| CTRI Number |
CTRI/2025/08/093578 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
From Hospital to Community, How Rehabilitation Supports Participation After Spinal Cord Injury |
|
Scientific Title of Study
|
Effect of Rehabilitation on activity and participation levels in individuals with spinal cord injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Jain |
| Designation |
Professor |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
| Address |
Room no 33, Department of PMR, VMMC and SJH, Delhi.
South
DELHI
110029
India |
| Phone |
9999143589 |
| Fax |
|
| Email |
shweta_10775@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Jain |
| Designation |
Professor |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
| Address |
Room no 33, Department of PMR, VMMC and SJH, Delhi
DELHI
110029
India |
| Phone |
9999143589 |
| Fax |
|
| Email |
shweta_10775@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
A Suryaveda |
| Designation |
PG student |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
| Address |
Resident doctor hostel, Safdarjung Campus, Ansari Nagar West, New Delhi, Delhi, India 110029
South
DELHI
110029
India |
| Phone |
8171053346 |
| Fax |
|
| Email |
suryaaddu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
A SURYAVEDA |
| Address |
Resident doctor hostel, Safdarjung Campus, Ansari Nagar West, New Delhi, Delhi, India 110029 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 A SURYAVEDA |
SAFDARJUNG HOSPITAL |
Department of PMR, Ward 33, 3rd floor, Near Blood bank
South
DELHI |
8171053346
SURYAADDU@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe, Vardhman Mahavir Medical college and Safdarjung hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S141||Other and unspecified injuries ofcervical spinal cord, (2) ICD-10 Condition: S241||Other and unspecified injuries ofthoracic spinal cord, (3) ICD-10 Condition: S341||Other and unspecified injury of lumbar and sacral spinal cord, (4) ICD-10 Condition: G822||Paraplegia, (5) ICD-10 Condition: G825||Quadriplegia, (6) ICD-10 Condition: G834||Cauda equina syndrome, (7) ICD-10 Condition: G833||Monoplegia, unspecified, (8) ICD-10 Condition: G839||Paralytic syndrome, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 18 and 60 years diagnosed of Spinal cord injury within 3 months of injury duration who can obey simple commands. |
|
| ExclusionCriteria |
| Details |
Individual with cognitive and perceptual problems
Dementia or problems with memory and Psychiatric disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and observe the change in activity and participation levels in patients before and after rehabilitation in spinal cord injury using ICF core set.
|
At baseline, 2 months and 4 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/09/2025 |
| 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="6"
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
|
This is a prospective observational longitudinal study conducted at the Department of Physical Medicine and Rehabilitation, Safdarjung Hospital, New Delhi, involving 30 individuals with spinal cord injury (both traumatic and non-traumatic). The study aims to evaluate changes in functioning using the Activity and Participation components of the Brief ICF Core Set. Assessments are carried out at three time points: at admission (pre-rehabilitation), 2 months after completion of inpatient rehabilitation, and 2 months after discharge. In addition to functional outcomes, the study also analyzes the impact of demographic profile, severity of injury, environmental factors, and personal factors, including socioeconomic status, on rehabilitation outcomes. The findings are expected to provide insight into the role of contextual and individual factors in the functional recovery of SCI patients. |