Health Condition 1: null- Refractory Childhood Epilepsy and West syndrome
Conditions
Interventions
Intervention1: Reflexology therapy: Reflexology therapy of 30 minutes duration twice a day in addition to the anti-epileptic drugs (AEDs)
Control Intervention1: Anti-epileptic drugs (AEDs) alone: Phar
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 6 months to 12 years 2. Presence of seizures persisting daily or more than 7 per week despite the adequate trial of at least three tolerated and appropriately chosen and used anti-epileptic drugs including one newer antiepileptic drug (either alone or in combination). In case of infantile spasms, epileptic spasms with the onset before 2 years of age, with or without electroencephalographic evidence of hypsarrhythmia or its variants, persisting for more than 3 weeks, at least 7 cluster per week, despite treatment with at least 2 appropriate AEDs, and any one of the following; corticosteroids or vigabatrin. 3. Residents of Delhi/National capital region.
Exclusion criteria
Exclusion criteria: 1.Known or suspected inborn error of metabolism, as evidenced by: Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination And/ or 2 or more of the following biochemical abnormalities High blood ammonia ( >80mmol/L), High arterial lactate ( >2 mmol/L), metabolic acidosis (pH 2.Motivational or psychosocial issues in the family which would preclude compliance. 3.Systemic illness- chronic hepatic, renal or pulmonary disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the efficacy of adjunctive reflexology in controlling seizures. This will be assessed by comparing seizure frequency at the end of the intervention period with the baseline seizure frequency the seizure frequency will be noted according to parental seizure charts.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in the EEG characteristics and improvement in background of epileptiform abnormalities will be noted. 2.Change in the neural development status at the end of intervention period compared with baseline, in both groups DQ will be assessed far as possible. 3.Change in AFT: Any changes in the HRV and BPV. 4.Abnormalities to be observed in the reflex areas baseline and at the end of the intervention. 5.Side effects of reflexology if any should be noticed by parental report.Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Mrs Sheffali Gulati
Dept of Biophysics
Outcome results
None listed