| CTRI Number |
CTRI/2024/04/066228 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on different factors that could affect a person in daily activities with inability to either move objects or move themselves due to their disability. |
|
Scientific Title of Study
|
Predictors of functional limitation in persons with Locomotor Disability. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varun Pratap Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Physical Medicine and Rehabilitation, Vardhman Mahavir Medical College and Safdarjung hospital
South
DELHI
110037
India |
| Phone |
9313893596 |
| Fax |
|
| Email |
varunpratapsingh74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Jain |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Room no. 33,Department of Physical Medicine and Rehabilitation, Vardhman Mahavir Medical College and Safdarjung hospital
South
DELHI
110029
India |
| Phone |
9999143589 |
| Fax |
|
| Email |
shweta_10775@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Pratap Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Physical Medicine and Rehabilitation, Vardhman Mahavir Medical College and Safdarjung hospital
South
DELHI
110029
India |
| Phone |
9313893596 |
| Fax |
|
| Email |
varunpratapsingh74@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physical Medicine and Rehabilitation, Vardhan Mahavir Medical College and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Room 33, Department of Physical Medicine and Rehabilitation, VMMC AND SJH HOSPITAL |
| Type of Sponsor |
Government medical college |
|
|
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 Varun Pratap Singh |
Vardhman Mahavir Medical College and Safdarjung hospital |
Room number:33, Department of Physical Medicine and Rehabilitation
South
DELHI |
9313893596
varunpratapsingh74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE,VMMC AND SAFDARJUNG HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F||Physical Rehabilitation and Diagnostic Audiology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged between 18 and 60 years having a diagnosis of permanent locomotor disability living in the community at least for 6 months before participation and can obey simple commands |
|
| ExclusionCriteria |
| Details |
1) Individual with cognitive and perceptual problems
2) Dementia or problems with memory
3) Psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out -
1) correlation between functional limitation and demographic factors.
2) functional limitation and clinical parameters
3) functional limitation and environmental barriers |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the impact of type of locomotor disability (as defined in gazette according to Rights of persons with Disabilities Act) on Activities of Daily Living and Instrumental activities of Daily Living |
18 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
05/05/2024 |
| 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="1"
Months="6"
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
|
Aim of the study is to identify predictors of functional limitation in persons with locomotor disability. The primary objective is to find out correlation between functional limitation and other factors. The secondary objective is to find out the impact of type of locomotor disability on Activities of Daily Living and Instrumental Activities of Daily Living limitation. |