Gait, FrontalV&GNCT04689841
Influence of Short-term Vojta Therapy on the Gait in Healthy Adult Subjects.
A study testing Vojta Therapy in people with Gait, Frontal, run by NUMEN Foundation.
Trial summary
The patterns of reflex locomotion described by Vojta contain all the basic patterns necessary for gait, which can be observed as partial patterns during normal postural ontogenesis in the first year of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait, Frontal
- What is being tested?
- Vojta Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2021to 15 May 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be over 18 years old.
Who cannot join
- Present limitations or permanent or temporary injuries to the locomotor system.
About this study
The patterns of reflex locomotion described by Vojta contain all the basic patterns necessary for gait, which can be observed as partial patterns during normal postural ontogenesis in the first year of life. These patterns are triggered throughout life regardless of age, so they can be activated both in healthy subjects and in the presence of neurological pathology in adult patients.
Read the detailed description
In reflex locomotion, there is a coordinated and rhythmic activation of the entire skeletal muscles and different circuits of the central nervous system are stimulated. The motor reactions that are triggered regularly and cyclically due to pressure stimuli, from certain starting positions, are completely reproducible and as often as desired, even in the newborn child.
All the movements that appear in the development of the human being in grasping, turning, crawling, standing up and walking, are therefore visibly stimulated. They are, according to Prof. Vojta, present even in children of a developmental stage, in which they do not spontaneously yet possess these capacities.
Through the therapeutic application of reflex locomotion, those muscular functions used unconsciously and necessary for spontaneous daily motor skills are activated in the patient, especially in the spine, but also in the arms and legs, hands and feet and in the face.
- Conditions
- Gait, Frontal
- Being tested
- Vojta Therapy, placebo
- Keywords
- gait, Reflex Locomotion, Core stability, Ontogenesis, Neurorehabilitation, Neurological Disorder
- Medical subject headings
- Gait Disorders, Neurologic, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta TherapyOther
Also called Reflex Locomotion
Reflex locomotion is activated by the "reflexogenic" pathway. In context with reflex locomotion, the term "reflex" does not represent the mode of neuronal control, but rather refers to defined, "automatic" and always equal motor responses produced by external stimuli, applied therapeutically.
placeboOther
In the control group, a placebo intervention is administered, similar to an experimental intervention
| Study group | Role | What they receive |
|---|---|---|
| Vojta Therapy | Experimental | In Vojta therapy, the therapist selectively presses certain areas of the body, with the patient lying prone, - supine or - lateral. These types of stimuli, in humans of any age, provoke automatically and without their own initiative, that is, without the active voluntary collaboration of the person Receives: Other: Vojta Therapy |
| Control Group | Placebo comparator | In the control group, a placebo intervention is administered, similar to an experimental intervention Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes walk
walk for 6 minutes measuring the meters walked
Measured: one month
EMG surface
surface electromyography in four muscles
Measured: two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start25 Sep 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion15 May 2022 (estimated)
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 Gait, FrontalStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NUMEN Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689841
- Sponsor's protocol ID
- Numen2
- Acronym
- V&G
- Status last verified
- Aug 2021
- First submitted
- 28 Dec 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perales-Lopez L, Sanz-Esteban I, Jimenez-Antona C, Serrano JI, San-Martin-Gomez A, Vives-Gelabert X, Cano-de-la-Cuerda R. Automatic gait evoking in healthy adults through Vojta's peripheric somatosensory stimulation: a double-blind randomized controlled trial. J Neuroeng Rehabil. 2024 Oct 1;21(1):174. doi: 10.1186/s12984-024-01470-2.
PubMed 39354570
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Short-term Vojta Therapy on the Gait in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT04689841
- Acronym / sponsor ID
- V&G / Numen2
- Conditions
- Gait, Frontal
- Keywords
- gait, Reflex Locomotion, Core stability, Ontogenesis, Neurorehabilitation, Neurological Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- NUMEN FoundationUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Study start
- 25 Sep 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 30 Dec 2020 (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 patterns of reflex locomotion described by Vojta contain all the basic patterns necessary for gait, which can be observed as partial patterns during normal postural ontogenesis in the first year of life. These patterns are triggered throughout life regardless of age, so they can be activated both in healthy subjects and in the presence of neurological pathology in adult patients.
Detailed description
In reflex locomotion, there is a coordinated and rhythmic activation of the entire skeletal muscles and different circuits of the central nervous system are stimulated. The motor reactions that are triggered regularly and cyclically due to pressure stimuli, from certain starting positions, are completely reproducible and as often as desired, even in the newborn child.
All the movements that appear in the development of the human being in grasping, turning, crawling, standing up and walking, are therefore visibly stimulated. They are, according to Prof. Vojta, present even in children of a developmental stage, in which they do not spontaneously yet possess these capacities.
Through the therapeutic application of reflex locomotion, those muscular functions used unconsciously and necessary for spontaneous daily motor skills are activated in the patient, especially in the spine, but also in the arms and legs, hands and feet and in the face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vojta Therapy | Experimental | Other: Vojta TherapyIn Vojta therapy, the therapist selectively presses certain areas of the body, with the patient lying prone, - supine or - lateral. These types of stimuli, in humans of any age, provoke automatically and without their own initiative, that is, without the active voluntary collaboration of the person |
| Control Group | Placebo comparator | Other: placeboIn the control group, a placebo intervention is administered, similar to an experimental intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be over 18 years old.
Key exclusion criteria (1 listed)
- Present limitations or permanent or temporary injuries to the locomotor system.
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 TherapyAlso: Reflex LocomotionReflex locomotion is activated by the "reflexogenic" pathway. In context with reflex locomotion, the term "reflex" does not represent the mode of neuronal control, but rather refers to defined, "automatic" and always equal motor responses produced by external stimuli, applied therapeutically. | Other | Vojta Therapy |
| placeboIn the control group, a placebo intervention is administered, similar to an experimental intervention | Other | Control Group |
Primary outcome
6 Minutes walk
Time frame: one month
walk for 6 minutes measuring the meters walked
EMG surface
Time frame: two month
surface electromyography in four muscles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 39354570Perales-Lopez L, Sanz-Esteban I, Jimenez-Antona C, Serrano JI, San-Martin-Gomez A, Vives-Gelabert X, Cano-de-la-Cuerda R. Automatic gait evoking in healthy adults through Vojta's peripheric somatosensory stimulation: a double-blind randomized controlled trial. J Neuroeng Rehabil. 2024 Oct 1;21(1):174. doi: 10.1186/s12984-024-01470-2.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta Therapy in people with Gait, Frontal, run by NUMEN Foundation.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
6 Minutes walk (time frame: one month). 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 NCT04689841, 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 26 Aug 2021.