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

October 20, 2021 updated by: Hager Mohey Eldien Abdel Aziz Mahmoud, Cairo University

Hormonal Effect Of Different Phases Of Menstrual Cycle On Postural Stability In Postpubertal Females: A Cross Sectional Repeated Measure Design

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Thirty-six, healthy postpubertal females , their ages will be ranged from 16-25 and BMI will be ranged from 18-27kg/m2, with regular menstrual cycle and with no any health condition that can affect the balance performance

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
one group
Other: no intervention
no intervention, not applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum estradiol level
Time Frame: two months
used for accurate timing of menstrual cycle phases, follicular and midluteal.
two months
Anetro-posterior stability index
Time Frame: two months
Indicator for dynamic postural stability
two months
Medio-lateral stability index
Time Frame: two months
Indicator for dynamic postural stability
two months
Overall stability index
Time Frame: two months
Indicator for dynamic postural stability
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2021

Primary Completion (Anticipated)

December 25, 2021

Study Completion (Anticipated)

January 25, 2022

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P.T.REC/012/003102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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