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Hormonal Effect of Different Menstrual Phases on Dynamic Balance in Postpubertal Females

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05088122
Collaborator
(none)
36
Enrollment
3.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

High rate of injuries detected during certain periods of menstrual cycle, raised the suggestion of the effecacy of the female sex hormones on soft tissue and neuromuscular control with subsequent deterioration of postural stability and high injury prevalence in post pubertal females so the aim of the present study is to investigate the effect of female sex hormones on postural stability in post pubertal females.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Detailed Description

Thirty-six post pubertal females will participate in this study. They will be selected from students and graduates of Faculty of Physical Therapy, Deraya University and they will be assigned into one group. Postural stability assessment will be carried out throughout three menstrual cycle phases, early follicular, ovulation and mid luteal phases by Biodex balance system. The timing of menstrual cycle phases will be determined by measuring serum estradiol and progesterone level. The exact time of ovulation will be determined by urine lutenizing hormone ovulatory strip test.

Study Design

Study Type:
Observational
Anticipated Enrollment :
36 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Hormonal Effect Of Different Phases Of Menstrual Cycle On Postural Stability In Postpubertal Females: A Cross Sectional Repeated Measure Design
Anticipated Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Dec 25, 2021
Anticipated Study Completion Date :
Jan 25, 2022

Arms and Interventions

Arm Intervention/Treatment
one group

Other: no intervention
no intervention, not applicable

Outcome Measures

Primary Outcome Measures

  1. serum estradiol level [two months]

    used for accurate timing of menstrual cycle phases, follicular and midluteal.

  2. Anetro-posterior stability index [two months]

    Indicator for dynamic postural stability

  3. Medio-lateral stability index [two months]

    Indicator for dynamic postural stability

  4. Overall stability index [two months]

    Indicator for dynamic postural stability

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. All females will be virginal.

  2. Their ages will range from 15-25 years.

  3. Their body mass index (BMI) will range from 18-27 kg/m2.

  4. All females will have regular menstrual cycle within average of 28 days.

Exclusion Criteria:

  1. Females having menstrual irregularity.

  2. Use of oral contraceptives or any hormonal treatment in the previous six months before participate in this study.

  3. History of lower extremity injury, surgery or pain during ADL.

  4. Females having any vestibular problems , otitis media, labyrinthitis or any inner ear problems that affect balance.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hager Mohey Eldien Abdel Aziz Mahmoud, Demonstrator of physical therapy for women health at deraya university, Cairo University
ClinicalTrials.gov Identifier:
NCT05088122
Other Study ID Numbers:
  • P.T.REC/012/003102
First Posted:
Oct 21, 2021
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hager Mohey Eldien Abdel Aziz Mahmoud, Demonstrator of physical therapy for women health at deraya university, Cairo University
Sex hormones, Postural stability, Menstrual cycle.

Study Results

No Results Posted as of Oct 21, 2021