| CTRI Number |
CTRI/2024/05/066808 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on cervical spinal cord injury patients to see the recovery based on reflexes present during the first initial examination following the injury. |
|
Scientific Title of Study
|
An observational study to predict motor recovery on the basis of presence of reflexes in cases of complete paralysis of acute cervical spinal cord injury, SMS hospital, Jaipur. |
| 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. Zakira Banu |
| Designation |
Junior resident |
| Affiliation |
SMS Medical College and Attached Hospitals, Jaipur,Rajasthan |
| Address |
Department of Physical Medicine and Rehabilitation, SMS Medical College and Attached Hospitals, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
09083591335 |
| Fax |
|
| Email |
zhamza1101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mahesh Kumar Meena |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical College and Attached Hospitals, Jaipur,Rajasthan |
| Address |
Department of Physical Medicine and Rehabilitation, SMS Medical College and Attached Hospitals, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
09828373677 |
| Fax |
|
| Email |
maheshbagdi1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mahesh Kumar Meena |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical College and Attached Hospitals, Jaipur,Rajasthan |
| Address |
Department of Physical Medicine and Rehabilitation, SMS Medical College and Attached Hospitals, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
09828373677 |
| Fax |
|
| Email |
maheshbagdi1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS medical college and attached hospitals, Jaipur, Rajasthan, pin code 302004 |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Attached Hospitals Jaipur Rajasthan |
| Address |
Department of Physical Medicine and Rehabilitation, SMS Medical College and Attached Hospitals, Jaipur, Rajasthan |
| Type of Sponsor |
Government 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 Mahesh Kumar Meena |
Sawai Man Singh Medical College, Jaipur, Rajasthan |
Department of Physical Medicine and Rehabilitation, SMS Medical College and Attached Hospitals, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
09828373677
maheshbagdi1970@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee, SMS medical college and attached hospital , Jaipur, Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G958||Other specified diseases of spinalcord, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) cases of acute traumatic cervical spinal cord injury of American spinal injury association grade A.
2)patients of age group 17 or more.
3)parents/guardians/patients willing to give valid and informed consent. |
|
| ExclusionCriteria |
| Details |
1)cases of thoracic, lumabr spinal cord injury.
2)any medical or surgical conditions which may interfere with study outcome. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)improvement in american spinal injury association grade (from grade A to B,C,D,E) 3 months post injury |
1)baseline (within 3 days of injury).
2) 3 months post injury.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)improvement in total motor scores.
2)improvement in total sensory scores.
3)improvement in total ASIA score .
|
from the date of trauma to 3 months post injury. |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
13/05/2024 |
| 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="10"
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
|
not published any study yet. this study is to determine the improvement in patients with acute cervical spinal cord injury patients on the basis of presence of early reflexes (patellar tendon reflex, bulbocavernosus/ ccr reflex, plantar reflex).
this study will also help in determining the independent positive predictors for prognosis of cervical spinal cord injury patients. |