| CTRI Number |
CTRI/2024/05/067787 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| 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
|
Early electrical stimulation in Acute stroke and its effect on shoulder, hand rehabilitation and blood biomarker |
|
Scientific Title of Study
|
Neuro-muscular electrical stimulation (NMES) in acute ischemic stroke rehabilitation of upper extremity and their relationship with MMP-9 and NFL- A randomized control 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 |
Shahnawaz Ahmad |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9935400891 |
| Fax |
|
| Email |
shahnawaz@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rameshwar Nath Chaurasia |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415353255 |
| Fax |
|
| Email |
goforrameshwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rameshwar Nath Chaurasia |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415353255 |
| Fax |
|
| Email |
goforrameshwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self/ Shahnawaz Ahmad, Department Of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India, 221005 |
|
|
Primary Sponsor
|
| Name |
Shahnawaz Ahmad |
| Address |
Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Prof Rameshwar Nath Chaurasia |
Banaras Hindu University |
In-patient Department, Department of Neurology Institute of Medical Sciences,
Varanasi
UTTAR PRADESH |
9415353255
goforrameshwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I634||Cerebral infarction due to embolism of cerebral arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early Neuromuscular electrical along with standard rehabilitation to acute ischemic stroke patients within 10 days on stroke onset |
Early Neuromuscular electrical stimulation will be given along with standard rehabilitation to acute ischemic stroke patients within 10 days on stroke onset |
| Comparator Agent |
standard Rehabilitation only for acute ischemic stroke patients |
only standard rehabilitation for acute ischemic stroke patients within 10 days of stroke onset |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
first ever stroke patients, mRS score 2-4 |
|
| ExclusionCriteria |
| Details |
hemorrhagic stroke, recurrent stroke, epilepsy, peripheral neuropathy, patients unable to follow command, cutaneous ulcer at stimulation site. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand function and shoulder subluxation |
within 10 days after stroke and 3 months after stroke |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of NMES on biomarker (NFL and MMP-9) |
within 10 days after stroke and 3 months after stroke |
|
|
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)
|
01/06/2024 |
| 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="0"
Months="4"
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
|
patients will be recruited after screening with inclusion and exclusion criteria and after obtaining informed consent form from patients or there legal representatives. patients with mRS 2-4 will be recruited in the trial. Early neuromuscular electrical stimulation will be given to patient un till discharge from neurological ward and will be given home programme and follow-up will be done at 3 months. |