"Knee Joint Position Sense and Dynamic Balance in Females With Primary Dysmenorrhea

December 5, 2025 updated by: Eman Belal Ahmed, Cairo University

Assessment Of Knee Joint Position Sense And Dynamic Balance IN Female With Primary Dysmenorrhea

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dysmenorrhea is a common condition that typically occurs on its own rather than as a result of pelvic disease. It affects between 50% and 90% of adolescent girls and women of reproductive age and is a major reason for missed days from school or work.

Among the various menstrual disturbances observed, dysmenorrhea was notably prevalent among adolescents and significantly impacted their daily activities. Early diagnosis and awareness of menstrual issues are crucial, as they not only emphasize the need for health education initiatives but also assist in selecting suitable treatments, thereby reducing the adverse effects of these disturbances on adolescents' lives.

However, there is a significant gap in the literature about the effect of Primary dysmenorrhea on knee joint position sense, pain and dynamic balance in young adult female So this study aims to investigate this effect and provide evidence based information in the field of physical therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Asymptomatic Group
They have no or mild primary dysmenorrhea.
Other: No intervention
No intervention
Symptomatic Group
They have moderate and sever primary dysmenorrhea.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Stability Index (OSI) . Antero-posterior stability index score (APSI) . Medio lateral stability index score (MLSI) . Over all stability index score (OASI)
Time Frame: at first and fourth menstrual days
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)
Time Frame: at first and fourth menstrual days
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)
Time Frame: at first and fourth menstrual days
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
Time Frame: at first and fourth menstrual days
using active knee position sense test by universal goniometer.
at first and fourth menstrual days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
knee joint pain
Time Frame: at first and fourth menstrual days
It will be assessed using the Visual analog scale (VAS) for all females in both groups. They will score their level of pain from 1-10, with higher scores indicating more severe pain. It is valid and reliable in pain assessment
at first and fourth menstrual days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
knee joint pain
Time Frame: at first and fourth menstrual day
using visual analouge scale
at first and fourth menstrual day

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: AFAF M BOTLA, PhD, Assistant Professor, Cairo university
  • Study Director: ELHAM s HASSAN, PhD, Lecturer, 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/005972

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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