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Completed

NCT Number: NCT04611360

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.

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Key information

Conditions

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

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2020
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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