Abdominal MusclesNCT06159426
Expert vs. Non-expert Abdominal Electromyographic Control in Vojta Therapy
A study testing Vojta Therapy in people with Abdominal Muscles, run by University of Salamanca.
Trial summary
Randomized clinical trial on a cohort of healthy subjects of legal age, of both sexes, recruited from the university community and who will be randomly distributed into two groups (expert therapist vs. non-expert therapist). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Muscles
- What is being tested?
- Vojta Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2023to 1 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- Full cognitive capacity.
Who cannot join
- Subjects with neuro-muscular pathologies that affect the abdominal muscles, previous surgeries in the area or any chronic neurological or organic disorder that may alter the results.
- Vaccinated in the 10 days prior to the intervention
- Fever
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Electromyographic Response Control in the Application of Vojta Therapy in the Abdominal Muscles of Healthy Young Adults: Expert vs Non-expert Comparison
Randomized clinical trial on a cohort of healthy subjects of legal age, of both sexes, recruited from the university community and who will be randomly distributed into two groups (expert therapist vs. non-expert therapist). The objective will be to determine if there are differences in the muscular activation produced on the stabilizing muscles of the trunk (external oblique and internal oblique) if it is applied by an expert therapist versus if it is applied by a therapist not specialized in therapy and to know the effects produced on the muscles studied after performing the intervention.
- Conditions
- Abdominal Muscles
- Being tested
- Vojta Therapy
- Keywords
- Electromyography, Muscle Contraction, Expert Therapist, Outcome and Process Assessment, Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta TherapyOther
The subject will be placed on a stretcher with the torso uncovered. Once the adhesive electrodes have been placed in the different recording areas on the anterior part of the trunk, a recording of the activity at rest will begin, two minutes of stimulation (digital pressure), one minute of rest, two minutes of stimulation in the contralateral side and, finally, one minute of rest.
The therapy consists of the application of a stimulating pressure in the pectoral area in the pattern of the locomotion complex of reflex rolling in its first phase. For this, the subject will be placed in a supine position aligned with respect to the axial axis, with the arms along the body, the lower extremities in extension, and the head extended with a rotation of approximately 30º towards one side of the stimulation. The manual stimulation pressure will be exerted in the space between the 6th-7th or the 7th-8th rib under the mammillary line, with a force of about 2 kg.
| Study group | Role | What they receive |
|---|---|---|
| Expert group | Experimental | The stimulation will be applied by an expert therapist. Receives: Other: Vojta Therapy |
| Non-expert group | Active comparator | This group will receive the same stimulation as the expert group but in this case it will be applied by a therapist not specialized in therapy. Receives: Other: Vojta Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic activity in abdominal muscles
The electromyographic activity of internal and external obliques in nanovolts will be collected before, during and after the intervention.
Measured: Change from Baseline electromyographic activity at 7 minutes.
Secondary outcomes (4)
Date of birth
It will be registered at the beginning of the study in order to calculate the age of the participant.
Measured: Baseline
Sex
It will be registered at the beginning of the study.
Measured: Baseline
Height
It will be registered at the beginning of the study in centimeters.
Measured: Baseline
Weight
It will be registered at the beginning of the study in kilograms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start10 Dec 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal MusclesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Luis Sanchez Gonzalez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159426
- Sponsor's protocol ID
- NEUROUSAL04/2023
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Response Control in the Application of Vojta Therapy in the Abdominal Muscles of Healthy Young Adults: Expert vs Non-expert Comparison
- ClinicalTrials.gov ID
- NCT06159426
- Acronym / sponsor ID
- NEUROUSAL04/2023
- Conditions
- Abdominal Muscles
- Keywords
- Electromyography, Muscle Contraction, Expert Therapist, Outcome and Process Assessment, Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 10 Dec 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
Randomized clinical trial on a cohort of healthy subjects of legal age, of both sexes, recruited from the university community and who will be randomly distributed into two groups (expert therapist vs. non-expert therapist). The objective will be to determine if there are differences in the muscular activation produced on the stabilizing muscles of the trunk (external oblique and internal oblique) if it is applied by an expert therapist versus if it is applied by a therapist not specialized in therapy and to know the effects produced on the muscles studied after performing the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expert group | Experimental | Other: Vojta TherapyThe stimulation will be applied by an expert therapist. |
| Non-expert group | Active comparator | Other: Vojta TherapyThis group will receive the same stimulation as the expert group but in this case it will be applied by a therapist not specialized in therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years old.
- Full cognitive capacity.
Key exclusion criteria (3 listed)
- Subjects with neuro-muscular pathologies that affect the abdominal muscles, previous surgeries in the area or any chronic neurological or organic disorder that may alter the results.
- Vaccinated in the 10 days prior to the intervention
- Fever
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 TherapyThe subject will be placed on a stretcher with the torso uncovered. Once the adhesive electrodes have been placed in the different recording areas on the anterior part of the trunk, a recording of the activity at rest will begin, two minutes of stimulation (digital pressure), one minute of rest, two minutes of stimulation in the contralateral side and, finally, one minute of rest. The therapy consists of the application of a stimulating pressure in the pectoral area in the pattern of the locomotion complex of reflex rolling in its first phase. For this, the subject will be placed in a supine position aligned with respect to the axial axis, with the arms along the body, the lower extremities in extension, and the head extended with a rotation of approximately 30º towards one side of the stimulation. The manual stimulation pressure will be exerted in the space between the 6th-7th or the 7th-8th rib under the mammillary line, with a force of about 2 kg. | Other | Expert group, Non-expert group |
Primary outcome
Electromyographic activity in abdominal muscles
Time frame: Change from Baseline electromyographic activity at 7 minutes.
The electromyographic activity of internal and external obliques in nanovolts will be collected before, during and after the intervention.
4 secondary outcomes
Date of birth
Time frame: Baseline
Sex
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta Therapy in people with Abdominal Muscles, run by University of Salamanca.
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 2 inclusion and 3 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 14 Dec 2023. 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. 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?
Contact Juan Luis Sánchez González, PhD (+34 660 738 949, juanluissanchez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyographic activity in abdominal muscles (time frame: Change from Baseline electromyographic activity at 7 minutes.). 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 14 Dec 2023.