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

Menstrual Cycle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05088122
• Other study ID #: P.T.REC/012/003102
• Status: Not yet recruiting
• Start date: October 15, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: October 2021
• Source: Cairo University
• Contact: Manal A. el-shafei, lecturer
• Phone: 00201220664518
• Email: manalpt1989[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: January 25, 2022
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menstrual Cycle

Intervention

Other:
• no intervention
no intervention, not applicable

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

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