Menstrual CycleNCT07152262
Effects of Menstrual Cycle Phases on Gait, Pelvis, and Sleep
An observational study of Menstrual Cycle and Sleep, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of different phases of the menstrual cycle on gait spatiotemporal characteristics, pelvic kinematics, and sleep quality in healthy women aged 18-35 years with regular menstrual cycles. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Sleep, Gait
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Feb 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women aged 18-35 years with regular menstrual cycles (28 ± 7 days). Participants will be assessed during three phases of their menstrual cycle (early follicular, ovulation, and luteal) to examine changes in gait parameters, pelvic kinematics, and sleep quality.
Who may be able to join
- Female, aged 18-35 years
- Voluntarily agrees to participate and provides informed consent
- Regular menstrual cycle (28 ± 7 days)
- Able to comply with study assessments and procedures
Who cannot join
- History of surgery within the past 6 months
- Current or chronic low back pain
- Dysmenorrhea complaints
- Neurological or orthopedic disorders affecting gait or muscle strength
- Presence of spinal deformities
- Rheumatologic disease
- Climacteric or menopausal period
- Any condition that may affect gait, pelvic kinematics, or sleep quality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Menstrual Cycle Phases on Spatiotemporal Characteristics of Gait, Pelvic Kinematics, and Sleep Quality
This study aims to investigate the effects of different phases of the menstrual cycle on gait spatiotemporal characteristics, pelvic kinematics, and sleep quality in healthy women aged 18-35 years with regular menstrual cycles. Participants will be assessed in three phases of the cycle: early follicular (days 1-3), ovulation (days 7-9, confirmed by ovulation test), and luteal (days 20-23). Gait parameters and pelvic kinematics will be evaluated using the BTS-G walk sensor system, while sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). The study seeks to determine whether physiological and hormonal changes during menstrual phases lead to measurable differences in gait, pelvic motion, and sleep quality.
Read the detailed description
This cross-sectional, prospective observational study investigates the influence of menstrual cycle phases on gait spatiotemporal characteristics, pelvic kinematics, and sleep quality in healthy women aged 18-35 years with regular menstrual cycles (28 ± 7 days). Hormonal changes during the cycle may affect musculoskeletal performance, balance, and sleep quality, yet the extent of these effects on gait and pelvic motion has not been fully clarified.
Participants will be evaluated in three phases of their menstrual cycle:
Early follicular phase (days 1-3), determined by the onset of menstrual bleeding, Ovulation phase (days 7-9), confirmed by a salivary ovulation test, Luteal phase (days 20-23), approximately 6-8 days after ovulation. At each phase, gait spatiotemporal parameters (speed, cadence, stride length, stance and swing phases, gait cycle duration) and pelvic kinematics (tilt, obliquity, rotation symmetry) will be assessed using the BTS-G walk wireless sensor system. Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI).
- Conditions
- Menstrual Cycle, Sleep, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Women with Regular Menstrual Cycles | Women aged 18-35 years with regular menstrual cycles (28 ± 7 days), evaluated prospectively during early follicular, ovulation, and luteal phases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed Across Menstrual Phases
Within-subject change in comfortable gait speed (meters/second (m/s)) measured by BTS-G walk sensor in three phases: early follicular (days 1-3), ovulation (days 7-9; salivary test-confirmed), luteal (days 20-23).
Measured: Within one menstrual cycle (~3-4 weeks).
Change in Cadence Across Menstrual Phases
Within-subject change in step cadence( steps/min) recorded by BTS-G walk across the same three phases.
Measured: Within one menstrual cycle (~3-4 weeks).
Change in Stride Length Across Menstrual Phases
Within-subject change in stride length (centimeters/cm) captured by BTS-G walk across the three phases.
Measured: Within one menstrual cycle (~3-4 weeks).
Change in Stance and Swing Phase Percentages
Within-subject change in stance (%) and swing (%) durations during gait across phases using BTS-G walk.
Measured: Within one menstrual cycle (~3-4 weeks).
Change in Pelvic Kinematics
Within-subject change in pelvic tilt (degree), obliquity (degree), and rotation symmetry (degree) indices obtained from BTS-G walk across phases.
Measured: Within one menstrual cycle (~3-4 weeks).
Change in Sleep Quality
Within-subject change in Pittsburgh Sleep Quality Index (PSQI) global score across phases. The PSQI is scored between 0 and 21. Higher scores indicate poorer sleep quality.
