| 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
|
|
|
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
|
|
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. |