Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 16 for:    Parachute
Previous Study | Return to List | Next Study

Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05190029
Recruitment Status : Completed
First Posted : January 13, 2022
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
GEMA LEÓN BRAVO, Clinica Gema Leon

Tracking Information
First Submitted Date  ICMJE December 15, 2021
First Posted Date  ICMJE January 13, 2022
Last Update Posted Date February 8, 2022
Actual Study Start Date  ICMJE December 1, 2021
Actual Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2022)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2022)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment
Official Title  ICMJE Early Craniosacral and Primitive Reflex Assessment in Infant Neurodevelopment.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Child Development Disorder
Intervention  ICMJE
  • 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).
Study Arms  ICMJE Experimental: Complete sample
Group of 120 children evaluated by craniosacral therapy for cranial blocks and primitive reflexes.
Interventions:
  • Diagnostic Test: Series of questions to parents of children in a virtual form.
  • Other: Intervention by teachers
  • Procedure: Physiotherapeutic evaluation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2022)		 120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 5, 2022
Actual Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Apparently healthy children
  • School group
  • Within age range

Exclusion Criteria:

  • Children with possible pathologies
  • Older than the established age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05190029
Other Study ID Numbers  ICMJE ART-GLB-PRIMITIVE REFLEXES
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The request for data will be studied and considered upon justified request.
Responsible Party GEMA LEÓN BRAVO, Clinica Gema Leon
Study Sponsor  ICMJE Clinica Gema Leon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Irene Cantarero, Study Chair Universidad de Córdoba
Study Director: Javier Caballero Villarraso, Study Direct Universidad de Córdoba
PRS Account Clinica Gema Leon
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP