Effectiveness Of Selected Ayurveda Therapeutic Procedures And Physiotherapy In The Management Of Sarvangavata Roga(Spastic Cerebral Palsy) In Children – A Controlled Clinical Trail
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Reduction in spasticity
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Open Label
Eligibility Criteria
- Ages
- 2.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Reduction in spasticity
Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks
Improved range of movement
Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks
Imrpoved gross motor function
Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks
cerebral palsy quality of life
Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks
Secondary Outcomes
- reduction of drooling