| 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
|
|
|
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
|
|
|
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. On motor impairment of hemiplegic side, measured through Fugl Meyer Upper extremity Scale. On motor Functions of paretic hand i.e Grip strength and pinch strength, measured through Hand Dynamometer and Pinch Gauge respectively . On dexterity functions of paretic hand, measured through Nine Peg hole test (NPHT). On Cortical changes measured via EEG (Electroencephalogram). On Cognitive domains, measured through Montreal cognitive assessment scale. On locomotor function, measured through Wisconsin Gait scale. 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
|