NCT07239232

Brief Summary

The purpose of the study is to assess knee joint position sense, pain and dynamic balance in female with primary dysmenorrhea.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

November 18, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

November 16, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

KneePosition senseBalancePrimary Dysmenorrhea

Outcome Measures

Primary Outcomes (4)

  • Overall Stability Index (OSI) . Antero-posterior stability index score (APSI) . Medio lateral stability index score (MLSI) . Over all stability index score (OASI)

    The Overall Stability Index (OSI) is the primary measure of dynamic postural control obtained from the balance assessment system. It reflects the standard deviation of the participant's sway from the platform's center across both the medial-lateral and anterior-posterior directions. Higher OSI values indicate greater instability and poorer balance performance. As an integrated measure of sway variability, the OSI is considered the most comprehensive indicator of overall balance ability and is commonly used to evaluate changes in postural control in response to therapeutic interventions.

    at first and fourth menstrual days

  • Medial-Lateral Stability Index (MLSI)

    The Medial-Lateral Stability Index (MLSI) quantifies the degree of side-to-side sway during balance testing. It represents the standard deviation of medial-lateral movement from the platform's center point, providing a directional measure of postural stability. Elevated MLSI scores reflect increased lateral instability, which may be associated with impaired neuromuscular control or deficits in weight-shifting ability. This variable is useful for identifying balance impairments that predominantly affect frontal plane stability.

    at first and fourth menstrual days

  • Anterior-Posterior Stability Index (APSI)

    The Anterior-Posterior Stability Index (APSI) measures front-to-back sway during dynamic balance assessment. Calculated as the standard deviation of anterior-posterior deviations from the center of the platform, the APSI provides insight into sagittal plane stability. Higher APSI values indicate greater instability and reduced capacity to control forward and backward movements. This index is important for evaluating postural control related to gait, stepping, and activities requiring controlled anterior or posterior shifts in the center of gravity.

    at first and fourth menstrual days

  • knee joint position sense

    using active knee position sense test by universal goniometer.

    at first and fourth menstrual days

Secondary Outcomes (1)

  • knee joint pain

    at first and fourth menstrual days

Study Arms (2)

Asymptomatic Group

They have no or mild primary dysmenorrhea.

Other: No intervention

Symptomatic Group

They have moderate and sever primary dysmenorrhea.

Other: No intervention

Interventions

No intervention

Asymptomatic GroupSymptomatic Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Sixty-two healthy female university students will participate in this study. They will be selected randomly from faculty of physical therapy, Cairo University.

You may qualify if:

  • They should be virgin, healthy female students
  • They have regular menstruation (3-8 days in duration, with 21-35 days in-between).
  • They should have the same activity level mild active female.
  • Their ages will range from 18 to 25 years old.
  • Their body mass index (BMI) will range from 18 to 24.9 Kg/m2.

You may not qualify if:

  • History of knee injury, surgery in the knee or spinal vertebrae.
  • Females having any vestibular problems, otitis media, labyrinthitis or any inner ear problems that affect balance
  • Women with any cognitive deficits
  • History of neuromuscular or spinal disease.
  • History of pelvic pathology or any gynecological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

Study Officials

  • AFAF M BOTLA, PhD

    Assistant Professor, Cairo University

    STUDY CHAIR
  • ELHAM s HASSAN, PhD

    Lecturer, Cairo university

    STUDY DIRECTOR

Central Study Contacts

Eman B ABDUL HAMID, B.Sc

CONTACT

ELHAM s HASSAN, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

November 18, 2025

Primary Completion

January 20, 2026

Study Completion

January 30, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations