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CTRI Number  CTRI/2018/07/014857 [Registered on: 13/07/2018] Trial Registered Prospectively
Last Modified On: 11/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   longitudinal study 
Study Design  Other 
Public Title of Study   Understanding of position of knee joint in different phases of menstrual cycle(periods) in healthy basketball female athletes. 
Scientific Title of Study   Variation in knee joint position sense during different menstrual phases in healthy female basketball athletes – a longitudinal study. 
Trial Acronym  JPS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR MRUNMAYEE BORKAR 
Designation  MPTh student 
Affiliation  SANCHETI INSTITUTE COLLEGE OF PHYSIOTHERAPY 
Address  Sancheti Health-care Academy, sancheti institute college of physiotherapy, 1st floor, community physiotherapy department,11/12,Thube park, Shivajinagar, Pune.

Pune
MAHARASHTRA
411005
India 
Phone  020-25539393  
Fax    
Email  mrunmayeesb7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR APURV SHIMPI 
Designation  PROFESSOR 
Affiliation  SANCHETI INSTITUTE COLLEGE OF PHYSIOTHERAPY 
Address  Sancheti Health-care Academy, sancheti institute college of physiotherapy, 1st floor, community physiotherapy department,11/12,Thube park, Shivajinagar, Pune.

Pune
MAHARASHTRA
411005
India 
Phone  020-25539393  
Fax    
Email  apurv008@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DRAPURV SHIMPI 
Designation  PROFESSOR 
Affiliation  SANCHETI INSTITUTE COLLEGE OF PHYSIOTHERAPY 
Address  Sancheti Health-care Academy, sancheti institute college of physiotherapy, 1st floor, community physiotherapy department,11/12,Thube park, Shivajinagar, Pune.

Pune
MAHARASHTRA
411005
India 
Phone  020-25539393  
Fax    
Email  apurv008@gmail.com  
 
Source of Monetary or Material Support  
Dr. mrunmayee Borkar Sancheti Health-care Academy, sancheti institute college of physiotherapy, 1st floor, community physiotherapy department,11/12,Thube park, Shivajinagar, Pune. 
 
Primary Sponsor  
Name  MRUNMAYEE BORKAR 
Address  Sancheti Health-care Academy, sancheti institute college of physiotherapy, 1st floor, community physiotherapy department,11/12,Thube park, Shivajinagar, Pune. 
Type of Sponsor  Other [self] 
 
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 MRUNMAYEE BORKAR  BASKETBALL CLUBS OF PUNE CITY  C.M. INTERNATIONAL SCHOOL, BASKETBALL CLUB, BALEWADI. PUNE
Pune
MAHARASHTRA 
7719006060

mrunmayeesb7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sancheti institute for orthopaedics and rehabilitationr  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  normal healthy basketball female athletes  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1) Female basketball athletes.
2) Regular menses.
3) Age group- 15 to 25
4) Playing atleast at zonal level
 
 
ExclusionCriteria 
Details  1) Pregnant athletes.
2) Irregular menses.
3) On hormonal supplements and taking Oral Contraceptive Pills.
4) Trauma/ injuries to lower limb within past 6 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knee joint position sense,   will be assessed 3 times in a month, in 3 different phases of menstrual cycle- menstrual phase,ovulatory phase, luteal phase for concurrent 2 months.  
 
Secondary Outcome  
Outcome  TimePoints 
vertical jump test, hop test  will be assessed 3 times in a month, in 3 different phases of menstrual cycle- menstrual phase,ovulatory phase, luteal phase for concurrent 2 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/08/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Variation in knee joint position sense during different menstrual phases in healthy female basketball athletes – a longitudinal study.


Introduction

A period, or menstruation, is the shedding of the endometrium - the lining of the uterus. Menstruation is part of normal sexual health for women during reproductive age. Women have a period approximately every 28 days; however, there is some variation in this cycle, ranging from a 24-day to a 35-day cycle. Dr. Puala Hillard,(2016) said: "The menstrual cycle is a window into the general health and well-being of women and not just a reproductive event."

