Persisting Primitive ReflexesNCT06071000
Preschool Children Motor Development
A study testing Neuro-developmental stimulation (Neuro-vývojová stimulace). in people with Persisting Primitive Reflexes, run by Charles University, Czech Republic.
Trial summary
The preschool age period is crucial for motor and cognitive development, which retention primary reflexes can negatively influence. Primary reflexes are fixed motor patterns controlled from developmentally lower areas of CNS and are necessary for delivery, survival or rudimentary movement activation during infancy and… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Persisting Primitive Reflexes
- What is being tested?
- Neuro-developmental stimulation (Neuro-vývojová stimulace).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 30 Sep 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy
Who cannot join
- strong ADHD/learning disorders diagnosed
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Neurodevelopmental Stimulation on Motor and Cognitive Development in Neurotypical Healthy Children
The preschool age period is crucial for motor and cognitive development, which retention primary reflexes can negatively influence. Primary reflexes are fixed motor patterns controlled from developmentally lower areas of CNS and are necessary for delivery, survival or rudimentary movement activation during infancy and should be progressively inhibited. Primary reflexes' retention increases the risk of blocks for further cognitive and motor development in higher, mainly cortical areas. Children in preschool and school age with non-inhibited primary reflexes displayed a poor level of fundamental movement skills and worse attention, self-regulation or working memory capacity. Children with the problems above usually pass a movement program based on developmental kinesiology, like Neurodevelopmental stimulation (NVS). NVS contains exercises that simulate situations for adequate processing of the primary reflex and allow the brain to correct and inhibit this reflex. Even though in the Czech preschool environment, almost 13% of children with neurotypical development have significant positive responses to at least one primary reflex, there are no methods to inhibit primary reflexes to improve motor and cognitive development positively. Therefore, this project aims to find how the NVS intervention will influence the performance in the selected area of motor and cognitive development, with the follow-up three-month retesting. Population for this project are preschool children aged 4-6 years old.
- Conditions
- Persisting Primitive Reflexes
- Being tested
- Neuro-developmental stimulation (Neuro-vývojová stimulace).
- Keywords
- motor development, fundamental motor skills, executive functions, neurodevelopmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-developmental stimulation (Neuro-vývojová stimulace).Behavioural
Neuro-developmental stimulation is exercise based intervention program that is focused on repeating reflex movements and thus inhibiting reflexive response.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Behavioral: Neuro-developmental stimulation (Neuro-vývojová stimulace). |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
TGMD-2
Test of gross motor development
Measured: 8 months
IDS / IDS-P
Intelligence and Development Scale (preschool)
Measured: 8 months
Primitive (primary) reflexes
Tests for persisting (retained) primitive reflexes
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persisting Primitive ReflexesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071000
- Sponsor's protocol ID
- Motor development - Adam
- Status last verified
- Jan 2023
- First submitted
- 21 Jul 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurodevelopmental Stimulation on Motor and Cognitive Development in Neurotypical Healthy Children
- ClinicalTrials.gov ID
- NCT06071000
- Acronym / sponsor ID
- Motor development - Adam
- Conditions
- Persisting Primitive Reflexes
- Keywords
- motor development, fundamental motor skills, executive functions, neurodevelopmental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 6 Oct 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.
The preschool age period is crucial for motor and cognitive development, which retention primary reflexes can negatively influence. Primary reflexes are fixed motor patterns controlled from developmentally lower areas of CNS and are necessary for delivery, survival or rudimentary movement activation during infancy and should be progressively inhibited. Primary reflexes' retention increases the risk of blocks for further cognitive and motor development in higher, mainly cortical areas. Children in preschool and school age with non-inhibited primary reflexes displayed a poor level of fundamental movement skills and worse attention, self-regulation or working memory capacity. Children with the problems above usually pass a movement program based on developmental kinesiology, like Neurodevelopmental stimulation (NVS). NVS contains exercises that simulate situations for adequate processing of the primary reflex and allow the brain to correct and inhibit this reflex. Even though in the Czech preschool environment, almost 13% of children with neurotypical development have significant positive responses to at least one primary reflex, there are no methods to inhibit primary reflexes to improve motor and cognitive development positively. Therefore, this project aims to find how the NVS intervention will influence the performance in the selected area of motor and cognitive development, with the follow-up three-month retesting. Population for this project are preschool children aged 4-6 years old.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Neuro-developmental stimulation (Neuro-vývojová stimulace). |
| Control group | No intervention | – |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (1 listed)
- strong ADHD/learning disorders diagnosed
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 |
|---|---|---|
| Neuro-developmental stimulation (Neuro-vývojová stimulace).Neuro-developmental stimulation is exercise based intervention program that is focused on repeating reflex movements and thus inhibiting reflexive response. | Behavioural | Experimental group |
Primary outcome
TGMD-2
Time frame: 8 months
Test of gross motor development
IDS / IDS-P
Time frame: 8 months
Intelligence and Development Scale (preschool)
Primitive (primary) reflexes
Time frame: 8 months
Tests for persisting (retained) primitive reflexes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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 Neuro-developmental stimulation (Neuro-vývojová stimulace). in people with Persisting Primitive Reflexes, run by Charles University, Czech Republic.
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 6 Oct 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 Adam Provazník (774138660, pro.vaz.nik@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TGMD-2 (time frame: 8 months). The study lists 3 primary outcomes in all. 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 6 Oct 2023.