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

Phase 2
Conditions
Health Condition 1: G80- Cerebral palsy
Registration Number
CTRI/2019/10/021678
Lead Sponsor
Centre for Integrative Medicine and Research CIMR
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. 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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Spasticity by Modified Ashworth scaleTimepoint: Baseline,1st month,2nd month, 3rdmonth and 2 months after completion of study
Secondary Outcome Measures
NameTimeMethod
1.Range of movement (ROM) by goniometry <br/ ><br>2.Muscle strength using handheld dynamometer (wherever possible) <br/ ><br>3.Gross motor function by GMFCS E&R <br/ ><br>4.Cognition and Behaviour by Developmental Profile -3 and Child Behaviour Check List (CBCL) <br/ ><br>5.Quality of Life by Ped. QOL inventory <br/ ><br>Timepoint: Baseline,1st month,2nd month, 3rdmonth and 2 months after completion of study
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