跳至主要内容
临床试验/NCT06339528
NCT06339528已完成不适用

Potential of Vojta's Reflex Locomotion as a Pre/Induction Method for Uterine Activity: a Pilot Study

Faculty Hospital Kralovske Vinohrady2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Cardiotocographic (CTG) recordings -

研究概览

简要总结

The Vojta's method is neurophysiological rehabilitation method used to support and induce reflex responses of locomotor and vegetative system. It uses involuntary motor reaction of the body during pressure stimulation of so-called trigger zones. Pregnancy is currently considered a contraindication for using Vojta's therapy to potential risks of inducing regular uterine activity and risk of delivery. The aim of the study is to evaluate changes in uterine activity and also explore the possibility of using this method as a new approach for pre/induction of delivery.

详细描述

Reflex locomotion according to Vojta's therapy is a neurorehabilitative concept originally used for diagnostics and treatment of infants who were at risk of non-physiological psychomotor development, especially spastic cerebral palsy. This concept utilizes stimulation of specific zones described by Vojta to evoke global motor and non-motor response.

Trigger zones are specific body zones that are stimulated with pressure during reflex locomotion stimulation.

According to the author of Vojta's reflex locomotion (VRL) - Václav Vojta, there are 10 trigger zones on human body. These trigger zones are pressure stimulated in order to induce reflex response. On upper and lower extremities periosteum is stimulated by pressure stimulation of trigger zones. During pressure stimulation of trigger zones on trunk autochthone musculature is stimulated. By stimulation of trigger zones located on joints, ligaments and joint surfaces are stimulated. Vojta's method uses spatial and temporal summation of signals of stimulated trigger zones. Variations of stimulation of different trigger zones (spatial summation) causes multiplication of afferent impulses. Sufficiently long stimulation of trigger zones (temporal summation) induces isometric contraction in muscle groups described by Vojta.

Motor response to trigger zones stimulation is involuntary and it manifests as a symmetrical as well as asymmetrical movement of the limbs, trunk, neck and head. These movements are sorted into two main movement complexes - reflex creeping and reflex rolling.

There are several different indications that may be a reason for using VRL. Some of the main indications in children include: cerebral palsy, hypotonia, hypertonia, coordination disorders, scoliosis and spinal cord injury. In adults, VRL is used as a treatment in many diseases of musculoskeletal apparatus, e.g.: vertebrogenic disorders, condition after stroke, muscular disorders and others.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Stimulation of trigger zones according to Vojta's therapy was applied to 20 of them by a team of licensed physiotherapists while a control group received a sham stimulation carried out by physicians. Cardiotocographic (CTG) recordings were conducted right before and immediately after stimulation. CTG recordings were subsequently blindly evaluated by 2 independent obstetricians. Patients did not know if clinician have skills to stimulate properly according to the Vojta's Reflex Locomotion.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • term pregnancy between 40+0 and 41+0 weeks of gestational age
  • physiological evaluation of the pregnancy
  • cervix score of at least 6
  • signed written consent after a detailed explanation of the potentional benefits and risks associated with the simulation method.

排除标准

  • pathological pregnancy
  • cervix score less then 6

结局指标

主要结局

Cardiotocographic (CTG) recordings -

时间窗: right before and immediately after stimulation

. Standard parameters such as basal rate, presence of accelerations and decelerations and variability of recording were evaluated in the cardiography recording. The tocographic record evaluated the presence of uterine activity, its intensity and regularity. CTG recordings were subsequently evaluated by 2 independent obstetricians.

subjective perception during stimulation

时间窗: immediately after stimulation

Non validated questionnaires were distributed to all the participants asking about subjective perception of contractions, body movement, breathing, pleasantness and pain. A scale from 1 to 10 for perception was made where 1 meant that stimulation was very pleasant and 10 was extremely unpleasant.

次要结局

未报告次要终点

研究者

发起方
Faculty Hospital Kralovske Vinohrady
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jan Zapletal

Medical Doctor, Department of Obstetrics and Gynecology

Faculty Hospital Kralovske Vinohrady

研究点 (2)

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