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

NCT ID: NCT06339528

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2024-03-01

Brief Summary

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.

Detailed Description

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.

Several contraindications to the use of VRL should be considered when planning the treatment. Some of the main contraindications include: acute inflammation or infection, severe cardiovascular disease, acute joint or muscle pain or injury, severe neurological diseases, acute respiratory, and pregnancy for the risk of inducing uterine activity.

In obstetrics the two primary methods of inducing labor are pharmacological and non- pharmacological. The most commonly used non-pharmacological methods include cervical ripening using a balloon catheter with membrane sweeping efficient at 20% of patients or amniotomy, which can reduce duration of labor by approximately 2 hours.

This study aims to investigate the potential of VRL in initiating uterine activity and explore its feasibility as a new pre/induction method.

Conditions

Induced Vaginal Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

group stimulated according to the Vojta's Reflex Locomotion

Stimulation of trigger zones according to Vojta was applied to 20 of them by a team of licensed physiotherapists.

Group Type: EXPERIMENTAL

Vojta's Reflex Locomotion

Intervention Type: PROCEDURE

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. They are pressure stimulated in order to induce reflex response. 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.

control group received a sham stimulation carried out by physicians

Control group received a sham stimulation carried out by physicians.

Group Type: PLACEBO_COMPARATOR

Sham stimulation

Intervention Type: PROCEDURE

Control group received sham stimulation by physicians at zones outside of the pressure zones, specifically 4-5 cm above the patella and on the lateral malleolus.

Interventions

Vojta's Reflex Locomotion

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. They are pressure stimulated in order to induce reflex response. 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.

Intervention Type: PROCEDURE

Sham stimulation

Control group received sham stimulation by physicians at zones outside of the pressure zones, specifically 4-5 cm above the patella and on the lateral malleolus.

Intervention Type: PROCEDURE

Other Intervention Names

Vojta's method; Vojta's therapy

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• pathological pregnancy
• cervix score less then 6

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jan Zapletal

Medical Doctor, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

Countries

Czechia

Other Identifiers

EK-VPl421012021

Identifier Type: -

Identifier Source: org_study_id