- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07152262
- Original Trial
Effects of Menstrual Cycle Phases on Gait, Pelvis, and Sleep
Investigation of the Effects of Menstrual Cycle Phases on Spatiotemporal Characteristics of Gait, Pelvic Kinematics, and Sleep Quality
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye)
- Yüksek İhtisas University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Gait Speed Across Menstrual Phases
Time Frame: Within one menstrual cycle (~3-4 weeks).
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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).
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Within one menstrual cycle (~3-4 weeks).
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Change in Cadence Across Menstrual Phases
Time Frame: Within one menstrual cycle (~3-4 weeks).
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Within-subject change in step cadence( steps/min) recorded by BTS-G walk across the same three phases.
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Within one menstrual cycle (~3-4 weeks).
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Change in Stride Length Across Menstrual Phases
Time Frame: Within one menstrual cycle (~3-4 weeks).
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Within-subject change in stride length (centimeters/cm) captured by BTS-G walk across the three phases.
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Within one menstrual cycle (~3-4 weeks).
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Change in Stance and Swing Phase Percentages
Time Frame: Within one menstrual cycle (~3-4 weeks).
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Within-subject change in stance (%) and swing (%) durations during gait across phases using BTS-G walk.
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Within one menstrual cycle (~3-4 weeks).
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Change in Pelvic Kinematics
Time Frame: Within one menstrual cycle (~3-4 weeks).
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Within-subject change in pelvic tilt (degree), obliquity (degree), and rotation symmetry (degree) indices obtained from BTS-G walk across phases.
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Within one menstrual cycle (~3-4 weeks).
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Change in Sleep Quality
Time Frame: Within one menstrual cycle (~3-4 weeks).
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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.
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Within one menstrual cycle (~3-4 weeks).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gungor Beyza Ozvar Senoz, Yüksek İhtisas University
- Study Director: Busra Kalkan Balak, Yüksek İhtisas University
- Principal Investigator: Aylin Baykal, Yüksek İhtisas University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Menstrual Cycle
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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