NCT05088122

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

October 8, 2021

Last Update Submit

October 20, 2021

Conditions

Keywords

Sex hormones, Postural stability, Menstrual cycle.

Outcome Measures

Primary Outcomes (4)

  • serum estradiol level

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

    two months

  • Anetro-posterior stability index

    Indicator for dynamic postural stability

    two months

  • Medio-lateral stability index

    Indicator for dynamic postural stability

    two months

  • Overall stability index

    Indicator for dynamic postural stability

    two months

Study Arms (1)

one group

Other: no intervention

Interventions

no intervention, not applicable

one group

Eligibility Criteria

Age16 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • All females will be virginal.
  • Their ages will range from 15-25 years.
  • Their body mass index (BMI) will range from 18-27 kg/m2.
  • All females will have regular menstrual cycle within average of 28 days.

You may not qualify if:

  • Females having menstrual irregularity.
  • Use of oral contraceptives or any hormonal treatment in the previous six months before participate in this study.
  • History of lower extremity injury, surgery or pain during ADL.
  • Females having any vestibular problems , otitis media, labyrinthitis or any inner ear problems that affect balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Manal A. el-shafei, lecturer

CONTACT

Hager M.E. Abd-elaziz, Demonstrator

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of physical therapy for women health at deraya university

Study Record Dates

First Submitted

October 8, 2021

First Posted

October 21, 2021

Study Start

October 15, 2021

Primary Completion

December 25, 2021

Study Completion

January 25, 2022

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF