mann-Whitney Test

(Table showing significance of improvement in Speech Parameters in HBOT Group over Non-HBOT group )

	After 6 months
Mann-Whitney U	237.000
Wilcoxon W	447.000
Z	-2.469
Asymp. Sig. (2-tailed)	.014 (S)

FIGURE I

(Figure showing differences in Special Education parameters over six months in HBOT and NON-HBOT Groups)

Overall, the results obtained so far suggest that at 4th Month: HBOT Group scores are better than the  NON-HBOT Group scores, but the results are NOT STATISTICALLY SIGNIFICANT.

By the 6th Month: the improvement in the HBOT Group is statistically significantly superior to the NON-HBOT groups in :

• Physical parameters (p<0.001) 
• Special Education four out of six Groups (p < 0.05 to 0.005)
• Special Education total scores (p=0.007)
• Speech total parameters (p=0.014). 

The results suggest that both MMT given as an adjunct to OT/PT and OT/PT without MT are effective in improving the Gross Motor Abilities, Special Education parameters and Speech parameters of CP children. 
However, the rate of improvement in the Experimental Group is nearly twice than the Control Group after six months, as evident from the Tables and Graph. The changes reach statistical significance between the two groups only after six months.

The results indicate that HBOT based Multimode therapy may offer a better quality of life to small children with CP as compared to Standard Therapy alone. Many of these children achieved ADL within ½ to 1 year.

Adverse effects

• Diarrhea to the Unani Herbal Drug: 2 cases
• Mild rash: 1 case
  Subsided with symptomatic therapy
  None of them required discontinuation of drug.
• Acupuncture produced mild pain initially
  Subsided on continued therapy (?? Analgesic effect??) 
• Relapse of Epilepsy: 1 case (?? Reperfusion injury)
  Occurred during the 3rd week of HBOT 
  Treated by increasing dose of the anti-epileptics
  Could resume HBOT after a month.
• No other Adverse Effect on Lung, ENT or any other system with HBOT-based MMT

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