FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052350 [Registered on: 08/05/2023] Trial Registered Prospectively
Last Modified On: 04/05/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Functional impairments and quality of life in post burn adult patients 
Scientific Title of Study   Effect of burns on the functional impairments and quality of life in adult patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anu Arora 
Designation  Professor 
Affiliation  School of Physiotherapy, D.Y.Patil deemed to be University 
Address  School of Physiotherapy, D.Y.Patil deemed to be University Sector-5
Sector-5
Thane
MAHARASHTRA
400706
India 
Phone  08452842895  
Fax    
Email  anu.arora@dypatil.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anu Arora 
Designation  Professor 
Affiliation  School of Physiotherapy, D.Y.Patil deemed to be University 
Address  School of Physiotherapy, D.Y.Patil deemed to be University Sector-5
Sector-5
Thane
MAHARASHTRA
400706
India 
Phone  08452842895  
Fax    
Email  anu.arora@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Zoya Mohammed 
Designation  Physiotherapist 
Affiliation  School of Physiotherapy, D.Y.Patil deemed to be University 
Address  School of Physiotherapy, D.Y.Patil deemed to be University Sector-5

Mumbai
MAHARASHTRA
400706
India 
Phone  8433540116  
Fax    
Email  zoya.shaffi.16@gmail.com  
 
Source of Monetary or Material Support  
Self. No external Support 
 
Primary Sponsor  
Name  Zoya Mohammed 
Address  School of PT 
Type of Sponsor  Other [Individual] 
 
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 Shilpa Karnik  National Burns Centre  BURNS OPD Sector 13, Plot No. 1, Samarth Ramdas Swami Marg, Airoli, Navi Mumbai- 400078
Thane
MAHARASHTRA 
27796661

nbcairoli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECBH, DY Patil Medical College, Navi Mumbai.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age- 18 and above
2. Gender- male and female
3. Participants who are conscious and oriented.
4. At least 3 weeks post partial thickness burns.
5. At least 6 weeks post full thickness/surgically managed burn injury.
6. Give written informed consent to the study.
 
 
ExclusionCriteria 
Details  Unstable vitals.
Participants who sustained fracture during burns.
Participants with neurological involvement.
Participants with cognitive impairment.
Participants with a clinically diagnosed psychiatric condition.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome measure-
1.Pain (NRS)
2.Total body surface area and depth of burn (Lund and Browder chart.)
3. Upper limb functional impairment (QuickDASH)
4. Lower limb functional impairment [Lower Limb Functional Index-10 (LLFI-10)]
5. Quality of life [Burn-Specific Health Scale- revised brief and adapted (BSHS-RBA)]
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
statistically significant determinants of disability in burns cases  Same day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/05/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be done after completion 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included anu.arora@dypatil.edu).

  6. For how long will this data be available start date provided 16-03-2023 and end date provided 16-05-2023?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Burns commonly known as an injury to the skin caused by numerous agents such as heat, chemicals, electricity, and radiation is a debilitating concern. According to World Health Organization’s fact sheet of 2018 the global estimation of deaths due to burn injury is 1,80,000 per year. In India, 7 million people are the victim of burn injuries with over 10,00,000 people are casualty of moderate or severe burn injury every year1 and 2.4 lakh people suffering from a disability2 and burns is one of the leading cause of disability-adjusted life years (DALYs).1, 3 The incidence of burns in India hikes in Diwali festival with more than 23,000 fire-related deaths were estimated in India in the year 2019, which accounts for 20% of the global mortality burden. Also, 1.5 million DALYs were attributed to burns3. Burn patients do not exhibit homogeneity, the functional outcome is dependent on various factors such as age, mechanism of injury, total body surface area, depth as well as the site of the burn. Burns not only influences a person’s physical, psychological, and social functioning but also it often results in significant morbidity, impairment in emotional well-being, and negative effects on the appearance in turn affecting their ability to return to work.

 

Brief summary- It is important to understand the repercussions of burns beyond their quantification in terms of total body surface area and its depth because there are many confounding factors such as age, gender and personal factors could be varied and may affect the patient’s condition.  Hence, there is a need to see an association between the quantification of burns with functional impairments and quality of life.

 
Close