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

NCT06339528 | Completed

• 1 other identifier: EK-VPl421012021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Induced Vaginal Delivery

Keywords

Vojta's Reflex Locomotion; Induction of Labor; Delivery; Term pregnancy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

group stimulated according to the Vojta's Reflex Locomotion

EXPERIMENTAL

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

Procedure: Vojta's Reflex Locomotion

control group received a sham stimulation carried out by physicians

PLACEBO COMPARATOR

Control group received a sham stimulation carried out by physicians.

Procedure: Sham stimulation

Interventions

Vojta's Reflex Locomotion 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.

Also known as: Vojta's method, Vojta's therapy

group stimulated according to the Vojta's Reflex Locomotion

Sham stimulation 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.

control group received a sham stimulation carried out by physicians

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• pathological pregnancy
• cervix score less then 6

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, 11000, Czechia

Location

Related Publications (1)

• Milan M, Jan Z, Vit D, Nikola J, Barbora S, Anna B, Radovan V, Lukas R, Michael HJ, Tereza N. Safety of Vojta's reflex locomotion in term pregnancy: a randomized controlled pilot study of uterine activity and labor onset. Sci Rep. 2026 Jan 15;16(1):2095. doi: 10.1038/s41598-025-31871-9.

  PMID: 41540080 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Department of Obstetrics and Gynecology

Model Details: A total of 40 pregnant patients between 40+0 to 41+0 weeks of gestational age were randomly selected for this study. 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.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: June 23, 2021
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)