| CTRI Number |
CTRI/2024/03/064866 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| 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
|
Effect on tone and function of rTMS to the ipsilateral cortex along with standard physiotherapy on contralateral side in hemiplegia after stroke |
|
Scientific Title of Study
|
Efficacy of rTMS on ipsilateral cortex along with standard physiotherapy protocol to the contralateral side on tone and function in subacute Stroke survivors- 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 |
Pallavi Harjpal |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research
Sawangi, Meghe
Centre of Neurosciences, Acharya Vinobha Bhave Rural Hospital, Sawangi, Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9438681990 |
| Fax |
|
| Email |
pallaviharjpal26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi Harjpal |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research
Sawangi, Meghe
Centre of Neurosciences, Acharya Vinobha Bhave Rural Hospital, Sawangi, Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9438681990 |
| Fax |
|
| Email |
pallaviharjpal26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Harjpal |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research
Sawangi, Meghe
Centre of Neurosciences, Acharya Vinobha Bhave Rural Hospital, Sawangi, Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9438681990 |
| Fax |
|
| Email |
pallaviharjpal26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education and Research, D.U., Sawangi, Meghe,
Wardha, Maharashtra, 442007 |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Datta Meghe Institute of Higher Education and Research, D.U., Sawangi, Meghe,
Wardha, Maharashtra, 442007
|
| 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 Pallavi Harjpal |
Ravi Nair Physiotherapy College |
Ground Floor, Physiotherapy OPD, Room no-3,
Datta Meghe Institute of Higher Education and Research, D.U.,
Sawangi, Meghe,
Wardha, Maharashtra
Wardha
MAHARASHTRA |
9438681990
pallaviharjpal26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, DMIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G468||Other vascular syndromes of brainin cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo rTMS protocol and Standard physiotherapy |
Participants will recieve placebo Intermittent theta burst stimulation ( iTBS) parameters were based on
the standard ITBS protocols (20 minutes) along with standard physiotherapy (20 minutes) for 5 days per week for 4 weeks. |
| Intervention |
rTMS protocol and Standard physiotherapy |
Participants will recieve Intermittent theta burst stimulation ( iTBS) parameters were based on the standard ITBS protocols (20 minutes) along with standard physiotherapy (20 minutes) for 5 days per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A cerebrovascular illness diagnosed by CT or MRI, Unilateral, primary, or prior onset without lingering neurological impairment, with MAS score less than 2 and Brunnstrom stage between 2-4 in the sub-acute phase of stroke. |
|
| ExclusionCriteria |
| Details |
A familial history of epilepsy, and the use of drugs that induce seizures with a decline in or failure of the respiratory, cardiovascular, urinary, and
other major systems. Significant communicative and cognitive impairments that prevent patients from participating in assessment and treatment. Posterior circulation infarction. Restrictions associated to TMS, such as metal implants, medication delivery systems, insulin pumps, aneurysm clips (except from titanium alloy, which is non-paramagnetic), and metal implants within the body. Cervical spinal instability and severe cervical stenosis are components of severe cervical spondylosis. Claustrophobic patients
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Ashworth scale
Stroke Rehabilitation Assessment of Movement |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional reach test
10-minute walk test |
Baseline and 4 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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
The purpose of
this study is to assess and evaluate the effects of applying slow-frequency
repetitive transcranial magnetic stimulation (rTMS) to the unaffected
hemisphere to decrease interhemispheric inhibition of the lesioned hemisphere
in combination with standard physiotherapy protocol to subacute stroke
patients’ muscle tone, overall body function, functional reach, and gait
velocity. To compare how effective various interventions
are, the data will be gathered and examined.
|