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CTRI Number  CTRI/2020/01/022998 [Registered on: 27/01/2020] Trial Registered Prospectively
Last Modified On: 07/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of Multichannel Transcranial direct current stimulation on motor functions in stroke survivors 
Scientific Title of Study   A Study on Efficacy of Multichannel Transcranial Direct Current Stimulation on Cognitive Domains, Motor Functions of Paretic Hand and Gait in Subacute Stroke Survivors  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Midha 
Designation  Senior Research Fellow, PhD Scholar  
Affiliation  Punjabi University 
Address  Department of Physiotherapy
Punjabi University
Patiala
PUNJAB
147001
India 
Phone  8607556615  
Fax    
Email  divyamidha.pt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Narkeesh Arumugam 
Designation  Professor and Head 
Affiliation  Punjabi UNiversity, Patiala 
Address  Department of Physiotherapy

Patiala
PUNJAB
147001
India 
Phone  9417802662  
Fax    
Email  narkeesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Narkeesh Arumugam 
Designation  Professor and Head 
Affiliation  Punjabi UNiversity, Patiala 
Address  Department of Physiotherapy

Patiala
PUNJAB
147001
India 
Phone  9417802662  
Fax    
Email  narkeesh@gmail.com  
 
Source of Monetary or Material Support  
Punjabi University, Patiala, Punjab (147001) 
 
Primary Sponsor  
Name  Punjabi University 
Address  Department of Physiotherapy Punjabi University, Patiala, Punjab 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Narkeesh Arumugam   Punjabi University  Outpatient Department, Department of Physiotherapy
Patiala
PUNJAB 
9417802662

narkeesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multi channel tDCS   Multi channel (tDCS) +Functional Electrical Stimulation +Saebo Flex+ Conventional Rehabilitation 4 weeks  
Comparator Agent  Sham Multichannel tDCS  sham Multi channel (tDCS) + Functional Electrical Stimulation+Saebo Flex+ Conventional Rehabilitation 04 weeks  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Subacute stroke survivors.
2.Males and females
3.Individuals of the age group (40- Years).
4.Modified Ashworth Scale Score < 2
5.Preserved Range of Wrist Extension (≈10 Degrees).
6.Individuals who are able to walk
7. Individuals with mild cognitive Impairment Mini Mental State Examination (MMSE) Score (18-23).
8.Individuals, who are willing to participate in the study.


 
 
ExclusionCriteria 
Details  1.Individuals diagnosed with hemorrhagic stroke
2.Individuals with a history of neurological disease other than stroke.
3.Individuals with a history of musculoskeletal injury/disease affecting upper Extremity and lower extremity.
4.Individuals with Psychosomatic Illness/ Disease.
5.Individuals with severe cardiovascular & respiratory problem
6.Individuals with uncontrolled hypertension
7.Individuals with any systemic illness.
8.Pregnant women
9.Individuals with metallic Implants.
10.Visual analog scale for pain score >4 in the upper Extremity/lower extremity.
11.Participation in other pharmacological & rehabilitation studies during the study period.
12.Individuals with hypersensitivity or hypoensitivity disorders.
13.Non Cooperative Individuals.



 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Fugl Meyer Assessment
Electroencephalography
 
04 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Montreal Cognitive Assessment
Nine Hole Peg Test
Grip Strength
Pinch Strength
Wisconsin gait scale
Stroke Specific Quality of Life scale
tDCS adverse effect questionnaire
 
04 Weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   31/01/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Protocol Publication Case Study Publication Case Series Publication Systematic Review Publication Complete study Publication 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Need of the study

       There has been a long standing view that motor recovery remains incomplete and many post stroke survivors live with disability throughout their life. Despite extensive exercise training and efforts, most of the neurorehabilitation (exercise training and task based intervention) models induce motor learning by “symptoms- based” approach in which these therapeutic approaches devote maximum emphasis on the motor learning with minimum focus on the cognitive domains.  As evidenced in the literature, Cognitive impairments may coexist with motor impairments and cognitive deficits may significantly alter the motor performance of affected individuals affecting their functional recovery.

