Premenstrual SyndromeNCT07801651
Dual-Task Postural Stability in Women With Premstrual Syndrome: A Within-Subject Comparative Study
An observational study of Premenstrual Syndrome, run by Deraya University at 1 site in Egypt.
Trial summary
This within-subject repeated-measures study investigated dual-task postural stability in women with premenstrual syndrome (PMS) by comparing performance during the PMS and non-PMS phases of the menstrual cycle. The study also examined the relationship between PMS symptom severity and dual-task postural stability. Read more about this study
- Who is it for?
- Ages 18 to 27 years
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- PMS Group
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2026to 20 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 27 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population comprised 40 young adult women (18-27 years) with regular menstrual cycles (19-25 days) and confirmed premenstrual syndrome (PMS) symptoms, recruited from the local community and university setting in Minya, Egypt. Participants were screened using the 40-item Premenstrual Syndrome Scale (PMSS) and excluded if they had dysmenorrhea, recent lower-limb injury, neurological/psychiatric conditions, or were using hormonal contraceptives or medications affecting balance or cognition.
Who may be able to join
- Regular menstrual cycles (19-25 days).
- Presence of premenstrual symptoms identified through menstrual cycle tracking and self-reported symptom reporting.
- No use of hormonal contraceptives.
- No history of neurological, musculoskeletal, vestibular, or cognitive disorders.
Who cannot join
- Lower-limb injury within the previous six months.
- Diagnosed psychiatric or neurological conditions.
- Use of medications affecting balance or cognitive performance.
- Presence of dysmenorrhea symptoms.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of physical therapy, Deraya University
Minya, Menia Governorate
About this study
This within-subject repeated-measures study investigated dual-task postural stability in women with premenstrual syndrome (PMS) by comparing performance during the PMS and non-PMS phases of the menstrual cycle. The study also examined the relationship between PMS symptom severity and dual-task postural stability.
Read the detailed description
Among women of reproductive age, premenstrual syndrome (PMS) is a common condition. Recent evidence indicates that approximately 20-30% of women experience PMS, highlighting its substantial global impact and confirming that a considerable proportion of women are affected by clinically relevant symptoms [1,2]. Estimates suggest that about half of women experience PMS. Fatigue, discomfort, impatience, and trouble concentrating are among the physical, emotional, and cognitive symptoms of PMS that can significantly interfere with day-to-day functioning [3, 4]. In addition to these well-known consequences that may affect balance and postural control, an increasing amount of evidence suggests that PMS may also affect neuromuscular systems and cognitive function [5].
40 women with regular menstrual cycles and premenstrual symptoms were enrolled. Participants were assessed during the PMS phase, identified 5-7 days before menstruation, and the non-PMS follicular phase (days 7-10). PMS symptom severity was assessed using the 40-item Premenstrual Syndrome Scale (PMSS).
Dual-task postural performance was assessed using the Biodex Balance System during static and dynamic conditions. Participants stood barefoot without holding the handrails while performing forward and reverse spelling tasks. Three 30-second trials were performed at Biodex stability levels 6-8, with adequate rest between trials.
Primary outcomes included static and dynamic OSI, APSI, and MLSI, while PMS severity was the secondary outcome. Paired *t*-tests and Cohen's *d* were used to compare the two phases, and Pearson's correlation assessed the relationship between PMS severity and postural stability.
- Conditions
- Premenstrual Syndrome
- Being tested
- PMS Group
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMS GroupOther
A single group of 40 female participants (18-27 years) with regular menstrual cycles and PMS symptoms, each evaluated under two within-subject conditions.
| Study group | Role | What they receive |
|---|---|---|
| PMS Group | A single group of 40 female participants (18-27 years) with regular menstrual cycles and PMS symptoms, each evaluated under two within-subject conditions. Receives: Other: PMS Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Overall Stability Index (OSI)
Measured using the Biodex Balance System during static dual-task testing (standing while performing a concurrent spelling task), comparing non-PMS vs. PMS phase.
Measured: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS (follicular) phase (days 7-10). A within-subject comparison is made.
Static Medial-Lateral Stability Index (MLSI)
Measured using the Biodex Balance System during static dual-task testing (standing while performing a concurrent spelling task). The MLSI represents postural sway in the mediolateral direction during quiet standing.
Unit of measurment: Units on a Scale (Biodex Stability Index)
Measured: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Static Anterior-Posterior Stability Index (APSI)
Measured using the Biodex Balance System during static dual-task testing (standing while performing a concurrent spelling task). The APSI represents postural sway in the anterior-posterior direction during quiet standing.
Measured: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Dynamic Overall Stability Index (OSI)
Measured using the Biodex Balance System during dynamic dual-task testing (standing on an unstable platform while performing a concurrent spelling task). The OSI represents overall postural sway and balance control during dynamic conditions.
Measured: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Dynamic Medial-Lateral Stability Index (MLSI)
Measured using the Biodex Balance System during dynamic dual-task testing (standing on an unstable platform while performing a concurrent spelling task). The MLSI represents postural sway in the mediolateral direction during dynamic conditions.
Measured: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Dynamic Anterior-Posterior Stability Index (APSI)
Measured using the Biodex Balance System during dynamic dual-task testing (standing on an unstable platform while performing a concurrent spelling task). The APSI represents postural sway in the anterior-posterior direction during dynamic conditions.
Measured: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Secondary outcomes (1)
Premenstrual Syndrome (PMS) Symptom Severity
Assessed using the Premenstrual Syndrome Scale (PMSS), a validated 40-item, five-point scale (never to always) covering physiological, psychological, and behavioural symptoms. Total scores range from 40 to 200, with higher scores indicating greater symptom severity. This measure is used to examine the correlation between symptom severity and postural performance.
