| CTRI Number |
CTRI/2025/10/096061 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the effect of transcranial direct current stimulation with baclofen on muscle tightness and movement in stroke patients |
|
Scientific Title of Study
|
Combined Effects of Transcranial Direct Current Stimulation and Oral Baclofen on Spasticity and Motor Function in Patients with Spastic Hemiplegia: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghavendrasingh Dharwadkar |
| Designation |
MPT ,Assistant Professor, KAHER Institute of Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Department of Neurology Physiotherapy ,Advanced Physiotherapy Center ,Dr Prabhakar Kore Hospital and MRC , Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendrasingh Dharwadkar |
| Designation |
MPT ,Assistant Professor, KAHER Institute of Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Department of Neurology Physiotherapy ,Advanced Physiotherapy Center ,Dr Prabhakar Kore Hospital and MRC , Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Isha shah |
| Designation |
Post Graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy ,J.N.Medical College Campus, Nehru Nagar, Belgaum, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
08329896766 |
| Fax |
|
| Email |
ishashah9979@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital and medical research center ,Nehru Nagar, Belagavi , Karnataka , India 590010 |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
KLEs Dr Prabhakar Kore Hospital and medical research center ,Nehru Nagar, Belagavi , Karnataka , India 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 Raghavendrasingh Dharwadkar |
KAHER Institute of Physiotherapy |
Advanced Physiotherapy Center ,Dr Prabhakar Kore Hospital and MRC , Nehru nagar, Belagavi
Belgaum
KARNATAKA |
9886288225
raghavendrasingh@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham Transcranial direct current stimulation and Conventional Physiotherapy |
The subjects will be given detailed information about the Transcranial direct current stimulation . The sham Transcranial direct current stimulation will be given for 20 minutes , 5 times a week for 2 weeks along with conventional physiotherapy based upon the symptoms such as , stretching, strengthening exercises, roods approach, PNF etc. will be given for 40 minutes after the sham tDCS application. |
| Intervention |
Transcranial direct current stimulation , oral Baclofen and Conventional physiotherapy |
The subjects will be given detailed information about the Transcranial direct current stimulation . The Transcranial direct current stimulation will be given for 20 minutes , 5 times a week for 2 weeks along with Oral Baclofen as prescribed by the consultant neurologist and conventional physiotherapy based upon the symptoms such as stretching, strengthening exercises, roods approach, PNF etc will be given for 40 minutes after the tDCS application. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with :
All genders between the age group of 18 to 65 years of age, Who are willing to participate
Diagnosed with first time stroke Ischemic or Hemorrhagic (more than 3months)
Spasticity more than 1 plus according to Modified Ashworth Scale in atleast one major upper or lower limb muscle.
Consciousness able to follow verbal commands & no hearing disability
No other associated traumatic and non traumatic disorder of neurological, musculoskeletal and cardiac system
|
|
| ExclusionCriteria |
| Details |
Subjects with Severe cognitive impairment
Known Allergy or intolerance to Oral Baclofen drug
Pregnancy or lactation
Sensory disturbances
History of seizures or epilepsy
Presence of metal implants or electronic devices ( eg: pacemaker, cochlear implants)
Currently receiving other spasticity reducing treatment (eg: botulinum toxin , intrathecal baclofen)
Other unstable medical conditions
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Ashworth Scale
Fugl meyer assessment Scale
|
Modified Ashworth Scale to assess spasticity pre and post 2 week intervention
Fugl meyer assessment Scale
is used to assess motor function pre and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stroke Impact Scale |
Stroke Impact scale assesses physical function , emotion , memory, communication and social participation in stroke survivors pre and post intervention. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This Randomized placebo controlled interventional trail aims to evaluate the combined effect of transcranial direct current stimulation (tDCS) and oral Baclofen on spasticity and motor function in individuals with post -stroke spastic hemiplegia. Stroke is a major cause of long-term disability and spasticity significantly limits functional recovery and quality of life. Participants diagnosed with spastic hemiplegia following stroke will be randomly assigned to two groups. The experimental group will receive real tDCS, oral Baclofen, and conventional physiotherapy, while the control group will receive sham (placebo) tDCS along with conventional physiotherapy. The interventions will be administered over a period of 2 weeks. Primary outcome measures will include changes in spasticity assessed by the Modified Ashworth scale and motor function assessed by the Fugl-Meyer Assessment. Secondary outcomes will include Stroke impact scale. This study intends to investigate whether the combination of non invasive brain stimulation and pharmacological treatment provides superior outcomes compared to physiotherapy alone in managing post stroke spasticity. |