akwa ke baad patients ke balance & chal (gait) par exercise ke sath sath dawa (fluoxetine) awam device (tDCS) ka prabhav

Phase 1

Completed

• Conditions: Health Condition 1: null- Stroke, Post stroke Impairment of Postural Satbility & Gait

• Registration Number: CTRI/2017/05/008668
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 224

Inclusion Criteria

1. First-time ischemic or hemorrhagic stroke as diagnosed by CT/MRI

2. Ischemic or hemorrhagic stroke between 1 to 6 months from the index event that has caused hemiparesis, as examined and/or confirmed by medical records.

3. Able to stand with support

4. Both gender; age >= 18 years and <= 75 years

5. Conscious and comprehensible

6. Subjects need to be able to provide informed consent.

Exclusion Criteria

1. Stroke patients < 18 years and > 75 years

2. Patient with any disability other than stroke that would preclude gait training,

3. Taking antidepressant drugs two weeks before inclusion

4. Patients taking any other selective serotonin reuptake inhibitors (SSRI) at the time of enrollment or two weeks before inclusion.

Patients taking any other medication likely to have adverse interaction with SSRIs

Flaccid hemiplegia

8. Taking neuroleptic drugs or benzodiazepines 2 weeks before inclusion

9. Other major diseases with life expectancy <= 3 months.

10. Any uncontrolled health condition for which exercise is contraindicated,

11. Any neurologic or orthopedic diseases that might interfere with the study,

12. Metallic implant within the brain

13. Epilepsy

14. Cardiac pace maker

15. Cognitive impairments

16. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gait Analysis variables and FMA-LETimepoint: At Baseline, After 6 Weeks, and After 12 Weeks

Secondary Outcome Measures

Name	Time	Method
1.NIHSS <br/ ><br>2.Modified Rankin scale (mRS) <br/ ><br>3. Modified Ashworth Scale (MAS) <br/ ><br>4. Berg Balance Scale (BBS) <br/ ><br>5. Time Up and Go Test (TUG) <br/ ><br>6. Functional Reach Test (FRT) <br/ ><br>7. Modified Barthel Index (mBI) <br/ ><br>Timepoint: At baseline, After 6 Weeks, And After 12 Weeks