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CTRI Number  CTRI/2024/08/071989 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   knowledge and perception of physiotherapy services in caregivers of patients with spinal cord injury  
Scientific Title of Study   Knowledge, Attitude and Perception of Physiotherapy Service Among Care Givers in Spinal Cord Injury Patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tibin Thomas  
Designation  postgraduate student 
Affiliation  NITTE Insititute of Physiotherapy, NITTE Deemed to be university  
Address  Department of Physiotherapy, Room No 20,second base division, Nitte institute of physiotherapy NITTE(Deemed to be university) Derlakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  08547586243  
Fax    
Email  tibin2409@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Jayesh Chandran 
Designation  Assistant Professor 
Affiliation  Nitte institute of physiotherapy NITTE(Deemed to be university) 
Address  Department of Physiotherapy, Room No 20,second base division, Nitte institute of physiotherapy NITTE(Deemed to be university) Derlakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9383443710  
Fax    
Email  jayesh.nairpt@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Mr Jayesh Chandran 
Designation  Assistant Professor 
Affiliation  NITTE Institute of Physiotherapy, NITTE (Deemed to be university) 
Address  Department of Physiotherapy, Room No 20,second base division, Nitte institute of physiotherapy NITTE(Deemed to be university) Derlakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9383443710  
Fax    
Email  jayesh.nairpt@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of physiotherapy, Room 20, second base division, NITTE institute of physiotherapy, NITTE (Deemed to be university) Derlakatte, Mangaluru 575018, Karnataka, India  
 
Primary Sponsor  
Name  NITTE Institute of physiotherapy NITTE Deemed to be university 
Address  Department of Physiotherapy ROOM No, 20 Second Base Division, Nitte Institute of Physiotherapy. NITTE (Deemed to be University ) Derlakatte, Mangaluru -575018 Karnataka India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tibin Thomas  Justice K.S Hegde Charitable Hospital  Department No 12, Department of Neurology and Neurosurgery, Department of Orthopedics, room number 9, medical science complex, Deralakatte, Mangaluru Dakshnia Kannada Karnataka
Dakshina Kannada
KARNATAKA 		 08547586243

tibin2409@gmail.com 
Tibin Thomas  Seva Bharathi  Sevanikethana Kanyadi- II, Dharmasthala Post and village. D.K, Karnataka, India 574216
Dakshina Kannada
KARNATAKA 		 08547586243

tibin2409@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional ethics committee of Nitte Institute of Physiotherapy  Approved 
Institutional ethics committee of Nitte Institute of Physiotherapy  Approved 
Institutional ethics committee of Nitte Institute of Physiotherapy  Approved 
Institutional ethics committee of Nitte Institute of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  caregivers of patient with spinal cord injury 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Caregivers of paraplegic or tetraplegic traumatic spinal cord injury patients.
2.Able to understand and comprehend the questionnaire.
3.Caregivers who are willing to participate in the study.
4.Caregivers in the rural area
 
 
ExclusionCriteria 
Details  1.Caregivers of non-traumatic spinal cord injury
2.caregivers who are medical professionals or students 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
selfmade questionnaire  At Baseline (At the begining of the study)  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/08/2024 
Date of Study Completion (India) 17/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   Traumatic spinal cord injury (SCI) is a neurological damage to the spinal cord caused by various factors such as falls, motorbike accidents, auto accidents, sports, water-related injuries, gunshots, stabbing, disease, infection, and congenital defects. Around 20,000 new Traumatic SCI cases are reported annually. SCI presents significant health, economic, and social consequences, with a two to five times higher risk of premature death. Caregivers play a crucial role in reducing the likelihood of recurrent issues and maintaining physical health. Informal caretakers, who help patients with SCI, can provide a familiar environment and lower healthcare expenses. However, long-term care providers often have a negative attitude towards the patient’s handicap, negatively impacting caregivers’ attitudes and quality of care. Caregivers of SCI patients may experience physical discomfort, melancholy, anxiety, and grief, as well as psychosocial problems. Physiotherapists play a vital role in promoting physical activity and self-determination for long-term health.so it is important to assess the knowledge, attitude, and perception of physiotherapy treatment in caregivers of SCI patients by using a self-made questionnaire. 
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