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CTRI Number  CTRI/2024/10/074813 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 02/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Correlational Study 
Study Design  Single Arm Study 
Public Title of Study   A study to find association between Quadriceps angle and balance among young females 
Scientific Title of Study   Correlation between Quadriceps angle and balance among young females 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhilasha Singh 
Designation  Student  
Affiliation  School of Health Sciences/ Chhatrapati Shahuji Maharaj University, Kanpur 
Address  School of Health Sciences, Department of Physiotherapy SHS 106, CSJMU, Kanpur
Chhatrapati Shahuji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  8271155040  
Fax    
Email  abhilashasingh03082000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandra Shekhar Kumar PT 
Designation  Assistant Professor 
Affiliation  School of Health Sciences/ Chhatrapati Shahuji Maharaj University 
Address  School of Health Sciences, Department of Physiotherapy, SHS 128, CSJMU Kanpur
Chhatrapati Shahuji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9919630553  
Fax    
Email  chandrasekhar@csjmu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Chandra Shekhar Kumar PT 
Designation  Assistant Professor 
Affiliation  School of Health Sciences/ Chhatrapati Shahuji Maharaj University, Kanpur 
Address  School of Health Sciences, Department of Physiotherapy, SHS 128, CSJMU, Kanpur
Chhatrapati Shahuji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9919630553  
Fax    
Email  chandrasekhar@csjmu.ac.in  
 
Source of Monetary or Material Support  
School of Health Sciences, Department of Physiotherapy, SHS 106, CSJMU, Kanpur 
 
Primary Sponsor  
Name  School of Health Sciences 
Address  School of Health Sciences, Chhatrapati Shahuji Maharaj University, Kanpur, Uttar Pradesh India 208012 
Type of Sponsor  Research institution 
 
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 
Dr Chandra Shekhar Kumar PT   School of Health Sciences Physiotherapy OPD  Department of Physiotherapy, Rehabilitation Unit, SHS 106, CSJMU, Kalyanpur, Kanpur
Kanpur Nagar
UTTAR PRADESH 
9919630553

chandrasekhar@csjmu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethical Committee, CSJMU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Females between the age of 18 and 30 years, with a BMI within the range of 18.5 to 24.9 and they should not be using analgesics or any medication that would affect the balance prior to the assessment. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Females between the age of 18 and 30 years, with a BMI within the range of 18.5 to 24.9 and they should not be using analgesics or any medication that would affect the balance prior to the assessment. 
 
ExclusionCriteria 
Details  1) Participants who underwent any, ankle, foot, knee and spinal surgery in the past 1 year. 2) Pregnant woman. 3) Previous history of immobilization in last 3 years. 4) Participants with active lower limb injury. 5) Persistent pain due to underlying pathologies like patellar bursitis, osteoarthritis of hip and knee, achilles tendinitis, patellofemoral pain syndrome, etc. 6) Having severe psychological disorders. 7) Having any kind of neuromuscular disorder in the lower limb and radiculopathy. 8) Participants with visual and vestibular impairments like nystagmus. 9) Having neurological disorders like vertigo.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Stork stance test to assess static balance and Y balance test to assess dynamic balance.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="134"
Sample Size from India="134" 
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)   21/10/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

INTRODUCTION

The quadriceps angle is an anatomical variable that gives insight into the alignment of the knee joint and the alignment of the femur and tibia in the frontal plane. Studies have suggested an increased quadriceps angle has been considered a risk factor for many disorders and injuries. A higher quadriceps angle has been linked to greater femoral anteversion, increased anterior pelvic tilt, increased kneevalgus, excessive external tibial rotation, and patellar and foot position. 

The alignment of lower extremity structures can have a significant impact on postural control strategies and stability, especially among females. Any changes in structural alignment can increase the risk of lower limb injuries in females. However, there are inconsistent conclusions in the literature regarding this topic.

There have been studies on the effects of quadriceps angle on young adults’ balance, but none have specifically looked at the relationship between quadriceps angle and static & dynamic balance in females.

Thus, it is important to ascertain the correlation in order to estimate the likelihood of potential future musculoskeletal injuries, enhance rehabilitation strategies, and optimize performance, especially in sports and clinical settings. This can also aid in predicting potential treatments if any abnormalities are detected.

METHODOLOGY –

This will be a correlational study and will be conducted in Physiotherapy OPD, School of Health Sciences, Kanpur. The sample will be collected by the purposive sampling method based on inclusion and exclusion criteria. Prior to the participant’s enrolment in the research, each participant will receive an informed consent form for their voluntary participation. 

Every participant’s demographic information, including age, gender, and address, will be documented, and the entire testing procedure will be explained. Each participant will complete the assessment without wearing any footwear. The tests will be terminated at any point during the entire process if the participant feels uncomfortable. Quadriceps angle will be measured first using a goniometer, and it will be followed by balance tests. Static balance will be assessed by the Stork stance test, and dynamic balance will be assessed by the Y balance test. One trial will be given, and final readings will be recorded for each test. Enough rest period will be given between each test and trial to avoid fatigue for the participant.

DISCUSSION This study will help society by offering insightful information about musculoskeletal health. This study has practical implications in injury prevention, especially in the female population, rehabilitation, performance enhancement, and clinical assessment, offering a more comprehensive approach to patient care. This can also aid in predicting potential treatment if abnormalities are detected. The study will comply with ethical guidelines and will not harm the participants.

 

 
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