There is evidence that females are more prone for exercise- related musculoskeletal injuries than males. Sex differences in injury rates are apparent in some connective tissues such as ligaments. Although girls and boys have an equal chance of ligament injuries prior to adolescence, girls have a higher rate immediately after maturation (Tursz et al., 1986). Female athletes participating in cutting, jumping and pivoting sports have a 4-6 times greater chance of ACL tearing than their male counterparts (Arendt et al., 1999).Female basketball players are two to eight times more likelyto sustain an ACL tear while playing basketball than are their male counterparts.Long term exposure to highoestrogen levels has been shown to significantly decrease the collagen density of  tissue structures (Lee et al., 2004; Liu et al;1996; Miller et al., 2007) decreasing the stability of the joints which may expose them to risk of injuries of ligaments and other soft tissues because estrogen causes laxity at joints, ligaments.Hormone fluctuations in females have been identified as placing women at higher risks of injuries at certain times during the menstrual cycles as there is affection of joint position sense.Women have been shown to be more likely to injure their ACL during the pre-ovulatory phase of the menstrual cycle (Hewett et al., 2007; Shultz et al., (2010)

When female athletes are part of a  sport like Basketball, in which they cover almost 4000-5000m distance with intense and short lasting movements (Crisafulli et al,2000) such as jumping, pivoting, cutting, sprinting, sudden acceleration(Boon and Bourguis,2013), they are at high risk of getting  injured. In basketball, mostly injured joints are ankle and knee (Moira M. McCarthy, et al, AJSM, 2013) .  ACL injuries are very common with pivoting and cutting actions(Moira M. McCarthy, et.al, AJSM, 2013)

As per the studies done,the changes in the levels of these hormones have some effects on bones, soft tissues, central nervous system and connective.(Sedat Tolga Aydog˘ Zafer Hasc¸ elik H. Ali Demirel Onur Tetik Ece Aydog˘ Mahmut Nedim Doral, 2002)

Evidence suggest that menstruation can lead to changes in anterior knee laxity, jumping biomechanics, tibial torsion, neuromuscular control of the female athletes (Vivek Balachandar, Jan-Luigi Marciniak, Owen  Wall, Chandrika Balachandar, A systematic review, (2017)Neuromuscular control of the knee is defined as the unconscious response to an afferent signal concerning dynamic knee joint stability. These afferent signals are produced by Proprioception which refers specially to conscious and unconscious appreciation of joint position, kinesthesia (the sensation of joint motion or acceleration) and the perception of force (an ability to estimate joint loads). These signals are transmitted to the spinal cord via afferent (sensory) pathways.as Proprioception is an important part of neuromuscular performance, and can be defined as the individual’s awareness of his or her extremities’ position and motion in space.Rose Fouladi(2011)found out in his study that accuracy of joint position sense is reduced during menses. Sandra Schultz et al. (2012) , performed similar study which showed that knee joint position sense is affected in ovulatory phase.

Aim

To assess the Variations in knee joints position sense during different menstrual phases in healthy female basketball athletes.


Objectives-

1)     1. To assess static and dynamic (functional) Knee Joint Position Sensein

a.       Early follicular phase.

b.      Ovulatory phase.

c.       Late luteal phase.

2)      2. To compare variationin Knee Joint Position Sense, if any, between these three phases.


MMethodology-

1) Study design- Longitudinal study.

2) Sample size- 50


3SSampling technique- Convenient sampling.

4) Sample population- healthy female basketball athletes.

5) Study set-up- Basketball clubs in Pune.

AsAsessment tools- MB ruler software, Measuring tape,  Smartphone, Digital camera,     Skin markers .

  Every participant will be assessed 3 times in a month for 2 concurrent months, with  joint position sense, vertical jump test and hop test. every test would be conducted three times and mean would be considered. data analysis would be done with ANOVA test.



       


          

 





 
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