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CTRI Number  CTRI/2025/04/084256 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 05/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Role of rehabilitation in functional improvement in different types of spinal cord injury patients  
Scientific Title of Study   Neurorehabilitation in traumatic vs non-traumatic spinal cord injury: A retrospective comparative analysis of outcomes from a newly established rehabilitation medicine department 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arvind Kumar Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 22, Department of Physical Medicine and Rehabilitation, AIIMS Raebareli, Dalmau Road, Munshiganj, Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arvind Kumar Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 22, Department of Physical Medicine and Rehabilitation, AIIMS Raebareli, Dalmau Road, Munshiganj, Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arvind Kumar Sharma 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 22, Department of Physical Medicine and Rehabilitation, AIIMS Raebareli, Dalmau Road, Munshiganj, Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405, India  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh  
Address  All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arvind Kumar Sharma   All India Institute of Medical Sciences, Raebareli   Room 22/28, Ground floor, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405 Rae Bareli UTTAR PRADESH
Rae Bareli
UTTAR PRADESH 
6388930133

arvindkgmu25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), AIIMS Raebareli, Uttar Pradesh, India   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G959||Disease of spinal cord, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients of age 18 years or older with a spinal cord injury admitted in the Physical Medicine and Rehabilitation Ward for in-patient neurorehabilitation
2. Patients with a minimum follow up duration of three months after first discharge
 
 
ExclusionCriteria 
Details  1. Patients unable to communicate or patients with altered mental status
2. Patients whose condition deteriorated during the study period needing further treatment.
3. Patients who were lost to follow-up prior to three months from date of first discharge  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Functional Independence Measure (FIM) score during admission, discharge, and follow up
2) Walking Index for Spinal Cord Injury (WISCI)
3) ASIA Impairment Scale (AIS) Improvement
 
1) At the time of admission
2) At the time of discharge
3) At the time of follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/05/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Understanding the rehabilitation needs and expected rehabilitation outcomes in different spinal cord injury (SCI) patients is essential in prognostic planning and guidance of the patient and care-giver from the outset. According to a World Health Organization (WHO) report, in the year 2021, there were around 15.4 million people living with SCI globally. Various differences exist in characteristics of patients who have sustained a SCI. Although SCI can be seen in both males and females, there is a clear difference, with the proportion of males among this patient population being as high as 81%.

The extent of impairment due to the SCI depends on the severity and location of injury. The causes of SCI can be broadly classified into traumatic and non-traumatic. The most common causes of traumatic SCI vary in different countries. Road traffic accidents (RTAs) account for the most cases of traumatic SCI in the developed nations. A study conducted to understand the demographic pattern of SCI patients in India reported RTAs as the most common cause (45.00%) followed by fall from height as the second leading cause (39.60%). However, other studies in developing nations in south-east Asia have reported falls from height as the leading cause. The reported incidence rate for traumatic SCI is 26.48 (95% CI, 24.15–28.93) per million people and that for non-traumatic SCI is 17.93 (95% CI, 13.30-23.26) per million people. The mean age for patients with an SCI due to traumatic causes was 41 years (95% CI: 28-57) whereas for non-traumatic SCIs it was reported to be 60 years (48-70). The older age of patients with non-traumatic SCIs makes their rehabilitation challenging due to the added age-related comorbidities.

Over the years, SCI due to non-traumatic causes has been on an incline. A study conducted among SCI patients (n=1080) in Italy reported 45% of the total cases having a non-traumatic origin of injury. Most common causes of non-traumatic SCI include spinal tumors, Pott’s spine, and transverse myelitis. The etiologies can be broadly classified as degenerative, inflammatory, neoplastic, and vascular. When comparing traumatic and non-traumatic SCI patients, a meta-analysis reported that most patients with traumatic SCI belonged to American Spinal Injury Impairment Scale (AIS) Grade A, where as those with non-traumatic SCI belonged to AIS grade D. The duration of stay in hospitals and the associated treatment cost also differ between the two groups, with traumatic SCIs incurring heavier expenditures on the patient. Thus, outcomes which can be expected between these two patient groups are different. Additionally, various medical complications could occur in SCI patients which affect their recovery, such as urinary tract infections (UTIs), pulmonary infections, pressure injuries, and neuropathic pain. They not only delay the recovery and increase the hospital stay, but they also worsen the outcomes of rehabilitation.

Very few studies exist in the Indian context which have reported on the demographics and outcomes of in-patient rehabilitation in SCI patients, with an emphasis on comparing the outcomes between traumatic and non-traumatic causes of SCI. Additionally, no studies have reported on the long-term implications of in-patient rehabilitation followed by community-based rehabilitation. Medical complications due to SCI and other pre-existing medical comorbidities influence the outcomes of rehabilitation. This study aims to better understand the demographics of SCI due to traumatic and non-traumatic causes, and compare the short and long-term outcomes of in-patient rehabilitation between the two groups.

Objectives

To assess the demographics of spinal cord injury patients admitted for rehabilitation in a tertiary health care institute

- To assess and compare the immediate and long-term neurological and functional outcomes in traumatic and non-traumatic SCI patients

- To assess and compare the rehabilitation needs of traumatic and non-traumatic SCI patients

Type of study: Our research approach involves a retrospective observational study, where we will gather and analyze quantitative and qualitative data to address our research objectives.

Data of all the SCI patients admitted in the PMR ward at the All-India Institute of Medical Sciences (AIIMS) Raebareli will be collected. Data will be extracted in a retrospective manner from the medical records of all these patients admitted in the previous two and a half years from March 2022 to August 2024. Patients who fulfill the inclusion and exclusion criteria will be included in the study for further data analysis.

All SCI patients admitted in PMR ward undergo a thorough clinical assessment and functional evaluation on admission, which is then repeated at discharge. A record of any medical complications and their management, at or during their admission period is maintained as a part of routine practice.

Patients are prescribed an individualized neurorehabilitation protocol which includes educating the patient and caregivers about the disease/ condition, prognosis and short- and long-term complications and their prevention (Postural care, Activity modification, and Dietary advice), the role of rehabilitation in PMR setting, identification of architectural barriers at home and appropriate management as indicated advised to the patient, prescription of various investigations, therapeutic exercises as indicated, prescription of orthotic devices as deemed necessary, and medications as needed.

The following data will be collected from the medical records of all SCI patients:

A)    Demographic and Socioeconomic Information

1)     Age

2)     Sex

3)     Education level

4)     Occupation

5)     Economic status.

B)    Information related to SCI:

1)     Time between injury and first admission for acute care

2)     Mode of transport from site of injury to place of primary care

3)     Time since injury

4)     Cause/ mechanism of injury

5)     Neurological level of injury

6)     Operative vs. conservative management

7)     American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade

8)     Length of hospital stay at first admission for rehabilitation

9)     Low extremity motor score (LEMS)

10)  Total motor score

11)  Total sensory score

12)  Means of bladder voiding and bowel management

13)  Pressure injuries

14)  Other medical complications of SCI

15)  Pre-existing comorbidities.

C)    Functional Outcome Measure:

1)     Functional Independence Measure (FIM) score during admission, discharge, and follow up

2)     Walking Index for Spinal Cord Injury (WISCI) [13] during admission, discharge, and follow up



 
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