- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07239232
"Knee Joint Position Sense and Dynamic Balance in Females With Primary Dysmenorrhea
Assessment Of Knee Joint Position Sense And Dynamic Balance IN Female With Primary Dysmenorrhea
Study Overview
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: EMAN B ABDUL HAMID, B.Sc
- Phone Number: 01158876852
- Email: emanahmed2033e@gmail.com
Study Contact Backup
- Name: ELHAM s HASSAN, PhD
- Phone Number: 01206146539
- Email: elhamramdan70@cu.edu.eg
Study Locations
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-
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Giza, Egypt
- Recruiting
- Cairo University
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Contact:
- EMAN B ABDUL HAMID, B.Sc
- Phone Number: 01158876852
- Email: emanahmed2033e@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Asymptomatic Group
They have no or mild primary dysmenorrhea.
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No intervention
|
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Symptomatic Group
They have moderate and sever primary dysmenorrhea.
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No intervention
|
What is the study measuring?
Primary Outcome Measures
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.
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at first and fourth menstrual days
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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.
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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.
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at first and fourth menstrual days
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knee joint position sense
Time Frame: at first and fourth menstrual days
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using active knee position sense test by universal goniometer.
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at first and fourth menstrual days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
knee joint pain
Time Frame: at first and fourth menstrual days
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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
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at first and fourth menstrual days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
knee joint pain
Time Frame: at first and fourth menstrual day
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using visual analouge scale
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at first and fourth menstrual day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: AFAF M BOTLA, PhD, Assistant Professor, Cairo university
- Study Director: ELHAM s HASSAN, PhD, Lecturer, Cairo university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P.T.REC/012/005972
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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