CTRI Number |
CTRI/2022/09/045586 [Registered on: 16/09/2022] Trial Registered Prospectively |
Last Modified On: |
13/09/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
Activation of quadriceps during straight leg raise in different hip positions among patients with knee disease |
Scientific Title of Study
|
RECRUITMENT PATTERN OF QUADRICEPS DURING ACTIVE straight leg raise(SLR) IN VARYING HIP POSITIONS AMONG PATIENTS WITH DEGENERATIVE JOINT DISEASE OF KNEE |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Bhooma Praneetha |
Designation |
Student |
Affiliation |
Sri ramachandra institute of higher education and research |
Address |
Sri ramachandra institute of higher education and research,
faculty of physiotherapy
Porur, chennai
Sri ramachandra institute of higher education and research,
faculty of physiotherapy
Porur, chennai Chennai TAMIL NADU 600116 India |
Phone |
7989747544 |
Fax |
|
Email |
t0220003@sriramachandra.edu.in |
|
Details of Contact Person Scientific Query
|
Name |
ADGopalswami |
Designation |
Associate professor |
Affiliation |
Sri ramachandra institute of higher education |
Address |
Sri ramachandra institute of higher education and research,
faculty of physiotherapy
Porur, chennai Sri ramachandra institute of higher education and research,
faculty of physiotherapy
Porur, chennai Chennai TAMIL NADU 600116 India |
Phone |
9884500566 |
Fax |
|
Email |
gopalswami@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
Name |
ADGopalswami |
Designation |
Associate professor |
Affiliation |
Sri ramachandra institute of higher education |
Address |
Sri ramachandra institute of higher education and research,
faculty of physiotherapy,
Porur, chennai Sri ramachandra institute of higher education and research,
faculty of physiotherapy,
Porur, chennai Chennai TAMIL NADU 600116 India |
Phone |
9884500566 |
Fax |
|
Email |
gopalswami@sriramachandra.edu.in |
|
Source of Monetary or Material Support
|
Sri ramachandra institute of higher education and research |
|
Primary Sponsor
|
Name |
Sri ramachandra institude of higher education and research |
Address |
Sri ramachandra institute of higher education and research, porur, chennai |
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 |
Bhooma Praneetha |
Sri ramachandra institute of higher education and research |
Sri ramachandra hospital,
Faculty of physiotherapy,
G block, OPD Chennai TAMIL NADU |
7989747544
t0220003@sriramachandra.edu.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
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
|
Type |
Name |
Details |
Intervention |
external rotation group |
Group 3 : EXternal rotation of SLR
Quadriceps strengthening exercises
intervention given for 2 weeks
5 Exercises
Each exercise frequency 3 sets 10 repetitions |
Intervention |
internal rotation group |
Group 2 : internal rotation of SLR
Quadriceps strengthening exercises
intervention given for 2 weeks
5 Exercises
Each exercise frequency 3 sets 10 repetitions |
Intervention |
neutral group |
Group 1 : Neutral position SLR
quadriceps strengthening exercise
intervention given for 2 weeks
5 exercises
Each exercise frequency 3 sets and 10 repetitions |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Age 41-60 years group
2. Gender both male and female.
3. Unilateral knee involvement
4. Patients with bicompartmental degenerative joint disease of knee.
|
|
ExclusionCriteria |
Details |
1. Patellofemoral arthritis
2. Knee Instability
3. Recent trauma
4. Open wounds or infections
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
EMG (Electromyography) |
2 points (baseline and 2 weeks) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Dynamometer (strength) |
2 points (baseline and 2 weeks) |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
20/09/2022 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Degenerative joint disease is referred to as wear and tear arthritis, as one of the main reasons causing it is the repetitive use of the weight-bearing joints. It is predominantly experienced in hips, knees, and hands. Quadriceps play a vital role in almost all of our leg movements, so it is basically necessary to maintain them strong and flexible. SLR is an essential part of exercise therapy programs in the treatment of degenerative joint disease. Contribution of Quadriceps plays a major role during SLR exercise. Hip rotational positions can affect the recruitment pattern of Quadriceps muscle. This may in turn affect the efficiency of Quadriceps which may alter the ideal force production. Hence, it is vital to find the hip position that causes maximal quadriceps recruitment. This would enable maximum muscle performance and minimize energy expenditure. Also, there has been recommendation in past studies to analyze Straight Leg Raise at different hip positions. The purpose of the study is to analyze the recruitment pattern of quadriceps during SLR exercise. The study participants would be allocated into 3 groups namely: Groups 1, 2 & 3. Group 1 would be performing ASLR with hip in Internal rotation position, Group 2 would be performing ASLR in Neutral position and Group 3 would be performing ASLR in External rotation position. During the exercise, baseline measures in relation to recruitment of Quadriceps (EMG and IMS) would be obtained. The device to be used for EMG analysis is Neurotrac Myoplus 4 pro and for IMS is push pull dynamometer. |