Content Validation And Feasibility Of An Integrated Yoga And Ayurveda Based Intervention for Autism Spectrum Disorder
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Autism Treatment and Evaluation Checklist ( ATEC)
研究概览
简要总结
Autism Spectrum Disorder(ASD) remains to de one of the lifelong disorders which doesn’t have a definitive cure. This causes lot of distress in child as well as the care givers with significant deterioration in their quality of life. The conventional therapies also has limited evidence in treating these children. Yoga therapy in the recent times has shown to have promising results in terms of improving several domains of ASD if done systematically and regularly for a long term. Similarly Ayurveda has also shown efficacy in few reported case studies. However, a combined modality of treatment including both components of Yoga and Ayurveda has been sparse.
Objective: To validate safe and feasible Integrated Yoga and Ayurveda Module (IYAM) for autism spectrum disorder with an objective of improving physical, social and emotional disturbances in ASD children and to test the feasibility IYAM .
NULL HYPOTHESIS:
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The developed integrated module will not be safe and feasible for practice in patients suffering from ASD in a pilot study.
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The developed integrated yoga and Ayurveda module will not have positive effect on physical, social and emotional disturbances in ASD children
ALTERNATE HYPOTHESIS:
-
The developed integrated module will be safe and feasible for practice in patients suffering from ASD in a pilot study.
-
The developed integrated yoga and Ayurveda module will have positive effect on physical ,social and emotional disturbances in ASD children (with specific regards to social communication and restricted repetitive behaviours, sleep disturbances, GI disturbances sensory impairments
Design: Open label pilot study
Setting: The trial will be conducted in NIMHANS Integrate Centre for Yoga, NIMHANS.
Subjects: Subjects aged 10 years to 18 years both male and female diagnosed as ASD, satisfying the inclusion criteria would be included in the study.
Interventions: An Integrated Yoga and Ayurveda Management Program will be administered.
Assessments: Autism Treatment Evaluation Checklist (ATEC), Composite Sleep Disturbance Index(CSDI), Gastrointestinal Severity Index(GSI), Yoga Performance Assessment(YPA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 10.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Social quotient- above 60% Diagnosis of Autism according to DSM 5, INCLEN Diagnostic Tool Children with mild autism Children with or without aggression Children with or without ADHD Parents education.
- •Metric Children with or without Psychotropics.
排除标准
- •Neurological disorders of known etiology Significant sensory or motor impairment Major physical abnormalities History of head injuries Children in any neurotrophic medications.
结局指标
主要结局
Autism Treatment and Evaluation Checklist ( ATEC)
时间窗: At baseline and after 3 weeks of intervention
次要结局
- Composite sleep disturbance index (CSDI)(Gastrointestinal severity Index (GSI))