       Secondly, Reacquisition of motor functions also depends on interhemispheric motor circuits in the cerebral hemispheres. Motor recovery after stroke is related to neural plasticity, which refers to the ability of the brain to develop new neuronal interconnections, acquire new functions, and compensate for the impairment. The challenge for obtaining good recovery is to optimally utilize the broad spectrum intrinsic capacity of the brain in modulating viable neuronal networks and to provide intervention strategies for complete compensation of the loss due to injury to the brain. But Despite the implementation of novel therapeutic approaches, sometimes the effect size of single intervention is not sufficient enough to induce complete recovery; hence affected individuals live with the residual disabilities for the rest of their life.

       Thirdly, Electrical interventions in the form of  (tDCS) has been found to be a promising tool for adding therapeutic benefits in post stroke rehabilitation with  its qualities of ease in application, safety and cost effectiveness and no adverse effects to the individuals. In Most of trials, the (tDCS) has been successively applied to the different cortical areas targeting the motor and cognitive deficits in isolation and at different point of time to yield the potential outcomes but, on the other side very little is known about the multi-target stimulation  of the cortical areas through (tDCS). There is huge scarcity of literature regarding clinical application of Multichannel transcranial direct current stimulation in subacute stroke survivors targeting the cognitive and motor functions simultaneously. Hence, there is a strong need to overcome the existing limitations in our current post stroke rehabilitation interventions and to utilize the integrated approach by targeting multiple areas taking into account the functional connectivity of cortical networks in respective functions.  Hence the present study aims to find out the efficacy of multi channel (tDCS) on cognitive domains, motor functions of paretic hand and gait in subacute stroke survivors.

Aim of the Study

To determine the efficacy of Multi Channel (tDCS) on Cognitive Domains, Motor Functions of Paretic Hand and Gait in Subacute Stroke Survivors.

Objectives of the Study

To determine the  Effect of Multi Channel (tDCS) in combination with Functional electrical stimulation (FES), Saebo FlexTM and conventional rehabilitation on Cognitive Domains, Motor Functions of Paretic Hand and Gait in individuals with subacute Stroke.

  1. On motor impairment of hemiplegic side, measured through Fugl Meyer Upper extremity Scale. 

  2. On motor Functions of paretic hand i.e Grip strength and pinch strength, measured through Hand Dynamometer and Pinch Gauge respectively . 

  3. On dexterity functions of paretic hand, measured through Nine Peg hole test (NPHT).

  4. On Cortical changes measured via EEG (Electroencephalogram).

  5. On Cognitive domains, measured through Montreal cognitive assessment scale.

  6. On locomotor function, measured through Wisconsin Gait scale.

  7. On quality of life following stroke, measured through Stroke specific quality of life scale 

To determine the adverse effects of (tDCS) using (tDCS) adverse effect questionnaire

METHODOLOGY

The present study will be a prospective randomized controlled clinical trial.  Participants will be selected based on the sample selection criteria and will be randomly allocated into two independent   groups i.e Experimental Group (Group A) and Control Group (Group B) .

Ethical approval for the present study has been taken from the Institutional Ethical Committee, Punjabi University, Patiala.

Written consent will be taken from all the participants, willing to participate,  prior to the commencement of the study.

Subacute Stroke Survivors with the age Group (50-80 years) will constitute the Population of the study. The participants will be selected from Various Physiotherapy/rehabilitation Centres /Hospitals in and around Punjab. .  

G Power software was used for sample size calculation.

The final sample size calculated to be 60, with (n=30) in each group

Baseline Assessment will be done for outcome measures of the study EEG, NHPT,

Grip Strength, Pinch strength, WGS, FMA, MOCA &  SS-QOL

Random allocation of Participants 

Group A(Experimental Group- Multi channel tDCS) +FES+Saebo Flex+ Conventional Rehabilitation for 5 sessions/week for 4 weeks

Group B (Control Group) - sham Multi channel tDCS) +FES+Saebo Flex+ Conventional Rehabilitation for 5 sessions/week for 4 weeks

Post Intervention assessment will be done Day 15 and Day 30 for outcome measures of the study: EEG, NHPT, Grip Strength, Pinch strength, WGS, FMA, MOCA & SS-QOL

Data will be collected

Statistical analysis will be done








 
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