Evaluation of reflexology as an adjunctive therapy in children with refractory Childhood Epilepsy including West Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
This study is a randomized controlled (open-label) trial. In this study, eligible children will be randomized to either receive adjunctive reflexology therapy along with the on-going standard therapy with anti-epileptic medications (intervention arm), or continue to receive the standard therapy with on-going antiepileptic medications (control arm). In both phases there will be a baseline period of 1 week. The baseline period will begin with a screening visit during which investigators obtain informed consent, assessed entry criteria, and performed screening procedures. These procedures included a complete physical and neurologic history and examination (pulse, blood pressure, and body weight) and laboratory testing (blood chemistry, hematology, urinalysis, and pregnancy test if appropriate). Patients or their parents or legal guardians maintained a diary in which they recorded spasm type and frequency. These diaries were reviewed, and the baseline seizure frequency will be calculated. Patients who complete the baseline period and still meet eligibility criteria enter into the treatment period. The treatment period was composed of a 4-week up-training period and an 8-week continuation period. This will be followed by a 1 week assessment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 6 months to 12 years
- •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.
- •Residents of Delhi/National capital region.
排除标准
- •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 <7.2), hypoglycemia (blood sugar <40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
- •2.Motivational or psychosocial issues in the family which would preclude compliance.
- •3.Systemic illness- chronic hepatic, renal or pulmonary disease.
结局指标
主要结局
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.
时间窗: 3 months
次要结局
- 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.)