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Completed

NCT Number: NCT05190029

Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment

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.

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica de Fisioterapia Gema León

Córdoba, Andalusia, 14011, Spain

About this study

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:

  • Are RPA and/or BC related to child neurodevelopmental disturbances?
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Apparently healthy children
  • School group
  • Within age range

Exclusion criteria

  • Children with possible pathologies
  • Older than the established age

Treatment and study plan

Series of questions to parents of children in a virtual form.

Diagnostic Test

A questionnaire of 5 questions was provided in an online format addressed to the parents or legal representatives of each child. These questions were related to the child's own aspects (behavioral, psychomotor and cognitive parameters), as well as parameters oriented to the mother (pregnancy and childbirth).

Intervention by teachers

Other

The school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which assesses five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-50%), normal (50-80%) and high (80-100%). Low and high values are considered impairments in one or more of the evaluated areas.

Physiotherapeutic evaluation

Procedure

A physiotherapeutic evaluation of the state of the RP and craniosacral system was performed according to the method of Andrzej Pilat and John E. Upledger.

The 14 primitive reflexes explored were: Moro reflex, cervical asymmetric, supine labyrinthine tonic, prone labyrinthine tonic, palmar grasp, plantar grasp, lateral trunk propulsion, parachute, Galant, search, cervical symmetric, Babinski, cochleo-palpebral and acoustic. These reflexes were considered as: inactive (0), or active (1).

In the evaluation of the craniosacral system, the following parameters were explored: dura mater sway, frontal bone, parietal bones, temporal bones, temporomandibular joint and sphenoid bone. These parameters were considered as: normal (0), or blockage (1).

Primary outcomes

  1. Series of questions to the children's parents

    Time frame: one week

    A questionnaire of 5 questions in an online format was sent to the parents or legal representatives of each child related to behavioral, psychomotor and cognitive aspects, pregnancy and childbirth.

  2. Teachers' test by means of the "Battelle Development Inventory" (BDI).

    Time frame: Three weeks

    The school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which assesses five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-50%), normal (50-80%) and high (80-100%). Low and high values are considered impairments in one or more of the evaluated areas.

Secondary outcomes

  1. Craniosacral evaluation of possible cranial blocks

    Time frame: Three weeks

    In the evaluation of the craniosacral system, the following parameters were explored: dura mater sway, frontal bone, parietal bones, temporal bones, temporomandibular joint and sphenoid bone. These parameters were considered as: normal (0), or blockage (1).

  2. Craniosacral evaluation of active primitive reflexes.

    Time frame: Three weeks

    14 primitive reflexes explored were: Moro reflex, cervical asymmetric, supine labyrinthine tonic, prone labyrinthine tonic, palmar prehension, plantar prehension, lateral trunk propulsion, parachute, Galant, search, cervical symmetric, Babinski, cochleo-palpebral and acoustic. These reflexes were considered as: inactive (0), or active (1).

Sponsors and collaborators

Lead sponsor

Clinica Gema Leon

Other

Registry information

Official study title

Early Craniosacral and Primitive Reflex Assessment in Infant Neurodevelopment.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 13, 2022
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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