A Clinical trial to study the effect of selected Ayurveda procedures & physiotherapy in spastic cerebral palsy

Phase 2/3

Not yet recruiting

• Conditions: Cerebral palsy, unspecified. Ayurveda Condition: SARVANGAROGAH/SARVANGAVATAHÂ (KEVALAVATA), (2) ICD-10 Condition: G809||Cerebral palsy, unspecified. Ayurveda Condition: SARVANGAROGAH/SARVANGAVATAHÂ (KEVALAVATA),

• Registration Number: CTRI/2023/10/059262
• Lead Sponsor: Dr Suneetha.R

Brief Summary

This study is a open label double arm, prospective, controlled clinical trail to evaluate the effectiveness of selected ayurveda therapeutical procedures with physiotherapy in the management of spaticity in cerebral palsy children 0f 2 to 10 years

20 subjects fulfilling inclusion criteria, attending kaumarabhritya outpatient department and in patient department of SDMIAH, Bengaluru will be taken in study group.

20 subjects fulfilling inclusion criteria , attending physiotherapy out patient department of SDM physiotherapy college Dharwad will be controlled group respectively.



for study group - abyanga with rasa taila, parisheka with dasamoola kashaya , basti with rasa taila quantity according to priscribed age, masha godhumdhi upnaha for affected limbs and kati done for 15 days 3 sittings

15 days of gap between each sitting, continue physiotherapy at home as adviced



for control group - paediatric physiotherapist adviced physiotherapy done for 15 days , 3 sittings, 15 days gap in between sitting. continue home phyiotherapy excercises as taught



The primary outcome measures - reduction in spasticity, increase in joint range of motion, improved mile stone will be assessed using modified ashworth scale for spasticity, goniometer for range of motion, ICD - mile stone grading, manual muscle power testing.

The secondary outcome measures - improvement of chewing, reduced drooling, improved quality  of life , improved activity of daily leaving

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-27
• Study Start: 2023-11-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Children of either gender aged between 2-10years with developmental delay and spasticity or diagnosed cases of spastic cerebral palsy 2.Children whose parents are willing to sign the informed assent 3.Diagnosed case of spastic cerebral palsy with well controlled epilepsy.

Exclusion Criteria

1.Children with uncontrolled seizure disorders 2.Children with severe contractures requiring surgical intervention 3.Children with other form of severe disability like muscular dystrophy, metabolic myopathies, genetic muscular disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cerebral palsy quality of life	0 week, 4 weeks, 8 weeks,12 weeks
Reduction in spasticity	0 week, 4 weeks, 8 weeks,12 weeks
Improved range of movement	0 week, 4 weeks, 8 weeks,12 weeks
Imrpoved gross motor function	0 week, 4 weeks, 8 weeks,12 weeks

Secondary Outcome Measures

Name	Time	Method
reduction of drooling

Trial Locations

Locations (2)

SDM Bengaluru; 🇮🇳 Bangalore, KARNATAKA, India

SDM Dharwad; 🇮🇳 Dharwad, KARNATAKA, India

SDM Bengaluru

🇮🇳Bangalore, KARNATAKA, India

Dr Suneetha R

Principal investigator

8050674912

suneeta.jrk@gmail.com