Clinical trial NCT05190029: Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment
Official title: Early Craniosacral and Primitive Reflex Assessment in Infant Neurodevelopment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development Disorder
Keywords: primitive reflexes
craniosacral disfunctions
neurodevelopment
childhood
early diagnosis
screening
Lead sponsor: Clinica Gema Leon
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 120 children aged 3 to 8 years from a school in Córdoba (Spain). Subjects of both sexes were included and were divided into two groups according to age ranges: 3 to 6 years and 6 to 8 years.
Primary purpose: DIAGNOSTIC

Brief summary: Question(s): Can active primitive reflexes (APR) and cranial blocks (CB) in healthy children interfere with neurological balance causing psycho-behavioral and cognitive dysfunctions? Design: Cross-sectional and descriptive study analyzing perinatal, neurobehavioral and physiotherapeutic parameters. Participants: School population of both genders (n=120) divided in two groups: 3-6 years old (n=60) and 6-8 years old (n=60). Intervention: Systematic evaluation of the children based on a parent survey, assessment by teachers and physiotherapeutic exploration. Outcome measures: Perinatal (surveyed parents) and neurobehavioral problems (assessed by teachers) were related to the presence of RPA and BC (analyzed by physiotherapeutic exploration).

Key words: primitive reflexes, craniosacral disfunctions, neurodevelopment, childhood, early diagnosis, screening.

Detailed description: Primitive reflexes (PR) are indispensable for the survival of the individual in the early stages of life. PR are necessary for a coordinated response to sensory stimuli during the period of cortical immaturity until the maturation of the central nervous system (CNS). However, PR must be gradually abolished as the subject's development proceeds, allowing for voluntary and functional movement responses. This process of PR abolition is due to the synaptic plasticity of the CNS. Persistent ROP can be identified by means of a systematic neurological examination. On the other hand, through craniosacral exploration, blockages in the craniosacral system can be evidenced; under physiological conditions, this system seeks to balance the mobility of membranes and cranial sutures, based on the coordinated movement of the cranial bones and the sacrum. If neurological homeostasis is disturbed in the child after diagnosing possible BC, this could manifest in the persistence of RPA and/or vice versa.

Observation of the child's different behavioral patterns in social and emotional areas, as well as his or her physical and psychological capacities, could help to detect early possible alterations in the onset of neurodevelopment. Such detection is essential for the health professional to be able to establish an appropriate treatment.

The aim of this study is to detect early infant neurodevelopmental dysfunctions and their possible relationship with RPA and/or BC in apparently healthy children.

Therefore, the research questions of this study were:

1. Are RPA and/or BC related to child neurodevelopmental disturbances?
2. In relation to the previous question, by means of the systematic evaluation of RPA and BC could children with neurodevelopmental disorders be identified in order to treat them early?

Design A cross-sectional, observational and descriptive study was conducted in a school population.

Participants, therapists, centers A total of 120 children between 3 and 8 years of age from a school in Córdoba (Spain) were evaluated. Subjects of both sexes were included and were divided into two groups according to age ranges: 3 to 6 years and 6 to 8 years. The neurodevelopmental assessment was made taking into account the growth stages standardized by the WHO.

Prior approval was obtained from the Research Ethics Committee of Córdoba for the present study. The harmonized tripartite standards of the Helsinki declaration, the Biomedical Research Law (Law 14/2007), and the Organic Law on Personal Data Protection (Organic Law 3/2018) were respected at all times. The application of tests and data collection for the research was performed within the facilities of the educational institution, with the collaboration of the teachers and having the due authorization of the academic director and the parents or legal representatives of the students.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy children
* School group
* Within age range

Exclusion Criteria:

* Children with possible pathologies
* Older than the established age

Primary outcomes:
measure: Series of questions to the children's parents
timeFrame: one week
measure: Teachers' test by means of the "Battelle Development Inventory" (BDI).
timeFrame: Three weeks
Secondary outcomes:
measure: Craniosacral evaluation of possible cranial blocks
timeFrame: Three weeks
measure: Craniosacral evaluation of active primitive reflexes.
timeFrame: Three weeks
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Clinica de Fisioterapia Gema León
state: Andalucía
Study officials:
affiliation: Universidad de Córdoba
name: Irene Cantarero, Study Chair
role: STUDY_CHAIR
affiliation: Universidad de Córdoba
name: Javier Caballero Villarraso, Study Direct
role: STUDY_DIRECTOR
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