| 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
|
|
|
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
|
|
|
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. |