Locomotion Disorder, NeurologicVojtaRLNCT06224491
Non Motoric Reactions in Vojta Reflex Locomotion
A study testing Reflex locomotion according to Vojta in people with Locomotion Disorder, Neurologic, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Monitoring of non-motor manifestations of reflex locomotion according to Professor Vojta in laboratory conditions on healthy woman probands. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Locomotion Disorder, Neurologic
- What is being tested?
- Reflex locomotion according to Vojta
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2023to 31 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- These will be healthy adult women. The expected number of participants is 20-30. To participate in the study, participants must agree to participate voluntarily.
Who cannot join
- Contraindications for participation include psychiatric illness, cancer, acute inflammatory diseases, and pregnancy. Persons with signs of acute illness or injury or in recovery from acute illness or injury will not be eligible for testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Stress and Anxiety Levels and Ratings of Accompanying Non-occupational Symptoms in Vojta's Comprehensive RL Response
Monitoring of non-motor manifestations of reflex locomotion according to Professor Vojta in laboratory conditions on healthy woman probands.
Read the detailed description
The accompanying non-local manifestations during a maximum of 20 minutes of pressure stimulation of the zones defined by the concept of Professor Vojta will be observed. We will also examine the possible correlation between the magnitude of the response to Vojta Reflex Locomotion (VRL) and the degree of stress and anxiety on the part of the study participants. Approximately 20-30 participants will take part in the research. Manual stimulation of defined zones will be performed by an experienced physiotherapist who has successfully completed a course in the Vojta method. A Trigno Wireless EMG System Delsys device will be used to measure electrical muscle activity. Kistler force plates and a pliance-x® sensing system pedobarography device will be used to measure changes in standing. The SP-10 Pocket Spirometer Gima and wireless ECG will be used to measure changes in breathing and circulation. In addition, the DASS-42 and POMS questionnaires will be used. The aim of the study is to clarify whether during manual pressure stimulation of the zones defined by the above concept there is a change in electrical muscle activity, specific activity of the autonomic nervous system and whether there is a different partial pressure distribution in standing after the stimulation. Last but not least, the aim of the study is also to determine a possible correlation between the response rate to VRL and the level of stress and anxiety on the part of the study participants. All probands will be familiarized with the experimental measurement procedure and will sign an informed consent form prior to the start of the experiment. Measurements will be taken in the kinesiology laboratory of Physiotherapy department.
- Conditions
- Locomotion Disorder, Neurologic
- Being tested
- Reflex locomotion according to Vojta
- Keywords
- reflex locomotion according to Vojta, stress
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflex locomotion according to VojtaOther
Also called Placebo tactile stimulation.
Tactile stimulation according to Vojta´s reflex locomotion
| Study group | Role | What they receive |
|---|---|---|
| Placebo tactile stimulation | Sham comparator | From a standardized starting position for 10 minutes tactile contact in the area outside the description of reflex zones in reflex locomotion according to Vojta. Receives: Other: Reflex locomotion according to Vojta |
| Reflex locomotion zone stimulation | Experimental | From a standardized starting position tactile stimulation in the area of the zone in reflex locomotion according to Vojta for 10 minutes . Receives: Other: Reflex locomotion according to Vojta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-motor responses during tactile stimulation in reflex locomotion according to Vojta
The Trigno Wireless EMG System Delsys will be used to measure electrical muscle activity. The SP-10 Pocket Spirometer Gima and wireless ECG will be used to measure changes in breathing and circulation. In addition, the DASS-42 and POMS questionnaires will be used.
Measured: 10 minutes tactile stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Sep 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locomotion Disorder, NeurologicStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- These are healthy adult women. The expected number of participants is 20-30. To participate in the study, participants must agree to participate voluntarily. Contraindications for participation include psychiatric illness, cancer, acute inflammatory diseases, and pregnancy. Persons with signs of acute illness or injury or in recovery from acute illness or injury will not be eligible for testing. Subjects who, like the investigators, are students at FTVS UK will be personally approached and selected by the principal investigators. No email or phone number contacts will be used.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tereza Nováková, Charles University, Czech Republic
- Investigators
- Zuzana Charvátová, PhD., Study chair, Faculty of Physical Education and Sport Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224491
- Sponsor's protocol ID
- 122111PRG
- Acronym
- VojtaRL
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the possibility to share raw anonymised data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Stress and Anxiety Levels and Ratings of Accompanying Non-occupational Symptoms in Vojta's Comprehensive RL Response
- ClinicalTrials.gov ID
- NCT06224491
- Acronym / sponsor ID
- VojtaRL / 122111PRG
- Conditions
- Locomotion Disorder, Neurologic
- Keywords
- reflex locomotion according to Vojta, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 25 Jan 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.
