| CTRI Number |
CTRI/2024/08/072900 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of quality of life of persons with difficulty in walking or standing in North East India |
|
Scientific Title of Study
|
Assessment of quality of life of persons with locomotor disability in North East India |
| 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 Satyaranjan Sethi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
Department of Physical Medicine and Rehabilitation AIIMS Guwahati
room no 1075
Kamrup
ASSAM
781101
India |
| Phone |
8440963963 |
| Fax |
|
| Email |
satyaranjansethi@aiimsguwahati.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyaranjan Sethi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
Department of Physical Medicine and Rehabilitation AIIMS Guwahati
room no. 1075
ASSAM
781101
India |
| Phone |
8440963963 |
| Fax |
|
| Email |
satyaranjansethi@aiimsguwahati.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ebenezer kyndiah |
| Designation |
Senior Resident Doctor |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
Department of Physical Medicine and Rehabilitation AIIMS Guwahati
Room no 1073
Kamrup
ASSAM
781101
India |
| Phone |
9436588334 |
| Fax |
|
| Email |
ebenezerkyndiah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physical Medicine and Rehabilitation, AIIMS Guwahati India
Pin 780101 |
|
|
Primary Sponsor
|
| Name |
Department of Physical Medicine and Rehabilitation |
| Address |
OPD Building AIIMS Guwahati India
pin 780101 |
| 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 EBENEZER KYNDIAH |
All India Institute of Medical Sciences Guwahati |
Department of Physical Medicine and Rehabilitation OPD Building Room No. 1072,1073,1075,1076
Kamrup
ASSAM |
9436588334
ebenezerkyndiah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Guwahati Ethic committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient with single or multiple locomotor disability.
All age and gender
Permanent locomotor disability
|
|
| ExclusionCriteria |
| Details |
Disability before 2 years
Severe co-morbidities including cardiovascular diseases, mental disorders, cancer, respiratory disease etc.
All disorder which are progressive in nature.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health related QoL score, Functional score |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(a)SF-36- scoreTo study Quality of life.
(b)Barthel Index score for function
|
baseline |
|
|
Target Sample Size
|
Total Sample Size="123"
Sample Size from India="123"
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)
|
01/09/2024 |
| 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 Applicable |
| 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
|
The primary objective of the study is to assess
the correlation between locomotor disabilities and the quality of life in person with permanent locomotor disability. The study also is also aimed to study the correlation of:
1. Quality of life with types of locomotor disability.
2. Quality of life with age of onset of locomotor disability.
3. Quality of life
with percentage of permanent physical
impairment. 4. Associated factors
affecting quality of life in locomotor disability |