A Randomized controlled trial to evaluate the efficacy of ‘Ayurvedic management protocol’ and Physiotherapy in functional improvement of Spastic Cerebral Palsy affected children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 1. Reduction in spasticity and increased use of muscle groups for activity of daily living
研究概览
简要总结
Cerebral Palsy is a group of permanent disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The Global incidence of CP is 3.6 per 1000 live births. The prevalence of Spastic Cerebral Palsy in children in India is 2.95 per 1000 live children. Its worldwide incidence is 2 to 2.5 per 1000 live births.5,6 while in India it is 2-4 per 1000 live birth. Clinical manifestation of Spastic Cerebral palsy is similar to Vata Vyadhi. Therefore in practice it is managed on the same line by Ayurvedic physicians. Basti Chikitsa and use of Rasayana drugs are the treatment of choice for vatavyadi. Ayurvedic interventions in cerebral palsy on the line of Vata Vyadhi, have given effective results. However very limited RCTs are available on the same. The high incidence of CP, less parent satisfaction for allopathic management, there is acute need of randomized controlled trial. Considering the same this present study has been planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of either sex having Spastic cerebral palsy .
- •Cases between age group 1 year to 10 years of either gender.
- •Either parent should be willing and capable of following instructions.
排除标准
- •Patients undergoing any other allopathic medication.
- •Patients associated with severe or profound mental retardation.
- •Children with fixed contractures and deformities affecting stature and gait.
- •Children with acute or chronic illness that can interfere the intervention.
- •Any other condition, which as per the investigator would jeopardize the outcome of the trial.
结局指标
主要结局
1. Reduction in spasticity and increased use of muscle groups for activity of daily living
时间窗: Baseline | 30 days | 60 days | 90 days
2. Attaining of motor milestones
时间窗: Baseline | 30 days | 60 days | 90 days
次要结局
- improvement in quality of life(90 days)