Monitoring of non-motor manifestations of reflex locomotion according to Professor Vojta in laboratory conditions on healthy woman probands.
Detailed description
The accompanying non-local manifestations during a maximum of 20 minutes of pressure stimulation of the zones defined by the concept of Professor Vojta will be observed. We will also examine the possible correlation between the magnitude of the response to Vojta Reflex Locomotion (VRL) and the degree of stress and anxiety on the part of the study participants. Approximately 20-30 participants will take part in the research. Manual stimulation of defined zones will be performed by an experienced physiotherapist who has successfully completed a course in the Vojta method. A Trigno Wireless EMG System Delsys device will be used to measure electrical muscle activity. Kistler force plates and a pliance-x® sensing system pedobarography device will be used to measure changes in standing. The SP-10 Pocket Spirometer Gima and wireless ECG will be used to measure changes in breathing and circulation. In addition, the DASS-42 and POMS questionnaires will be used. The aim of the study is to clarify whether during manual pressure stimulation of the zones defined by the above concept there is a change in electrical muscle activity, specific activity of the autonomic nervous system and whether there is a different partial pressure distribution in standing after the stimulation. Last but not least, the aim of the study is also to determine a possible correlation between the response rate to VRL and the level of stress and anxiety on the part of the study participants. All probands will be familiarized with the experimental measurement procedure and will sign an informed consent form prior to the start of the experiment. Measurements will be taken in the kinesiology laboratory of Physiotherapy department.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- These are healthy adult women. The expected number of participants is 20-30. To participate in the study, participants must agree to participate voluntarily. Contraindications for participation include psychiatric illness, cancer, acute inflammatory diseases, and pregnancy. Persons with signs of acute illness or injury or in recovery from acute illness or injury will not be eligible for testing. Subjects who, like the investigators, are students at FTVS UK will be personally approached and selected by the principal investigators. No email or phone number contacts will be used.
| Arm | Type | Receives |
|---|---|---|
| Placebo tactile stimulation | Sham comparator | Other: Reflex locomotion according to VojtaFrom a standardized starting position for 10 minutes tactile contact in the area outside the description of reflex zones in reflex locomotion according to Vojta. |
| Reflex locomotion zone stimulation | Experimental | Other: Reflex locomotion according to VojtaFrom a standardized starting position tactile stimulation in the area of the zone in reflex locomotion according to Vojta for 10 minutes . |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- These will be healthy adult women. The expected number of participants is 20-30. To participate in the study, participants must agree to participate voluntarily.
Key exclusion criteria (1 listed)
- Contraindications for participation include psychiatric illness, cancer, acute inflammatory diseases, and pregnancy. Persons with signs of acute illness or injury or in recovery from acute illness or injury will not be eligible for testing.
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 |
|---|---|---|
| Reflex locomotion according to VojtaAlso: Placebo tactile stimulation.Tactile stimulation according to Vojta´s reflex locomotion | Other | Placebo tactile stimulation, Reflex locomotion zone stimulation |
Primary outcome
Non-motor responses during tactile stimulation in reflex locomotion according to Vojta
Time frame: 10 minutes tactile stimulation
The Trigno Wireless EMG System Delsys will be used to measure electrical muscle activity. The SP-10 Pocket Spirometer Gima and wireless ECG will be used to measure changes in breathing and circulation. In addition, the DASS-42 and POMS questionnaires will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No. According to the possibility to share raw anonymised data.
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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.
Zuzana Charvátová, PhD. study chair
Faculty of Physical Education and Sport Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflex locomotion according to Vojta in people with Locomotion Disorder, Neurologic, run by Charles University, Czech Republic 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 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 25 Jan 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?
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?
Non-motor responses during tactile stimulation in reflex locomotion according to Vojta (time frame: 10 minutes tactile stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2024.