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CTRI Number  CTRI/2018/04/013178 [Registered on: 11/04/2018] Trial Registered Prospectively
Last Modified On: 28/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effectiveness of transcranial direct current stimulation (A very low current brain stimulation) on upper limb movement control in stroke patients.  
Scientific Title of Study   Efficacy of transcranial direct current stimulation (tDCS) on upper limb motor control in persons with sub-acute stroke - A randomized controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  D Subramanian 
Designation  Research Associate 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7034885388  
Fax    
Email  subupsg@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mindy F Levin 
Designation  Professor 
Affiliation  School of Physical and Occupational Therapy, McGill university 
Address  3654 Prom Sir - William - Osler, Montreal,Quebec H3G 1Y5, Canada.



H3G 1Y5
Other 
Phone  514-398-3994  
Fax  514-398-6360  
Email  mindy.levin@mcgill.ca  
 
Details of Contact Person
Public Query
 
Name  Dr John Solomon 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal MANIPAL

Udupi
KARNATAKA
576104
India 
Phone  9945670671  
Fax    
Email  johnsolomon78@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Physiotherapy, School Of Allied Health Sciences, Manipal Academy Of Higher Education, Manipal, Udupi District, Karnataka - 576104 
 
Primary Sponsor  
Name  D Subramanian 
Address  Department of Physiotherapy, School of Allied Health sciences (SOAHS), Manipal Academy of Higher Education, Manipal - 576104.  
Type of Sponsor  Other [Principal Investigator] 
 
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 
D Subramanian  Kasturba Hospital  Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 
7034885388

subupsg@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee,Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Cerebrovascular accident (Stroke),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anodal Transcranial Direct Current Stimulation   Anodal Transcranial Direct Current Stimulation Intensity - 2mA, Duration - 30 min per session, 1 session per day,5 days per week for 4 consecutive weeks. 
Comparator Agent  Sham Transcranial Direct Current Stimulation  Sham Transcranial Direct Current Stimulation Intensity - 0 mA, Duration - 30 min per session, 1 session per day,5 days per week for 4 consecutive weeks. 
 
Inclusion Criteria
Modification(s)  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Medically stable participants
2. Cortical or subcortical area lesion supplied by middle cerebral artery, Anterior cerebral artery, Posterior cerebral artery and confirmed by MRI / CT
3. Early or late subacute stage (1- 6 months)
4. Ischemic or hemorrhagic stroke
5. Arm paresis with Chedoke McMaster Arm Score of 2-6 out of 7 and Hand score of 2-6 out of 7.
6. Recurrent stroke with completely recovered previous stroke. 
 
ExclusionCriteria 
Details  1. Major neurological (other than stroke) / neuromuscular / orthopaedic problems
2.Major cognitive deficits
3.History of psychiatric disorders,seizure, migraine within last six months
4. Metal in cranium and other implants (cochlear, cardiac)
5. Skin sensitivity
6. Participants taking medications that could affect brain activity (e.g. epileptic and psychoactive drugs) 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. kinematic Analysis ( reach-to-grasp standardized Test Task)
2. Montreal Tonic stretch threshold measure (Spatial zones)
3. Chedoke Arm and Hand Activity Inventory (CAHAI- 7 Version)
4. Action Research Arm Test (ARAT)
 
0 weeks, 4 weeks and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reaching Performance Scale
2. Composite spasticity Index
3. Upper Extremity Subset of Fugl – Meyer Motor Function Assessment (UE –FMA)
4. Patient Health Questionnaire-9 
0 weeks, 4 weeks and 8 weeks 
 
Target Sample Size
Modification(s)  
Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "41"
Final Enrollment numbers achieved (India)="41" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2018 
Date of Study Completion (India) 29/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  
Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Residual upper limb paresis is one of the most common motor impairments that affect stroke survivor’s activities of daily living. Upper limb reaching movement, a necessary component for performing many tasks of daily living is affected in stroke. Reaching movement in survivors with stroke is characterized by abnormal patterns of muscle activation and limitation in joint ranges. These abnormal patterns of muscle activation and limitation in joint ranges may be due to deficits in the range of regulation of tonic stretch reflex thresholds (TSRT) of agonist and antagonist muscles. TSRT is the joint angle at which motorneuronal recruitment begins. Although various physical therapy approaches improves effective use of the arm including reaching, residual reaching movement deficits persist in persons with stroke. 

Transcranial direct current stimulation (tDCS), a non-invasive method of brain stimulation helps in enhancing neural plasticity and learning through neuromodulation and by increasing neurotransmitter, receptor and neurotrophin levels. Based on its effects on neural plasticity and learning, we hypothesize that, tDCS combined with upper limb reaching training could improve reaching ability in stroke persons by altering the spatial zones.Hence, the aim of this study is to determine the efficacy of tDCS on upper limb motor control in persons with sub-acute stroke.

This study is a double blinded randomized controlled trial. The participants in the intervention group will receive anodal tDCS along with task specific training with trunk restraint (TRTST) and the control group will receive sham tDCS along with TRTST. Both groups will receive either anode or sham tDCS in the first 30 minutes of a one hour of TRTST session per day for 5 days per week for 4 consecutive weeks. The primary outcome measures are kinematic analysis of elbow extension range during a standardized reach-to-grasp task, Spatial zones such as coactivation zone and silent zone of both agonist and antagonist using Montreal TSRT measure, Chedoke Arm and Hand Activity Inventory (CAHAI- 7 Version) and Action Research Arm Test (ARAT) and secondary measures are Reaching Performance Scale, composite spasticity Index, Upper Extremity Subset of Fugl – Meyer Motor Function Assessment (UE –FMA), Patient Health Questionnaire-9. Both primary and secondary outcome measures will be taken before the first day of the intervention, immediately after the 4 weeks of intervention and after a 1 month follow up period.


 
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