| CTRI Number |
CTRI/2024/03/064282 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the limitation of activities and restrictions on participation among elderly individuals with symptomatic knee osteoarthritis using the International Classification of Functioning, Disability, and Health: A cross-sectional study. |
|
Scientific Title of Study
|
ASSESSMENT OF ACTIVITY LIMITATION AND PARTICIPATION RESTRICTION IN THE ELDERLY POPULATION WITH SYMPTOMATIC KNEE OSTEOARTHRITIS USING THE INTERNATIONAL CLASSIFICATION OF FUNCTIONING, DISABILITY AND HEALTH: A CROSS SECTIONAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SEEMA SIDDIQUA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
COLLEGE OF PHYSIOTHERAPY , DAYANANDA SAGAR UNIVERSITY |
| Address |
Department of Community Based Rehabilittaion College of Physiotherapy,DSU, Shavige malleshwara hills, kumarswamy layout Bangalore Karnataka -560078
Department of Community Based Rehabilittaion College of Physiotherapy,DSU, Shavige malleshwara hills, kumarswamy layout Bangalore Karnataka -560078
Bangalore
KARNATAKA
560078
India |
| Phone |
7022827740 |
| Fax |
|
| Email |
seemasiddiqua06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srihari Sharma |
| Designation |
Assocaite Professor |
| Affiliation |
College of Phsyiotherapy,DAYANANDA SAGAR UNIVERSITY |
| Address |
Department of CardioRespiratory Physiotehrapy,College of Physiotherapy,DSU, Shavige malleshwara hills, kumarswamy layout Bangalore Karnataka -560078
Department of CardioRespiratory Physiotehrapy,College of Physiotherapy,DSU, Shavige malleshwara hills, kumarswamy layout Bangalore Karnataka -560078
Bangalore
KARNATAKA
560078
India |
| Phone |
9886040520 |
| Fax |
|
| Email |
srihari-physio@dsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri |
| Designation |
Assitant Professor |
| Affiliation |
College of Phsyiotherapy,DAYANANDA SAGAR UNIVERSITY |
| Address |
Deapartment of Community Based Rehabilitation College of Physiotherapy,DSU, Shavige malleshwara hills, kumarswamy layout Bangalore Karnataka -560078
Deapartment of Community Based Rehabilitation College of Physiotherapy,DSU, Shavige malleshwara hills, kumarswamy layout Bangalore Karnataka -560078
Bangalore
KARNATAKA
560078
India |
| Phone |
9108169985 |
| Fax |
|
| Email |
gayathri-physio@dsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Urban Health Training Center Kankapura, Department of community Medicine CDSIMER 562117 |
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
Department of Community Based Rehabilittaion College of Physiotherapy,DSU, Shavige malleshwara hills, kumarswamy layout Bangalore Karnataka -560078 |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| DrGayatri Poojary |
kanakapura Taluk |
Harohalli, Kanakapura
Bangalore Rural
KARNATAKA |
8618664334
seemasiddiqua06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dayananda Sagar Instiutional Ethics Committee |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with knee pain as a primary complain and experience difficulty in performing ADLs.
a. Pain in unilateral/bilateral knee
b. According to American College of Rheumatology criteria for knee OA Knee (clinical) Osteoarthritis
if 1, 2, 3, 4 or 1, 2, 5 or 1, 4, 5 are present:
1. Knee pain for most days of previous month
2. Crepitus on active joint motion
3. Morning stiffness lasting 30 min or less
4. Age 38 years or older
5. Bony enlargement of the knee on examination
6. Subjects willing to participate |
|
| ExclusionCriteria |
| Details |
a.Individuals with cognitive impairments (that hinder their ability to provide reliable information).
b.Individuals with severe comorbidities or medical conditions that significantly impact their mobility and overall well-being, unrelated to knee OA.
c. Individuals who have undergone any lower limb surgery within the past six months.
d. History of systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.ICF proforma(activity Limitation and Participation restriction) Domain
|
0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.WHOQOL BREF questionnaire |
0 |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
30/03/2024 |
| 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="0"
Months="2"
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
|
need of the study: As there is a paucity of literature describing the specific activity limitation and participation restrictions experienced by the elderly population in with symptomatic knee Osteoarthritis in rural population. our study seeks to identify the specific limitation they face in their daily lives, leisure activities, and overall well-being, using ICF frame work and WHOQOL BREF questionnaire. Enable more focused treatments and to assist in developing strategies to overcome these challenges. methdology: Subjects will be selected based on the inclusion and exclusion criteria. Demographic data such as age, height, weight, BMI, occupation, pain in unilateral /bilateral knee, be collected in the screening form. Participants who met the inclusion criteria will be included in the study.the purpose and procedure of study will be explained to the subject in their vernacular language and informed consent will be taken. Using ICF frame work subject will be screened for the activity limitation and quality of life will screened using WHOQOL Data collected post intervention will be documented and analysed. |