Efficacy of Ayurveda Therapeutic Regimen versus Physiotherapy on Functional Disability and QoL in Post Stroke Rehabilitation - A prospective Randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Change in Barthel Index (BI)
研究概览
简要总结
This study is designed as a randomized controlled clinical trial to compare the efficacy of an individualized Ayurvedic therapeutic regimen and Physiotherapy in Post-stroke rehabilitation. Individualised Ayurvedic Therapeutic regimen will be administered to Group I patients. They will be admitted in NARIP Hospital for 45 days for IP treatment, followed by OPD treatment for 30 days. Total study duration is 75 days in both groups.
Patients enrolled in group II will be admitted in NARIP Hospital initially for 14 days. During this period, a qualified physiotherapist will train the subjects daily for 2 sessions in the morning and evening, with a duration of 45 – 60 minutes per session. Set of exercises will be selected depending on the subject’s condition and response, as appropriate and will be advised to the patient for daily home based physio therapy sessions (Two sessions daily – each of 45-60 minutes duration) at the time of discharge (14th day) and during each follow up visit. (On 21st, 45th, 60th and 75th day)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients in the age group 30-70 years, with a radiological diagnosis of stroke (chronicity ≥ 3 months but less than 2 years) 2.Subjects with cognitive and/or motor deficits following stroke 3.Ability to follow instructions and perform the study tasks as per the protocol.
排除标准
- •1.Participants with a history of multiple strokes, seizures associated with the index ischemic stroke, paralysis/weakness of whole body or global aphasia 2.Current or chronic history of liver or renal diseases, dementia, other neurological disorders such as epilepsy, cerebellar ataxia etc 3.Severe cognitive deficit (MMSE ≤9 point) 4.Hypertension (> 160/100 mm Hg), with or without medication 5.Current or previous history of congestive heart failure, atrial or ventricular arrhythmias, including atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, and Wolff-Parkinson-White syndrome or electrocardiographic findings 6.Uncontrolled diabetes mellitus (HbA1c ≥8%) 7.Any condition that in the view of the investigator would put the patient at risk through participation in the study.
结局指标
主要结局
1.Change in Barthel Index (BI)
时间窗: Baseline, 21st , 45th, 60th, 75th day
2.Changes in cognitive status assessed by the Montreal Cognitive Assessment scale (МоСÐ)
时间窗: Baseline, 21st , 45th, 60th, 75th day
次要结局
- 1.Change in Fugl Meyer Assessment (FMA)(2.Changes in spasticity severity assessed by Modified Ashworth Scale)