Role of rehabilitation in functional improvement in different types of spinal cord injury patients

Not yet recruiting

• Conditions: Disease of spinal cord, unspecified,

• Registration Number: CTRI/2025/04/084256
• Lead Sponsor: All India Institute of Medical Sciences, Raebareli, Uttar Pradesh

Brief Summary

Understanding the rehabilitation needs and expected rehabilitationoutcomes in different spinal cord injury (SCI) patients is essential inprognostic planning and guidance of the patient and care-giver from the outset.According to a World Health Organization (WHO) report, in the year 2021, therewere around 15.4 million people living with SCI globally. Variousdifferences 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 andlocation of injury. The causes of SCI can be broadly classified into traumaticand non-traumatic. The most common causes of traumatic SCI vary in differentcountries. Road traffic accidents (RTAs) account for the most cases oftraumatic SCI in the developed nations. A study conducted to understand thedemographic pattern of SCI patients in India reported RTAs as the most commoncause (45.00%) followed by fall from height as the second leading cause(39.60%). However, other studies in developing nations in south-east Asiahave reported falls from height as the leading cause. The reportedincidence rate for traumatic SCI is 26.48 (95% CI, 24.15–28.93) per millionpeople and that for non-traumatic SCI is 17.93 (95% CI, 13.30-23.26) permillion people. The mean age for patients with an SCI due to traumaticcauses was 41 years (95% CI: 28-57) whereas for non-traumatic SCIs it wasreported to be 60 years (48-70). The older age of patients withnon-traumatic SCIs makes their rehabilitation challenging due to the addedage-related comorbidities.

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

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

**Objectives**

**-**To assess the demographics ofspinal cord injury patients admitted for rehabilitation in a tertiary healthcare institute

- To assess and compare theimmediate and long-term neurological and functional outcomes in traumatic andnon-traumatic SCI patients

- To assess and compare therehabilitation 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 addressour research objectives.

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

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

Patients are prescribed anindividualized neurorehabilitation protocol which includes educating the patient and caregivers about the disease/ condition,prognosis and short- and long-term complications and their prevention (Posturalcare, Activity modification, and Dietary advice), the role of rehabilitation inPMR setting, identification of architectural barriers at home and appropriatemanagement as indicated advised to the patient, prescription of variousinvestigations, therapeutic exercises as indicated, prescription of orthoticdevices as deemed necessary, and medications as needed.

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

**A)****Demographic andSocioeconomic Information**

1)    Age

2)    Sex

3)    Education level

4)    Occupation

5)    Economic status.

**B)****Information related to SCI**:

1)    Time between injury and firstadmission for acute care

2)    Mode of transport from site ofinjury 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 InjuryAssociation (ASIA) Impairment Scale (AIS) grade

8)    Length of hospital stay atfirst admission for rehabilitation

9)    Low extremity motor score(LEMS)

10) Total motor score

11) Total sensory score

12) Means of bladder voiding andbowel management

13) Pressure injuries

14) Other medical complications ofSCI

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 CordInjury (WISCI) [13] during admission, discharge, and follow up

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-05
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients unable to communicate or patients with altered mental status 2.
• Patients whose condition deteriorated during the study period needing further treatment.
• Patients who were lost to follow-up prior to three months from date of first discharge.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Functional Independence Measure (FIM) score during admission, discharge, and follow up	1) At the time of admission | 2) At the time of discharge | 3) At the time of follow-up
2) Walking Index for Spinal Cord Injury (WISCI)	1) At the time of admission | 2) At the time of discharge | 3) At the time of follow-up
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

Trial Locations

Locations (1)

All India Institute of Medical Sciences, Raebareli; 🇮🇳 Bareli, UTTAR PRADESH, India

All India Institute of Medical Sciences, Raebareli

🇮🇳Bareli, UTTAR PRADESH, India

Dr Arvind Kumar Sharma

Principal investigator

6388930133

arvindkgmu25@gmail.com