| CTRI Number |
CTRI/2025/11/097164 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Hand Deformities Among Leprosy-Affected Adults in Delhi: A Cross-Sectional Study |
|
Scientific Title of Study
|
Prevalence of Hand Deformities Among Leprosy-Affected Adults in Delhi: A Cross-Sectional Study |
| Trial Acronym |
LEP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal Rawat |
| Designation |
Student |
| Affiliation |
Amity University Uttar Pradesh |
| Address |
Amity Institute of Health Allied Sciences(AIHAS)F1 Block, LGF, Sector-125,Noida-201303,India.
Sector-125, Amity University NOIDA(UP)-201301,INDIA
Amity Institute of Health Allied Sciences(AIHAS)F1 Block, LGF, Sector-125,Noida-201303,India.
Sector-125, Amity University NOIDA(UP)-201301,INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
09389723767 |
| Fax |
0120-2431870 |
| Email |
sheetalrawat14.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Jain |
| Designation |
Assistant Professor |
| Affiliation |
Amity University Uttar Pradesh |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999600611 |
| Fax |
0120-2431870 |
| Email |
ajain@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Jain |
| Designation |
Assistant Professor |
| Affiliation |
Amity University Uttar Pradesh |
| Address |
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Amity Institute of Health Allied Sciences (AIHAS) F 1 Block, LGF, Sector-125, Noida-201303, India. Sector-125, Amity University NOIDA (UP)-201301, INDIA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999600611 |
| Fax |
0120-2431870 |
| Email |
ajain@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Health Allied Sciences(AIHAS)F1 Block, LGF, Sector-125,Noida-201303,India. Sector-125, Amity University NOIDA(UP)-201301,INDIA |
|
|
Primary Sponsor
|
| Name |
Sheetal Rawat |
| Address |
Amity Institute of Health Allied Sciences(AIHAS)F1 Block, LGF, Sector-125,Noida-201303,India. Sector-125, Amity University NOIDA(UP)-201301,INDIA |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Manushri Parmar |
The Leprosy Mission, Shahdara Hospital |
Department of Physiotherapy, Rehabilitation Division, Ground Floor, The Leprosy Mission Hospital-Shahdara
Road No. 69, Tahirpur, Nand Nagri,
New Delhi - 110093
East
DELHI |
9548400083
0120-2431870
manushriparmar10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A30||Leprosy [Hansens disease], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Leprosy with a microbiological or clinical diagnosis
2. Willing to participate with informed consent
3. Age 18 or above
|
|
| ExclusionCriteria |
| Details |
1.Hand deformity due to other causes
2.Individuals who have undergone hand reconstructive surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of hand deformity among leprosy- affected adults in Delhi
|
At Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Association between functional limitations & these deformities.
2.Association between the deformities with duration of leprosy.
3. Relationship between sensory loss & occurrence of hand deformity .
|
At baseline |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
22/12/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 synopsis outlines a cross-sectional study titled "Prevalence of hand deformities among Leprosy-Affected adults in Delhi: A Cross-Sectional Study", The study aims to investigate the prevalence and distribution of hand deformities among leprosy patients in Delhi, a region with 1,188 total reported cases 2023 according to MoHFW, 2023. The research will also explore the association between these deformities, functional limitations, sensory loss and the duration of the disease. The methodology includes:
Study Design: A cross-sectional study with a sample size of 300 participants.
Population: Individuals aged 18 and older who have been clinically or microbiologically diagnosed with leprosy. Those with deformities from other causes or who have had hand reconstructive surgery will be excluded.
Outcome Measures: The Sensory testing using standardized tools and the Michigan Hand Outcomes Questionnaire (MHQ) for functional limitations. The WHO Disability Grading scale will be used to classify deformity severity.
Analysis: Data will be analyzed using Microsoft Excel and SPSS to determine the prevalence of deformities and the relationships between variables using descriptive statistics, the Chi-square test, and univariate logistic regression.
The study’s findings are expected to provide updated data to inform rehabilitation strategies and prevention programs for leprosy-related disabilities |