| CTRI Number |
CTRI/2024/03/064240 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Physical performance and balance in knee osteoarthiritis |
|
Scientific Title of Study
|
Relationship with balance and physical performance knee osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya S |
| Designation |
MPT Orthopaedics And Traumatology |
| Affiliation |
Sri Ramachandra institute of Higher Education And Research |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
NO.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
8825652747 |
| Fax |
|
| Email |
t0222013@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Angeline R |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra institute of Higher Education And Research |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
NO.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9943529400 |
| Fax |
|
| Email |
angelinejobin75@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Angeline R |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra institute of Higher Education And Research |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
NO.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9943529400 |
| Fax |
|
| Email |
angelinejobin75@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Balance and postural stability system |
|
|
Primary Sponsor
|
| Name |
Aishwarya S |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
NO.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Aishwarya S |
Sri Ramachandra Institute of Higher education and Research |
Sri Ramachandra Institute Of Higher Education And Research, Sri Ramachandra Nagar,Porur,Chennai,Tamilnadu-600116
Chennai
TAMIL NADU |
8825652747
t0222013@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE FOR STUDENT PROJECTS, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,[DEEMED TO BE UNIVERSITY],PORUR,CHENNAI-600116,TAMILNADU,INDIA. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
knee OA with radiological verified unilateral pain
knee OA grade less than 3 based on kellgren- lawrence grading
sufficient cognition and communication skills to understand nature of study |
|
| ExclusionCriteria |
| Details |
acute and chronic cardiac and pulmonary problem
acute and chronic systemic condition
recent musculoskeletal lower extremity injuries
joint infection
rheumatoid arthritis
any orthopaedic surgeries |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance And Postural Stability System |
1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TUG test |
1 |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
03/07/2024 |
| 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="3"
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
|
•Knee osteoarthritis (KOA) is one of the chronic disease affecting elderly person. •Patients with knee OA typically have impairment of proprioception within the joint or weakness in the quadriceps muscles than normal people. These impairments associated with the disease may explain the poor balance. •Pain and restricted range of motion of leg caused by knee OA adversely affect the balance and thereby physical performance ,function and QOL of elderly people. •Individuals with knee OA suffer progressive loss of function, displaying increasing dependency in walking, stair climbing and other lower extremity tasks . Balance is an integral component of these and many other activities of daily living. •Understanding the impact of balance may allow possible mechanisms of disability in KOA patients and this needs to be elucidated, and this may permit more effective management of patients with the disease. •Limited research has evaluated the influence of balance on performance . · Subjects
with radio graphically conformed , symptomatic OA knee would be recruited for
study. Subjects
will complete a baseline interview with a investigator that would include
demographic survey (age, gender, BMI, patient reported outcome measures-KOOS
scale).
Physical
performance test would includes TUG test,30s chair stand test , stair climb
test , balance list (static – balance and postural stability system and single
leg test and dynamic –step test). check whether balance will affect the physical performance of the patient who have knee osteoarthritis |