Anodal Transcranial Direct Current Stimulation on Mobility and Balance in Post Stroke Patients.

NCT04611360 | Completed DMC

• 1 other identifier: Rec/00502 Sundus Akhtar
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effects of anodal transcranial direct current stimulation on mobility and balance in post stroke patients.

Conditions

Stroke

Keywords

Balance; Stroke; Anodal Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (4)

• Modified Rankin Scale

  It is commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disorders.The scale runs from 0-6,running from perfect no symptoms to death.The inter rater reliability of Modified Rankin Scale (MRS) for stroke is (0.95)

  6 week

• Dynamic Gait Index

  Dynamic Gait Index (DGI) was to evaluate functional stability in older people and to evaluate their risk of falling.Its a 4 point ordinal scale,ranging from 0-3, "0" indicates the lowest level of function and "3" indicates the highest level of function.The inter rater reliability of DGI for stroke is (0.96)

  6 week

• 10 Meter Walk Test

  It is to be used for gait speed assesment.According this,individual walk without assistance 10 meters and the time is measured for the intermediate 6 meters. The reliability of 10 meter walk test is (0.97)

  6 week

• Fugl Meyer function test:

  Fugl Meyer Function (FMA) is used to assess voluntary movements,reflex activity,grasping and co-ordination of affected limb in stroke.It contain 33 task with a scale of 0-2 with maximum scoring of 66.The reliability of FMA scale is (0.95-1)

  6 week

Study Arms (2)

Anodal Transcranial Direct Current Stimulation Group

EXPERIMENTAL

Anodal Transcranial Direct Current Stimulation and Conventional training exercises

Other: Anodal Transcranial Direct Current Stimulation Group

Conventional Training Exercises Group

ACTIVE COMPARATOR

Conventional Training Exercises : Bridging,Sitting: weight-bearing, Standing: weight-bearing, Sit to stand, Squat exercises and Tandem walk

Other: Conventional Training Exercises Group

Interventions

Anodal Transcranial Direct Current Stimulation Group OTHER

Experimental group were received anodal transcranial direct current stimulation and conventional training exercises for 3 days a weeks for 6 consecutive weeks on alternate days. Anodal tDCS were given through: i. Anodal electrode:It has been placed over primary motor cortex(ipsilesional) ii. Cathodal electrode: It has been above contralateral eye. iii. Intensity: 2mA iv Density: 0.07C/cm2 iv. Duration:20 min vi Rectangular electrodes(25cm2 ) inserted in saline soaked sponge used

Anodal Transcranial Direct Current Stimulation Group

Conventional Training Exercises Group OTHER

Conventional physical exercises were given for 3 days a week on alternate days upto 6 weeks. It includes: progressive Conventional Training Exercises : From Bridging,Sitting: weight-bearing, Standing: weight-bearing, Sit to stand, Squat exercises and Tandem walk.

Conventional Training Exercises Group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with both ischemic and hemorrhagic stroke
• Subacute and chronic stroke patients(onset of stroke from 3 months to 1 year)
• Ambulatory stroke survivors were included who met the criteria of Modified Rankin Scale between 1 and 3

You may not qualify if:

• Patients with Modified Rankin Scale of 0 and 4-6.
• Brain tumors
• Cognitive impaired
• Known case of seizures
• Metal implant, head injury etc and other disorders which contraindicate the application of anodal transcranial direct current stimulations.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (3)

• Rossi C, Sallustio F, Di Legge S, Stanzione P, Koch G. Transcranial direct current stimulation of the affected hemisphere does not accelerate recovery of acute stroke patients. Eur J Neurol. 2013 Jan;20(1):202-4. doi: 10.1111/j.1468-1331.2012.03703.x. Epub 2012 Mar 26.

  PMID: 22448901 BACKGROUND

• Iosa M, Morone G, Fusco A, Bragoni M, Coiro P, Multari M, Venturiero V, De Angelis D, Pratesi L, Paolucci S. Seven capital devices for the future of stroke rehabilitation. Stroke Res Treat. 2012;2012:187965. doi: 10.1155/2012/187965. Epub 2012 Dec 13.

  PMID: 23304640 BACKGROUND

• Fusco A, Iosa M, Venturiero V, De Angelis D, Morone G, Maglione L, Bragoni M, Coiro P, Pratesi L, Paolucci S. After vs. priming effects of anodal transcranial direct current stimulation on upper extremity motor recovery in patients with subacute stroke. Restor Neurol Neurosci. 2014;32(2):301-12. doi: 10.3233/RNN-130349.

  PMID: 24398722 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: January 10, 2019
• Primary Completion: June 10, 2019
• Study Completion: July 30, 2019
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)