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NCT Number: NCT07152262

Effects of Menstrual Cycle Phases on Gait, Pelvis, and Sleep

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.

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Key information

Conditions

Menstrual Cycle Gait Sleep

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Yuksek Ihtisas University

Ankara, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Yuksek Ihtisas University

Registry information

Official study title

Investigation of the Effects of Menstrual Cycle Phases on Spatiotemporal Characteristics of Gait, Pelvic Kinematics, and Sleep Quality

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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