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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Anodal Transcranial Direct Current Stimulation Group
Conventional Training Exercises Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Balance, Stroke, Anodal Transcranial Direct Current Stimulation

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pakistan Railway General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anodal Transcranial Direct Current Stimulation Group

Conventional Training Exercises Group

Arm Description

Anodal Transcranial Direct Current Stimulation and Conventional training exercises

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

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
October 26, 2020
Last Updated
October 26, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04611360
Brief Title
Anodal Transcranial Direct Current Stimulation on Mobility and Balance in Post Stroke Patients.
Official Title
Effects of Anodal Transcranial Direct Current Stimulation on Mobility and Balance in Post Stroke Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Balance, Stroke, Anodal Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal Transcranial Direct Current Stimulation Group
Arm Type
Experimental
Arm Description
Anodal Transcranial Direct Current Stimulation and Conventional training exercises
Arm Title
Conventional Training Exercises Group
Arm Type
Active Comparator
Arm Description
Conventional Training Exercises : Bridging,Sitting: weight-bearing, Standing: weight-bearing, Sit to stand, Squat exercises and Tandem walk
Intervention Type
Other
Intervention Name(s)
Anodal Transcranial Direct Current Stimulation Group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Training Exercises Group
Intervention Description
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 Outcome Measure Information:
Title
Modified Rankin Scale
Description
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)
Time Frame
6 week
Title
Dynamic Gait Index
Description
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)
Time Frame
6 week
Title
10 Meter Walk Test
Description
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)
Time Frame
6 week
Title
Fugl Meyer function test:
Description
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)
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22448901
Citation
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.
Results Reference
background
PubMed Identifier
23304640
Citation
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.
Results Reference
background
PubMed Identifier
24398722
Citation
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.
Results Reference
background

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

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