FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093748 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Link between everyday activities and quality of life in people with middle spinal cord injury 
Scientific Title of Study   Correlation Between Activities of Daily Living and Quality of Life among Individuals with Thoracic 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  Ajay S 
Designation  postgraduate student  
Affiliation  Manipal college of health professions 
Address  Department of occupational therapy, MCHP, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  09791928343  
Fax    
Email  ajay.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Koushik Sau 
Designation  Assistant professor - Senior Scale 
Affiliation  MANIPAL COLLEGE OF HEALTH PROFESSIONAL 
Address  Department of occupational therapy, MCHP, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  7760064744  
Fax    
Email  koushik.sau@manipal.edu   
 
Details of Contact Person
Public Query  
Name  Koushik Sau 
Designation  Assistant professor - Senior Scale 
Affiliation  MANIPAL COLLEGE OF HEALTH PROFESSIONAL 
Address  Department of occupational therapy, MCHP, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  7760064744  
Fax    
Email  koushik.sau@manipal.edu   
 
Source of Monetary or Material Support  
Manipal college of health professions, Madhav nagar, Manipal-576104, Karnataka, India 
 
Primary Sponsor  
Name  Manipal college of health professions 
Address  Department of occupational therapy, Manipal College of Health Professions, Madhav nagar, Manipal-576104, Karnataka, India 
Type of Sponsor  Private 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 Ajay S  Spinal Injured Persons Association (SIPA)  D2, CLRI Quarters, 1, Sardar Patel Rd, Chennai, Tamil Nadu - 600020
Chennai
TAMIL NADU 		 9791928343

sipaspinal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S241||Other and unspecified injuries ofthoracic spinal cord,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1. English or Tamil-speaking individuals who had a spinal cord injury from the thoracic level for more than one year.
2. Individuals who have access to a smartphone with internet connectivity.
 
 
ExclusionCriteria 
Details  •Individuals with progressive or degenerative spinal conditions.
•Individuals with chronic diseases such as cancer.
•Individuals with co-existing psychiatric conditions or other neurological conditions that affect cognitive and communication abilities, hampering their understanding and comprehension, as self-reported or observed by the researcher.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary objective:
To identify the correlation between the activities of daily living and quality of life among individuals with thoracic spinal cord injury.


 		 1 day 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective:
1.To identify the performance of activities of daily living among individuals with thoracic spinal cord injury.
2.To identify the quality of life among individuals with thoracic spinal cord injury.
 		 1 day 
 
Target Sample Size   Total Sample Size="53"
Sample Size from India="53" 
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="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  

This cross-sectional study aims to explore the relationship between activities of daily living (ADL) and quality of life (QOL) among individuals with thoracic spinal cord injury (SCI). Unlike cervical or lumbar SCI, thoracic-level injuries present unique challenges, as individuals often retain upper limb function but experience significant limitations in lower limb mobility, which may impact daily functioning and overall life satisfaction.

A total of 53 participants will be recruited through the Spinal Injured Persons Association (SIPA), Chennai. Eligible participants will be Tamil or English-speaking individuals with thoracic SCI for more than one year, with access to smartphones and internet connectivity. Data will be collected using Microsoft Forms in both English and Tamil. The assessment will involve two standardised tools:

  • Spinal Cord Independence Measure (SCIM IV) – to evaluate ADL performance.
  • WHOQOL-BREF – to assess quality of life across physical, psychological, social, and environmental domains.

Descriptive and inferential statistical methods will be applied, including correlation analysis, t-tests, ANOVA, and non-parametric tests where applicable. Data analysis will be conducted using Jamovi software (version 2.3.28).

The study is expected to provide insights into how functional independence in daily living influences quality of life among individuals with thoracic SCI in the Indian cultural context. Findings may help guide rehabilitation strategies, improve client-centred care, and contribute to a better understanding of QOL determinants in this specific SCI population.

 

 
Close