Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06339528 |
Other study ID # |
EK-VPl421012021 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 23, 2021 |
Est. completion date |
March 1, 2024 |
Study information
Verified date |
April 2024 |
Source |
Faculty Hospital Kralovske Vinohrady |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.