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临床试验/NCT07152262
NCT07152262已完成不适用

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

Hacettepe University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in Gait Speed Across Menstrual Phases

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in Gait Speed Across Menstrual Phases

时间窗: 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

时间窗: 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 Pelvic Kinematics

时间窗: 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 Stride Length Across Menstrual Phases

时间窗: 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

时间窗: 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 Sleep Quality

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Güngör Beyza ÖZVAR

Principal Investigator

Hacettepe University

研究点 (2)

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