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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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