| CTRI Number |
CTRI/2023/09/058037 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The relation between lateral muscles of the hip and balance in older individuals with knee joint arthritis |
|
Scientific Title of Study
|
Relationship between hip abductor muscle strength and balance in elderly individuals with unilateral 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 |
Reshma Pillai |
| Designation |
Master of Physiotherapy(MPT) student |
| Affiliation |
Manipal College of Health Professions , Manipal Hospital, Bangalore |
| Address |
Upper Basement, # 98, HAL, Old Airport Road, Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital , Bangalore -560017
Bangalore
KARNATAKA
560017
India |
| Phone |
8530416567 |
| Fax |
|
| Email |
reshma.mhsblr2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karvannan H |
| Designation |
Associate Professor of Physiotherapy |
| Affiliation |
Manipal College of Health Professions, Manipal Hospitals Bangalore , Manipal Hospital, Bangalore |
| Address |
Upper Basement, # 98, HAL, Old Airport Road, Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital , Bangalore -560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karvannan H |
| Designation |
Associate Professor of Physiotherapy |
| Affiliation |
Manipal College of Health Professions, Manipal Hospitals Bangalore , Manipal Hospital, Bangalore |
| Address |
Upper Basement, # 98, HAL, Old Airport Road, Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital , Bangalore -560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Upper Basement, # 98, HAL, Old Airport Road, Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital , Bangalore -560017 |
|
|
Primary Sponsor
|
| Name |
Manipal College Of Health Professions, Manipal Hospital Bangalore |
| Address |
Upper Basement, # 98, HAL, Old Airport Road, Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital , Bangalore -560017 |
| 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 |
| Reshma Pillai |
Manipal Hospital |
Orthopedic OPD, Manipal Hospital, Old Airport road, HAL, Bangalore
Bangalore
KARNATAKA |
8530416567
reshma.mhsblr2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age 60-80 years
Both gender
Individuals with primary unilateral knee osteoarthritis |
|
| ExclusionCriteria |
| Details |
Rheumatoid Arthritis
Parkinsonism
Vestibular problems
Stroke
Diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hip abductor muscle strength and balance with the help of hand- held dynamometer and Biodex Balance system SD |
Immediate observation at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the involvement of balance in participants with knee osteoarthritis and normal individuals |
Immediate observation at baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2023 |
| Date of Study Completion (India) |
19/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis is a degenerative condition of the joints in which there is wearing of the articular cartilage that causes friction between the bones and leads to pain and stiffness. This is an observational study that focuses on assessing the relationship between hip abductor muscle strength and balance in individuals with unilateral knee osteoarthritis. To assess whether there is the involvement of reduced muscle strength that causes loss of balance, the participants will be recruited from Manipal Hospital, Bangalore with a sample size of 100. Balance is to be assessed with the help of Biodex Balance System SD and hip abductor muscle strength is to be assessed using the hand-held dynamometer. |