Health Condition 1: G968- Other specified disorders of central nervous system
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in Barthel Index (BI) 2.Changes in cognitive status assessed by the Montreal Cognitive Assessment scale (??? ?) Timepoint: Baseline, 21st , 45th, 60th, 75th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Fugl Meyer Assessment (FMA) 2.Changes in spasticity severity assessed by Modified Ashworth Scale 4. Change in Stroke Specific Quality of Life (SS-QoL) 4. Adverse events Timepoint: Baseline, 21st , 45th, 60th, 75th day | — |
Countries
India
Contacts
NARIP, Cheruthuruthy