The Effect of Oral Contraceptives on Women Balance
Condition: Joint Stabilioty
Study type: Interventional
Phase: Phase 4

Summary: 
      1. Recording Data Sheet:

           All data and information of each woman in both groups (A & B) participated in this study
           were recorded in a recording data sheet (Appendix II).

        2. Weight-Height scale:

           A valid and reliable weight -height scale, with a range of 1 to 150 kilograms weight,
           and 1 to 200 centimeters height was used to measure the relevant subject's data.

        3. Siemens Immulite Immunoassay System:

           (Siemens Medical Solutions Diagnostics Immulite 1000,Los Angles, CA, 900-456900 U.S.A)
           to measure the serum Progesterone and Estradiol levels in both groups (A& B) using (TKE
           21 Kit) for Estradiol and (TKPG 1 Kit) for Progesterone.

        4. Biodex balance system:

      Biodex Balance System (BBS), P.O. Box 702, Shirley, Ny 11967.It is an apparatus used to
      measure the dynamic balance. It utilizes dynamic multi axial platform. This platform allows
      approximately 20 degree inclination in 360 degree range and is interfaced with computer
      software. It measures the patient's ability to control the platform's angle of tilt, which is
      quantified as a variance from the center, as well as the degree of deflection over time at
      various stability levels as shown in (Fig. 6).

      Stability levels allowed by the system ranged from one to eight. Stability level 8, allows
      the highest level of stability as it makes the platform to be the least tilted. On the other
      hand, stability level one represents the least level of stability and is more difficult for
      the subject to maintain stability on.

      The test consists of recording the patient's ability to control the platform variance from a
      perfectly balanced position. A large variance is indicative of poor control and balance.
      Further definition is realized with the quantification of Anterior/ Posterior and
      Medial/Lateral responses.
    

Detailed description: 
      1. Recording Data Sheet:

           All data and information of each woman in both groups (A & B) participated in this study
           were recorded in a recording data sheet.

        2. Weight-Height scale:

           A valid and reliable weight -height scale, with a range of 1 to 150 kilograms weight,
           and 1 to 200 centimeters height was used to measure the relevant subject's data.

        3. Siemens Immulite Immunoassay System:

           (Siemens Medical Solutions Diagnostics Immulite 1000,Los Angles, CA, 900-456900 U.S.A)
           to measure the serum Progesterone and Estradiol levels in both groups (A& B) using (TKE
           21 Kit) for Estradiol and (TKPG 1 Kit) for Progesterone.

        4. Biodex balance system:

      Biodex Balance System (BBS), P.O. Box 702, Shirley, Ny 11967.It is an apparatus used to
      measure the dynamic balance. It utilizes dynamic multi axial platform. This platform allows
      approximately 20 degree inclination in 360 degree range and is interfaced with computer
      software. It measures the patient's ability to control the platform's angle of tilt, which is
      quantified as a variance from the center, as well as the degree of deflection over time at
      various stability levels as shown in .

      Stability levels allowed by the system ranged from one to eight. Stability level 8, allows
      the highest level of stability as it makes the platform to be the least tilted. On the other
      hand, stability level one represents the least level of stability and is more difficult for
      the subject to maintain stability on.

      The test consists of recording the patient's ability to control the platform variance from a
      perfectly balanced position. A large variance is indicative of poor control and balance.
      Further definition is realized with the quantification of Anterior/ Posterior and
      Medial/Lateral responses.

      The BBS Consists of the Following:

        -  Display Screen: Its height can be adjusted from 51cm to 68 cm above the platform.
           Display angle of the screen can be adjusted from vertical back up to 45º. Display
           viewing area: 122 mms x 92 mms. Display accuracy: ±1 degree of tilt.

        -  Support Handle Rails: Adjustable from 125 cm to 136.5 cm above the platform. The rails
           can be swung away from the platform if desired.

        -  Platform: Its height is 8 cm above floor, with a diameter of 21.5 cm. The platform has a
           grid which consists of two coordinates: X and Y. The platform X coordinate is marked in
           numbers from 1 to 21, whereas the platform Y coordinate is marked in letters from A to
           P, the platform is also marked in angles from 0º to 45º, for precise feet placement and
           documentation of the subject during the test procedures .

        -  Printer: Cannon Bubble-Jet Printer, centronics parallel interface.

      Stability levels:

      - Biodex balance system has been allowed for eight stability levels, which has been ranged
      from stability level (1) to stability level (8).which allows setting up of the test
      parameters.

      Stability indices:

        -  The woman's ability to control the platform's angle of tilt measured by the system.The
           woman's performance wasnoted as a stability index.

        -  The stability index represents the variance of platform displacement in degrees from
           level. A high number is an indicative of a lot of motion, which indicates balance
           problem.

        -  The data regarding the balance of the tested woman were supplied to the system. These
           data includesantero-posterior stability index (APSI), medio-lateral stability index
           (MLSI) &overall stability index (OSI).

        -  On the upper most part of the surface of the platform appear angles from 0o to 95o with
           the lines which represents these angles. These lines would be used to measure foot
           angle.

