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

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.

Study Overview

• Status: Completed
• Conditions: Induced Vaginal Delivery
• Intervention / Treatment: Procedure: Vojta's Reflex Locomotion; Procedure: Sham stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 11000
    • Faculty Hospital Královské Vinohrady

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; Other Names: Vojta's method; Vojta's therapy
Placebo Comparator: control group received a sham stimulation carried out by physicians; Control group received a sham stimulation carried out by physicians.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiotocographic (CTG) recordings -	. 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.	right before and immediately after stimulation
subjective perception during 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.	immediately after stimulation

Collaborators and Investigators

• Sponsor: Faculty Hospital Kralovske Vinohrady

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Delivery; Induction of Labor; Term pregnancy; Vojta's Reflex Locomotion
• Other Study ID Numbers: EK-VPl421012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No