Evaluation of Agnikarma in management of spasticity in children with spastic cerebral palsy - a randomised controlled clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ayurveda intervention by Agnikarma is known to reduce spasticity when measured on Modified Tardieu scale and
研究概览
简要总结
Cerebral palsy is a neuromotor disorder that affects the development of movement, muscle tone and posture. The motor disorders of Cerebral Palsy are often accompanied by disturbances of sensation, perception, cognition, communication, and behavior,as well as epilepsy and secondary musculoskeletal problems.. The prevalence of Cerebral Palsy is estimated to be between 2 to 3 cases per 1000 live births. Among the different types of Cerebral Palsy, Spastic Cerebral Palsy is the most frequent subtype, making up a significant proportion of approximately 70% to 80% of all cases. . The global incidence of Cerebral Palsy is 2:1000. In India the incidence of cerebral palsy is 3 per 1000 live birth.. The primary problems associated with spasticity are loss of balance, strength, and selective motor control of the muscles, and increased muscle tone which leads to problems such as fixed contractures and bony deformities that cause severe motor dysfunction in patients .
In conventional medicine, treatments like Baclofen, Benzodiazepines, and Tizanidine, when administered over an extended period, can lead to side effects such as fatigue, hypotension, muscle rigidity, impaired mental status, hyper pyrexia, drowsiness, and potential Hepato toxicity.Tendon Lengthening Procedures are also used but this procedure is critical and on time the lengthened muscle gets weakened.
The Ayurveda diagnosis of this condition can also be linked to "Snayugata Vikara Vatavyadhi," where an imbalance of Vata and Kapha Doshas may result in symptoms such as Sthambha, Kampa, Sula, And Akshepa. There is a need today to find a protocol that works locally to help children with cerebral palsy to relieve spasticity. In Ayurveda different treatment modalities are mentioned for Vatavyadhi Chikitsa , Agnikarma is one of the treatment may having role in Vata vyadhi. Hence this study is taken for management of spasticity in children having cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Children of either sex in age group between 5 years-16 years.
- •â€¢ Children fulfilling the diagnostic criteria.
- •â€¢ Children who have not received any form of modern intervention for spasticity at least for last 1 month.
排除标准
- •â€¢ Children with non-spastic Cerebral Palsy will be excluded.
- •â€¢ Children with any known major congenital anomalies like Congenital Heart Disease (CHD) etc.
- •will be excluded.
- •â€¢ Children with other disease status like Acute infections, severe systemic illness and children with any progressive neurologic anomalies will be excluded.
- •â€¢ Children with any other diseases or any other drugs that may interfere with the study outcome will be excluded.
- •â€¢ Children under gone any surgery intervention for spasticity will be excluded.
- •â€¢ Children having local inflammation or skin lesion on the site of spasticity will be excluded.
结局指标
主要结局
Ayurveda intervention by Agnikarma is known to reduce spasticity when measured on Modified Tardieu scale and
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Composite spasticity index
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次要结局
- Ayurveda intervention by Agnikarma is known to reduce spasticity when measured on Range of motion by Universal Goniometry
研究者
DR JEERU OJASWINI REDDY
KLE Shri B.M. Kanakanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka