A trial to study the add on effects of Ayurveda in the treatment of cerebral palsy

Phase 2/3

Recruiting

Brief Summary: Cerebralpalsy (CP) is the most common motor disability in childhood. Among the motor disorders, spasticity is a majorchallenge for rehabilitation of children with cerebral palsy. Spasticity canprevent or hamper function, cause pain, disturb sleep, cause unnecessarycomplications and present major difficulties for care workers. Thereis an increasing trend in the use of complementary and alternative medicineworldwide. Combination of Complementary or alternative medicine with theconventional therapy may help to improve the quality of life in patients withCP. As per the report of a survey Ayurveda as a part of Complimentary and AlternativeMedicine was used by 7% of the families for their child. Several studies havebeen reported in the management of CP using Ayurveda therapies. But thesestudies showed a wide range of differences in the selection of treatmentmodalities, duration of treatment, outcome measures etc. So current treatmentprotocol attempts to explore Multiple Ayurveda treatment modalities includingUdwartana (application of medicated powder with gentle rub), Abyangam(application of medicated oil), Shiropichu (application of cotton swab soakedin oil over the site of bregma) and kayaseka (pouring warm medicated oil in aspecific manner) with oral administration of Ashwagandha churnam in childrenwith Spastic cerebral Palsy.

Recruitment & Eligibility

Inclusion Criteria

Children diagnosed with Spastic CP 2.
Age between 2 and 12 years 3.
Both Genders 3.
Gross Motor Function Classification System levels II, III, IV&V (Detailed in Annexure- II) 4.
Patients/guardian willing to comply with all study related visits and follow instructions as advised by consulting physician.

Exclusion Criteria

1.Children with Epilepsy 2.Children with fixed Contractures.
3.Children with systemic diseases such as renal or cardiac disorders 4.Any orthopaedic surgery 5.Subjects received botulinum toxin injection in the past 6 months, 6.Serial casting or new orthotics within the past 3 months.
7.Initiating or increasing oral medications that affect the neuromuscular system, e.g. baclofen, diazepam, within the past 3 months.
8.Children who are presently undergoing Modified Constraint Induced Movement Therapy(m-CIMT).

Primary Outcome Measures

Name	Time	Method
Spasticity by Modified Ashworth scale	Baseline,1st month,2nd month, 3rdmonth and 2 months after completion of study

Secondary Outcome Measures

Name	Time	Method
1.Range of movement (ROM) by goniometry	2.Muscle strength using handheld dynamometer (wherever possible)

Locations (1): All India Institute of Medical Sciences (AIIMS)
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences (AIIMS)
🇮🇳South, DELHI, India
Dr Gautam Sharma
Principal investigator
01126549326
drsharmagautam@gmail.com