Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment

February 5, 2022 updated by: GEMA LEÓN BRAVO, Clinica Gema Leon

Early Craniosacral and Primitive Reflex Assessment 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Andalucía
      • Córdoba, Andalucía, Spain, 14011
        • Clinica de Fisioterapia Gema León

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Apparently healthy children
  • School group
  • Within age range

Exclusion Criteria:

  • Children with possible pathologies
  • Older than the established age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Complete sample
Group of 120 children evaluated by craniosacral therapy for cranial blocks and primitive reflexes.
Diagnostic test: Series of questions to parents of children in a virtual form.
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).
Other: Intervention by teachers
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.
Procedure: Physiotherapeutic evaluation

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one week
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.
Three weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Three weeks
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).
Three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Gema Leon

Investigators

  • Study Chair: Irene Cantarero, Study Chair, Universidad de Córdoba
  • Study Director: Javier Caballero Villarraso, Study Direct, Universidad de Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

February 5, 2022

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 5, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-GLB-PRIMITIVE REFLEXES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The request for data will be studied and considered upon justified request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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