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Efficacy of Ayurveda Therapeutic Regimen versus Physiotherapy in Post Stroke Rehabilitation - A Randomized controlled trial

Phase 3
Conditions
Health Condition 1: G968- Other specified disorders of central nervous system
Registration Number
CTRI/2023/04/051853
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Change in Barthel Index (BI) <br/ ><br>2.Changes in cognitive status assessed by the Montreal Cognitive Assessment scale (??? ?) <br/ ><br> Timepoint: Baseline, 21st , 45th, 60th, 75th day
Secondary Outcome Measures
NameTimeMethod
1.Change in Fugl Meyer Assessment (FMA) <br/ ><br>2.Change in Action Research Arm Test (ARAT) Scale <br/ ><br>3.Changes in spasticity severity assessed by Modified Ashworth Scale <br/ ><br>4.Change in Stroke Impact Scale (SIS-16) <br/ ><br>5.Change scores of Functional independent measure (FIM) <br/ ><br>6.Change in scores of Mini Mental State Examination (MMSE) <br/ ><br>7.Adverse events <br/ ><br>Timepoint: Baseline, 21st , 45th, 60th, 75th day
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