Development, content validation and feasibility testing of an integrative yoga and ayurveda(IYA) therapy for post-stroke rehabilitation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale, Modified Ashworth scale, Modified Barthel Index, Berg balance scale, 10 meter walk test
研究概览
简要总结
This study aims at developing, validating, and testing efficacy of an add on Integrated Yoga and Ayurveda (IYA) therapy program for post-stroke rehabilitation at the National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru. With stroke being the second leading cause of death globally and a major cause of disability, there is a pressing need for holistic rehabilitation interventions.
The study employs a two-part methodology: first, developing and validating the IYA protocol through mixed methods research, and second, conducting a randomized controlled pilot study to test its feasibility. The protocol development phase involves thorough literature review of classical and modern texts, interviews with experienced practitioners, and expert validation using case summaries. The pilot study involves 60 participants (30 in each arm) who meet specific inclusion criteria, including being at least three weeks post-stroke and having sufficient cognition to follow commands.
The intervention combines specific yoga practices with traditional Ayurvedic treatments (including Shiropichu, Abhyanga Sveda, and Basti) over a 23-day period. The experimental group will receive this integrated therapy alongside standard care, while the control group will receive standard care alone. The study will measure multiple outcomes using validated assessment tools, including the Modified Rankin Scale for disability, 10 Meter Walk Test, Modified Ashworth Scale for spasticity, Berg Balance Scale for balance assessment, and Hospital Anxiety and Depression Scale for psychological well-being.
This research is particularly significant as it attempts to bridge traditional Indian healing systems with modern rehabilitation approaches. The integration of Yoga and Ayurveda offers potential benefits beyond physical rehabilitation, addressing psychological and quality-of-life aspects that are often overlooked in conventional stroke rehabilitation.
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
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Cerebrovascular event due to arterial stroke both ischemic and hemorrhagic strokes patients, aged over 18 years, First episode of stroke, 3 weeks of post-stroke, Modified Rankin Scale (mRS) scores of 2 to 5 at the time of enrolment, Sufficient cognition to follow instructions.
排除标准
- •Altered sensorium, Severely aphasic to comprehend simple instructions, Bladder or bowel incontinence, Patients with Cardiovascular disorder and Chronic Kidney Disorder, Patients with Pulmonary dysfunction.
结局指标
主要结局
Modified Rankin Scale, Modified Ashworth scale, Modified Barthel Index, Berg balance scale, 10 meter walk test
时间窗: On the day of enrolment under study, Followup at 3 months
次要结局
- Visual analogue scale (VAS)(On the day of enrolment under study, Followup at 3 months)
- Hospital Anxiety and Depression Scale (HADS)(On the day of enrolment under study, Followup at 3 months)
- Thermography assessment(On the day of enrolment under study, Followup at 3 months)
- Yoga Performance Assessment (YPA)
研究者
Tarana Parida
National Institute of Mental Health and Neurosciences