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

October 26, 2020 updated by: Riphah International University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is characterised as sudden onset of neurological dysfunction of central anxious framework that contain cerebral infarction, intra cranial haemorrhage & subarachnoid haemorrhage. Around the globe stroke is the chief cause of incapacity and passing.

The trans-cranial direct current stimulations (tDCS) could be a non-invasive,low cost and capable brain stimulator utilised within the treatment of brain disorders.Two modes of tDCS is utilised is stroke patients,anodal stimulation (increased in excitability) of the lesional half of the globe and cathodal stimulation (decreased in excitability) of the contralesional hemisphere. The transcranial direct current stimulation induced polarity-dependent changes in membrane excitability, with Anodal-tDCS causing depolarisation and cathodal-tDCS causing hyper polarization of membrane potential in neurons of the stimulated area.

The role of Trans-cranial Direct Current Stimulation as a catalyst of recovery in stroke population and found that it's a safe,portable,non invasive brain stimulation technique. T-DCS is able to modulate the excitability of specified brain areas by varying the neuronal membrane potentials that based on the polarity of the current transmitted through the scalp via sponge electrodes. Trans-cranial direct current stimulation is clinically potential for use in stroke recovery because of its ease of use, non invasive-ness and safety.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Pakistan Railway General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Anodal Transcranial Direct Current Stimulation Group
Anodal Transcranial Direct Current Stimulation and Conventional training exercises
Other: Anodal Transcranial Direct Current Stimulation Group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale
Time Frame: 6 week
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
Time Frame: 6 week
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
Time Frame: 6 week
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:
Time Frame: 6 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2019

Primary Completion (ACTUAL)

June 10, 2019

Study Completion (ACTUAL)

July 30, 2019

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (ACTUAL)

November 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rec/00502 Sundus Akhtar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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