CTRI Number |
CTRI/2023/08/056650 [Registered on: 18/08/2023] Trial Registered Prospectively |
Last Modified On: |
10/08/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
in healthy and obese patients with knee OA, a relationship study between core muscle strength, rectus femoris flexibility and quadriceps strength |
Scientific Title of Study
|
A correlation study of core muscles strength with rectus femoris flexibility and quadriceps strength in normal and obese patients with 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 |
Manalisa kalita |
Designation |
MPT student |
Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation |
Address |
Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana Ambala,Hryana
Ambala HARYANA 133207 India |
Phone |
8753931655 |
Fax |
|
Email |
manalisakalita5147@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sunita Sharma |
Designation |
Associate Professor |
Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation |
Address |
Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana-Ambala,Hryana
Ambala HARYANA 133207 India |
Phone |
9467633734 |
Fax |
|
Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person Public Query
|
Name |
Sunita Sharma |
Designation |
Associate Professor |
Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation |
Address |
Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana-Ambala,Hryana
Ambala HARYANA 133207 India |
Phone |
9467633734 |
Fax |
|
Email |
drsunita.sharma@mmumullana.org |
|
Source of Monetary or Material Support
|
Orthopaedic Physiotherapy research lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be university), Mullana, Ambala, Haryana |
|
Primary Sponsor
|
Name |
Manalisa kalita |
Address |
Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana-Ambala,Haryana |
Type of Sponsor |
Other [self] |
|
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 |
Manalisa Kalita |
Maharishi Markandeshwar superspeciality hospital |
Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana-Ambala, Haryana Ambala HARYANA |
08753931655
manalisakalita5147@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethical committee M.M Institute of medical science and research, Mullana(Ambala) |
Approved |
|
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
|
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients who have taken physiotherapy treatment and no physiotherapy treatment both will be included.
pain should be at least 30mm on 100mm VAS.
knee pain in at least one limb should be provoked by running, walking, hoping, squatting.
Knee OA grade 2 and grade 3 |
|
ExclusionCriteria |
Details |
Lower extremity injuries or fractures
Complain of LBP, Hip, ankle, or foot pain
History of surgery of lower extremity
unable to ambulate independently with or without an assistive device
pregnant subject and those who underwent recent pregnancy
patient with a metabolic disorder like diabetes mellitus |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
•Core muscle strength: Pressure Biofeedback Unit
•Quadriceps flexibility: Ely’s Test
|
baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
•Quadriceps strength: Isokinetic Dynamometer
•Visual Analogue scale (VAS)
|
baseline |
|
Target Sample Size
|
Total Sample Size="77" Sample Size from India="77"
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)
|
25/08/2023 |
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
|
Background: Most
people with increasing age are suffering from different kinds of joint
diseases, among them, Osteoarthritis (OA) is the most common one, which is a
clinical condition of joint pain and dysfunction brought on by joint
deterioration. The knee is the most prevalent location for OA, even though various
lower extremity joints, including the ankle and hip, may be affected. OA raises
the risk of morbidity and death, causes pain and disability, and lowers the
quality of life. Increased age and Body Mass Index (BMI) is the most common
risk factor for developing knee Osteoarthritis (knee OA), and also females are
more prone to develop knee OA. It has been proven that exercising regularly can
lessen the discomfort caused by knee OA.
Aim: The aim of the study is
to find the relation between core muscle strength with rectus femoris
flexibility and quadriceps strength in obese and non-obese patients with knee
OA.
Methodology: Obese
and non-obese participants aged 40 to 70 will be recruited according to knee OA
grade 2 and 3. The demographic data of the participants will be allocated to
the obese and non-obese groups. Then the participants will be assessed for core
muscle strength, rectus femoris flexibility, and quadriceps strength and the data
obtained will be compared for both groups. Outcome measures like Pressure Biofeedback
Unit, Isokinetic Dynamometer, Ely’s Test, and Visual Analogue Scale (VAS) will
be used for the assessment.
Data analysis: Kolmogorov-Smirnov
test will be applied to check normality. If the data is found to be normally
distributed, the independent t-test will be used between groups. If the data is
not found to be normally distributed, then the Mann-Whitney U test will be used.
Keywords: Core muscle strength,
knee osteoarthritis, Obese and non-obese, Rectus femoris flexibility, Quadriceps
strength |