        -  The smaller the amount of sway, the lower the numerical value of these indices.

        -  Over all stability index (OSI): Represents the woman's ability to control her balance in
           all directions.

        -  Anterior/Posterior stability index (APSI): Representsthe woman's ability to control her
           balance in front to back directions (sagittal plane).

        -  Medial/Lateral stability index (MLSI): Represents the woman's ability to control her
           balance from side to side directions(frontal plane).

      III-Methods:

      The evaluation procedures were explained in details for every woman in both groups (A&B) to
      increase her interest and co-operation.

      Body Mass Index

      The data of each woman in both groups were taken according to items of the recording data
      sheet then, the weight and height were measured and BMI was calculated according to the
      following equation BMI = Weight/Height (Kg/m2)

      Blood sampling

      Evening Blood sample was collected from each woman to limit the effect of hormone diurnal
      variations,For both groups samples have been collected at mid-luteal phase (20th to 23th days
      of the cycle), at Al-Madina Lab.

      The sample was allowed to clot in water bath at room temperature.the serum was separated
      using a centrifuge at 4000 rmp for 15 min.Then using the TKE 21 and TKPG 1 Kits in a low
      temperature air conditioned room to measure serum Estradiol and Progesterone levels.

      Biodex balance system:

      The procedures were performed in dynamic balance lab at physical therapy faculty
      CairoUniversity.

      Biodex Balance System used for assessment of the postural stability in female oral
      contraceptive users and non-users. The assessment was conducted for each woman individually.

      The protocol of the work was explained to the woman before conducting this study.

      A) Biodex balance system:

      Operating the balance system:

        -  When the system is on, the first displayed screen showed the main menu. It allowed us to
           choose entering test or system utilities.

        -  Choosing to enter testing showed the next screen, which allowed for determining the test
           parameters as test duration and the stability levels were chosen as the initial
           stability level (8) and the end stability level (4).

        -  The next screen was used for centering process.

        -  The next screen was the stability test screen. The start key was pressed while on this
           screen to unlock the platform allowing the test to start. A cursor appeared during the
           test tracing the movement of the platform while the timer counting till the time of the
           test ends.

        -  The duration of test lasts for 20 seconds staring with stability level (8) and
           progressing the stability levels ending with stability level (4)

        -  The foot platform automatically returned to the locked position. At this point, the
           investigators printed the screen, including the numeric value of the APSI, MLSI and OSI.

      Testing Protocol:

        -  Testing procedures was done at mid-luteal phase (20th to 23th days of the cycle). Each
           woman was received verbal explanation about the test steps.

        -  The woman was tested without footwear and with eyes opened.

        -  Two test trials was done before specific test condition for the purpose of instrument
           familiarity prior to data collection.

        -  A high stability level (stability level 8) and reduced test time (20 sec) was chosen to
           avoid falling.

        -  Each woman was asked to perform two trial tests and their mean was calculated.

        -  Each test started with the balance platform in the locked position and standing on its
           center.

      Preparatory step: the parameters of each examined woman (weight, height and age) as well as,
      test duration and stability level of the platform of the BBS were typed to the software of
      the device as shown in Fig. (8). All woman were asked to stand on the platform of the BBS in
      an erect posture as possible and kept it all through the test duration (i.e. stand on both
      feet, chin in, shoulders were leveled, as well as, retracted , back was straight and knees
      were drawn backward). Hence, the support handle rails and display screen were adjusted
      according to the height of each examined woman.

      Centering step: with the aim of positioning the center of gravity (COG) of the subject at the
      middle of her base of support between the two feet and recoding the women's feet position.
      Centering was achieved by asking each woman to stand on the platform of the BBS while
      grasping the support handle rails by both hands while the platform was locked . Formerly, the
      platform was unlocked at stability level 8, the display screen showed a circle with a central
      cursor. At that time, the subject was asked to achieve a central position on the platform by
      shifting her feet position until she was able to keep the cursor (which represents the center
      of platform) centered on the circle that appeared on the display screen and correspondingly
      the platform was kept easily leveled.

      - Once centering was achieved and the cursor was in the center of the display screen, each
      woman was instructed to maintain her feet at that position constant until the end of test
      procedures. At that time, the platform was locked again to allow recording the feet angles
      and heel's coordinates from the platform grid. The heel's coordinates were determined by
      finding the location of the center of the back of each heel in relation to X and Y
      coordinates of the platform, while the feet angles were determined by finding a line on the
      platform parallel to the 2nd metatarsal bone of each foot. Then, the feet angles and heels
      coordinates for each womanwere entered to the software of the BBS
    

Intervention name(s): COC containing 30 μg of EE and 3mg of drospirenone
Intervention type(s): Drug
Intervention description(s): treatment for 6 consecutive cycles. Each treatment cycle consisted of 3 weeks of pill treatment followed by a 1-week pill-free period.
Other intervention name(s): Yasmin; Schering AG, Berlin, Germany
Intervention MeSH terms: Drospirenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: oral contraceptive pills; Joint stability