Measured: Administered during both the non-PMS (follicular) phase (days 7-10) and the PMS phase (5-7 days before menstruation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start15 May 2026
- Primary completion10 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801651
- Sponsor's protocol ID
- PT-USCP-02
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Task Postural Stability in Women With Premstrual Syndrome: A Within-Subject Comparative Study
- ClinicalTrials.gov ID
- NCT07801651
- Acronym / sponsor ID
- PT-USCP-02
- Conditions
- Premenstrual Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This within-subject repeated-measures study investigated dual-task postural stability in women with premenstrual syndrome (PMS) by comparing performance during the PMS and non-PMS phases of the menstrual cycle. The study also examined the relationship between PMS symptom severity and dual-task postural stability.
Detailed description
Among women of reproductive age, premenstrual syndrome (PMS) is a common condition. Recent evidence indicates that approximately 20-30% of women experience PMS, highlighting its substantial global impact and confirming that a considerable proportion of women are affected by clinically relevant symptoms [1,2]. Estimates suggest that about half of women experience PMS. Fatigue, discomfort, impatience, and trouble concentrating are among the physical, emotional, and cognitive symptoms of PMS that can significantly interfere with day-to-day functioning [3, 4]. In addition to these well-known consequences that may affect balance and postural control, an increasing amount of evidence suggests that PMS may also affect neuromuscular systems and cognitive function [5].
40 women with regular menstrual cycles and premenstrual symptoms were enrolled. Participants were assessed during the PMS phase, identified 5-7 days before menstruation, and the non-PMS follicular phase (days 7-10). PMS symptom severity was assessed using the 40-item Premenstrual Syndrome Scale (PMSS).
Dual-task postural performance was assessed using the Biodex Balance System during static and dynamic conditions. Participants stood barefoot without holding the handrails while performing forward and reverse spelling tasks. Three 30-second trials were performed at Biodex stability levels 6-8, with adequate rest between trials.
Primary outcomes included static and dynamic OSI, APSI, and MLSI, while PMS severity was the secondary outcome. Paired *t*-tests and Cohen's *d* were used to compare the two phases, and Pearson's correlation assessed the relationship between PMS severity and postural stability.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PMS Group | – | Other: PMS GroupA single group of 40 female participants (18-27 years) with regular menstrual cycles and PMS symptoms, each evaluated under two within-subject conditions. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population comprised 40 young adult women (18-27 years) with regular menstrual cycles (19-25 days) and confirmed premenstrual syndrome (PMS) symptoms, recruited from the local community and university setting in Minya, Egypt. Participants were screened using the 40-item Premenstrual Syndrome Scale (PMSS) and excluded if they had dysmenorrhea, recent lower-limb injury, neurological/psychiatric conditions, or were using hormonal contraceptives or medications affecting balance or cognition.
Key inclusion criteria (4 listed)
- Regular menstrual cycles (19-25 days).
- Presence of premenstrual symptoms identified through menstrual cycle tracking and self-reported symptom reporting.
- No use of hormonal contraceptives.
- No history of neurological, musculoskeletal, vestibular, or cognitive disorders.
Key exclusion criteria (4 listed)
- Lower-limb injury within the previous six months.
- Diagnosed psychiatric or neurological conditions.
- Use of medications affecting balance or cognitive performance.
- Presence of dysmenorrhea symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMS GroupA single group of 40 female participants (18-27 years) with regular menstrual cycles and PMS symptoms, each evaluated under two within-subject conditions. | Other | PMS Group |
Primary outcome
Static Overall Stability Index (OSI)
Time frame: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS (follicular) phase (days 7-10). A within-subject comparison is made.
Measured using the Biodex Balance System during static dual-task testing (standing while performing a concurrent spelling task), comparing non-PMS vs. PMS phase.
Static Medial-Lateral Stability Index (MLSI)
Time frame: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Measured using the Biodex Balance System during static dual-task testing (standing while performing a concurrent spelling task). The MLSI represents postural sway in the mediolateral direction during quiet standing. Unit of measurment: Units on a Scale (Biodex Stability Index)
Static Anterior-Posterior Stability Index (APSI)
Time frame: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Measured using the Biodex Balance System during static dual-task testing (standing while performing a concurrent spelling task). The APSI represents postural sway in the anterior-posterior direction during quiet standing.
Dynamic Overall Stability Index (OSI)
Time frame: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Measured using the Biodex Balance System during dynamic dual-task testing (standing on an unstable platform while performing a concurrent spelling task). The OSI represents overall postural sway and balance control during dynamic conditions.
Dynamic Medial-Lateral Stability Index (MLSI)
Time frame: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Measured using the Biodex Balance System during dynamic dual-task testing (standing on an unstable platform while performing a concurrent spelling task). The MLSI represents postural sway in the mediolateral direction during dynamic conditions.
Dynamic Anterior-Posterior Stability Index (APSI)
Time frame: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS follicular phase (days 7-10). Within-subject comparison between the two phases.
Measured using the Biodex Balance System during dynamic dual-task testing (standing on an unstable platform while performing a concurrent spelling task). The APSI represents postural sway in the anterior-posterior direction during dynamic conditions.
1 secondary outcome
Premenstrual Syndrome (PMS) Symptom Severity
Time frame: Administered during both the non-PMS (follicular) phase (days 7-10) and the PMS phase (5-7 days before menstruation).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenstrual Syndrome, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Overall Stability Index (OSI) (time frame: Assessed during the PMS phase (5-7 days before menstruation) and the non-PMS (follicular) phase (days 7-10). A within-subject comparison is made.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.