Measured: Within one menstrual cycle (~3-4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Jun 2025
- Primary completion20 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Responsible party
- Principal investigator, Güngör Beyza ÖZVAR, Hacettepe University
- Investigators
- Aylin Baykal, Principal investigator, Yuksek Ihtisas UniversityBusra Kalkan Balak, Study director, Yuksek Ihtisas UniversityGungor Beyza Ozvar Senoz, Principal investigator, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152262
- Sponsor's protocol ID
- Menstrual Cycle
- Status last verified
- May 2026
- First submitted
- 26 Aug 2025
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Menstrual Cycle Phases on Spatiotemporal Characteristics of Gait, Pelvic Kinematics, and Sleep Quality
- ClinicalTrials.gov ID
- NCT07152262
- Acronym / sponsor ID
- Menstrual Cycle
- Conditions
- Menstrual Cycle, Sleep, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 3 Sep 2025 (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 study aims to investigate the effects of different phases of the menstrual cycle on gait spatiotemporal characteristics, pelvic kinematics, and sleep quality in healthy women aged 18-35 years with regular menstrual cycles. Participants will be assessed in three phases of the cycle: early follicular (days 1-3), ovulation (days 7-9, confirmed by ovulation test), and luteal (days 20-23). Gait parameters and pelvic kinematics will be evaluated using the BTS-G walk sensor system, while sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). The study seeks to determine whether physiological and hormonal changes during menstrual phases lead to measurable differences in gait, pelvic motion, and sleep quality.
Detailed description
This cross-sectional, prospective observational study investigates the influence of menstrual cycle phases on gait spatiotemporal characteristics, pelvic kinematics, and sleep quality in healthy women aged 18-35 years with regular menstrual cycles (28 ± 7 days). Hormonal changes during the cycle may affect musculoskeletal performance, balance, and sleep quality, yet the extent of these effects on gait and pelvic motion has not been fully clarified.
Participants will be evaluated in three phases of their menstrual cycle:
Early follicular phase (days 1-3), determined by the onset of menstrual bleeding, Ovulation phase (days 7-9), confirmed by a salivary ovulation test, Luteal phase (days 20-23), approximately 6-8 days after ovulation. At each phase, gait spatiotemporal parameters (speed, cadence, stride length, stance and swing phases, gait cycle duration) and pelvic kinematics (tilt, obliquity, rotation symmetry) will be assessed using the BTS-G walk wireless sensor system. Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Women with Regular Menstrual Cycles | – | –Women aged 18-35 years with regular menstrual cycles (28 ± 7 days), evaluated prospectively during early follicular, ovulation, and luteal phases. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women aged 18-35 years with regular menstrual cycles (28 ± 7 days). Participants will be assessed during three phases of their menstrual cycle (early follicular, ovulation, and luteal) to examine changes in gait parameters, pelvic kinematics, and sleep quality.
Key inclusion criteria (4 listed)
- Female, aged 18-35 years
- Voluntarily agrees to participate and provides informed consent
- Regular menstrual cycle (28 ± 7 days)
- Able to comply with study assessments and procedures
Key exclusion criteria (8 listed)
- History of surgery within the past 6 months
- Current or chronic low back pain
- Dysmenorrhea complaints
- Neurological or orthopedic disorders affecting gait or muscle strength
- Presence of spinal deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Gait Speed Across Menstrual Phases
Time frame: Within one menstrual cycle (~3-4 weeks).
Within-subject change in comfortable gait speed (meters/second (m/s)) measured by BTS-G walk sensor in three phases: early follicular (days 1-3), ovulation (days 7-9; salivary test-confirmed), luteal (days 20-23).
Change in Cadence Across Menstrual Phases
Time frame: Within one menstrual cycle (~3-4 weeks).
Within-subject change in step cadence( steps/min) recorded by BTS-G walk across the same three phases.
Change in Stride Length Across Menstrual Phases
Time frame: Within one menstrual cycle (~3-4 weeks).
Within-subject change in stride length (centimeters/cm) captured by BTS-G walk across the three phases.
Change in Stance and Swing Phase Percentages
Time frame: Within one menstrual cycle (~3-4 weeks).
Within-subject change in stance (%) and swing (%) durations during gait across phases using BTS-G walk.
Change in Pelvic Kinematics
Time frame: Within one menstrual cycle (~3-4 weeks).
Within-subject change in pelvic tilt (degree), obliquity (degree), and rotation symmetry (degree) indices obtained from BTS-G walk across phases.
Change in Sleep Quality
Time frame: Within one menstrual cycle (~3-4 weeks).
Within-subject change in Pittsburgh Sleep Quality Index (PSQI) global score across phases. The PSQI is scored between 0 and 21. Higher scores indicate poorer sleep quality.
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 22 May 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.
Aylin Baykal principal investigator
Yuksek Ihtisas University
Busra Kalkan Balak study director
Yuksek Ihtisas University
Gungor Beyza Ozvar Senoz principal investigator
Yuksek Ihtisas University
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 Menstrual Cycle and Sleep, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 8 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 22 May 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 Turkey (Türkiye). 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?
Change in Gait Speed Across Menstrual Phases (time frame: Within one menstrual cycle (~3-4 weeks).). 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 22 May 2026.