| 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 |
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Type of Study
|
longitudinal study |
| Study Design |
Other |
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Public Title of Study
|
Understanding of position of knee joint in different phases of menstrual cycle(periods) in healthy basketball female athletes. |
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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
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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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. |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sancheti institute for orthopaedics and rehabilitationr |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal healthy basketball female athletes |
|
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Intervention / Comparator Agent
|
|
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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. |
|
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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 |
|
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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 deï¬ned 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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