| CTRI Number |
CTRI/2026/01/101562 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Transcranial Direct Current Stimulation On Cognition, Balance, Gait, And Quality Of life In Hemiplegic Patients |
|
Scientific Title of Study
|
Effect Of Transcranial Direct Current Stimulation On Cognition, Balance, Gait, And Quality Of life In Hemiplegic Patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabhat Gupta |
| Designation |
PG student |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University gurugram |
| Address |
sgt university room number 418 4th floor department of physiotherapy B block gurugram haryana 1220505 india
Gurgaon
HARYANA
122505
India |
| Phone |
7351623341 |
| Fax |
|
| Email |
Prabhatg277@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Kumar |
| Designation |
Associate professor |
| Affiliation |
sgt university |
| Address |
sgt university room number 418 4th floor department of physiotherapy B block gurugram haryana 1220505 india
Gurgaon
HARYANA
122505
India |
| Phone |
9023245955 |
| Fax |
|
| Email |
saurabh_fpt@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Kumar |
| Designation |
Associate professor |
| Affiliation |
sgt university |
| Address |
sgt university room number 418 4th floor department of physiotherapy B block gurugram haryana 1220505 india
Gurgaon
HARYANA
122505
India |
| Phone |
9023245955 |
| Fax |
|
| Email |
saurabh_fpt@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prabhat Gupta |
| Address |
Khemganj behind police station Sirsaganj district Firozabad Uttarpradesh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prabhat Gupta |
Home Care At Home Rehab Recovery Centre |
Ground Floor Gurugram Haryana
Gurgaon
HARYANA |
7351623341
Prabhatg277@gmail.com |
| Prabhat Gupta |
SGT UNIVERSITY |
SGT university Chandu Bhudhera Gurugram Haryana
Gurgaon
HARYANA |
7351623341
prabhatg277@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee of faculty of physiotherapy SGT university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Experimental Group |
TDCS FOR 20 min per session, 5 sessions in a week for 5 weeks. |
| Comparator Agent |
Control Group |
Receive a procedure designed to mimic the experimental group in all aspect for the delivery of therapeutically effective electrical current, 20 mins per session, for 5 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 year
Patients diagnosed with hemiplegia due to ischemic and hemorrhagic stroke
unilateral limb paralysis and motor dysfunction of lower limbs
MOCA above 22
MAS less than or equal to 3 in the lower limb
Both male and female patient
Ability to maintain sitting balance independently and stand with or without minimal support
Participate voluntarily and sign an informed consent formhe clinical symptoms include unilateral limb paralysis and motor dysfunction of lower limbs
Montreal cognitive Assessment
Stable state clear consciousness and no hearing and comprehension disabilities to complete the questionnaires
Participate voluntarily and sign an informed consent form |
|
| ExclusionCriteria |
| Details |
MAS less than or equal to 4
Severe cognitive impairement global aphasia or perceptual deficit
Tracheostomy patients
Patients with serious internal diseases tumors and other malignant diseases infectious diseases and mental illnesses
Contraindications for electrical stimulation devices such as with pacemakers or other implantable devices history of epilepsy or and seizures
History of head trauma or head and spinal cord surgery bleeding disorders in pregnancy or lactation or planning to become pregnant in the next 6 months injuries swelling or scarring at the skin of the stimulating sites sensory disturbance or allergy to electrical stimulation
Have taken muscle relaxant drugs in the past month or have received botulinum toxin injections in a spastic limb within the past 6months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognition
Balance
Gait |
Baseline and 5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline and 5 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke frequently causes impaired balance, gait dysfunction, cognition and decreased quality of life, all of which limit independence and increase the risk of falls. Conventional physiotherapy alone may not be sufficient to fully restore these functions. Trans cranial direct current stimulation (tdcs), a non-invasive brain stimulation therapy, has been demonstrated to promote neuroplasticity and improve motor rehabilitation. However, the evidence for its usefulness in improving balance, gait, cognition and general quality of life in stroke patients is limited and equivocal. As a result, this study is required to establish the role of tdcs as an adjuvant to rehabilitation for improved functional results. This study will provide evidence on whether combining tdcs with conventional therapy offers greater improvements in gait, balance, cognition, quality of life in hemiplegic patients, thereby guiding rehabilitation practices and enhancing patient independence and quality of life. |