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临床试验/NCT05481983
NCT05481983Enrolling By Invitation不适用

the Effect of Clinical Exercise Training on Foot Plantar Pressure, Subtalar Joint and Gait Patterns in Pregnancy

Ege University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
104
试验地点
1
主要终点
Foot plantar pressure

研究概览

简要总结

The research will be conducted with healthy pregnant women who applied to the Ege University Gynecology and Obstetrics Department Polyclinic, and were referred to the Sports Medicine Department.The study will consist of two groups as the control group and the exercise group.Voluntary pregnant women who are not found to be inconvenient to do moderate-intensity exercise by the doctor will participate in the study.The study was planned as a randomized controlled and single-blind study.The participant's demographic information, obstetric assessment, physical activity level, fall history and pain assessment will be recorded.Foot plantar pressure, static and dynamic balance, center of pressure (COP), subtalar joint evaluation and gait evaluation will be measured by pedobarography at Ege University Orthopedics and Traumatology Department Gait Laboratory.The control group will be offered walking as recommended by ACOG for pregnant women.Clinical exercise training will be given to pregnant women in the study group by a specialist physiotherapist.

详细描述

Pregnancy is a condition that includes many parameters.As the gestational week progresses and the fetus grows, changes are observed in the musculoskeletal system, hormonal system and other systems of the mother's body.Mechanical pain is observed in pregnant women with the expansion of the pelvis and the increase in the load on the lower extremities.The American Society of Obstetrics and Gynecology (ACOG) recommends physical activity and moderate-intensity exercises for a healthy pregnancy and delivery in pregnant women.Foot plantar pressure measurement is accepted in the literature as an objective measurement method in lower extremity biomechanical pain, static and dynamic balance.Evaluations will be made on day 0 and the day corresponding to the end of the 8th week.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

The Randomization algorithm (Maximum Allowed % Deviation = 10%) was applied using PASS software 11.0 (NCSS LLC, Kaysville, UT) to generate a randomization list that would assign participants to two groups of 52 each.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being between the ages of 18-40
  • No risk of pregnancy-related complications
  • Between 12th and 24th weeks of pregnancy

排除标准

  • History of lower extremity, pelvis or spine surgery
  • Pain in the lower extremity, pelvis, and spine that persists for more than 6 months
  • Any developmental delay related to the fetus

结局指标

主要结局

Foot plantar pressure

时间窗: 8 weeks

A change in gait pattern will be observed with pregnancy

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

AYŞE KAYALI VATANSEVER

Physiotherapist, MSc.

Ege University

研究点 (1)

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