| 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
|
|
|
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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included anu.arora@dypatil.edu).
- 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.
- 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. |