Induced Vaginal DeliveryNCT06339528
Potential of Vojta's Reflex Locomotion as a Pre/Induction Method for Uterine Activity: a Pilot Study
A study testing Vojta's Reflex Locomotion in people with Induced Vaginal Delivery, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Vaginal Delivery
- What is being tested?
- Vojta's Reflex Locomotion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 23 Jun 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- pathological pregnancy
- cervix score less then 6
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Being tested
- Vojta's Reflex Locomotion, Sham stimulation
- Keywords
- Vojta's Reflex Locomotion, Induction of Labor, Delivery, Term pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta's Reflex LocomotionProcedure or surgery
Also called Vojta's method, Vojta's therapy
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.
Sham stimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: immediately after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start23 Jun 2021
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induced Vaginal DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jan Zapletal, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339528
- Sponsor's protocol ID
- EK-VPl421012021
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41540080
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of Vojta's Reflex Locomotion as a Pre/Induction Method for Uterine Activity: a Pilot Study
- ClinicalTrials.gov ID
- NCT06339528
- Acronym / sponsor ID
- EK-VPl421012021
- Conditions
- Induced Vaginal Delivery
- Keywords
- Vojta's Reflex Locomotion, Induction of Labor, Delivery, Term pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| group stimulated according to the Vojta's Reflex Locomotion | Experimental | Procedure: Vojta's Reflex LocomotionStimulation of trigger zones according to Vojta was applied to 20 of them by a team of licensed physiotherapists. |
| control group received a sham stimulation carried out by physicians | Placebo comparator | Procedure: Sham stimulationControl group received a sham stimulation carried out by physicians. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- pathological pregnancy
- cervix score less then 6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vojta's Reflex LocomotionAlso: Vojta's method, Vojta's therapyReflex 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. | Procedure or surgery | group stimulated according to the Vojta's Reflex Locomotion |
| Sham stimulationControl 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. | Procedure or surgery | control group received a sham stimulation carried out by physicians |
Primary outcome
Cardiotocographic (CTG) recordings -
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 41540080Milan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta's Reflex Locomotion in people with Induced Vaginal Delivery, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiotocographic (CTG) recordings - (time frame: right before and immediately after stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06339528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.