Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment
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ClinicalTrials.gov Identifier: NCT05190029 |
Recruitment Status :
Completed
First Posted : January 13, 2022
Last Update Posted : February 8, 2022
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Tracking Information | |||||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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:
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. |
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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 |
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Condition ICMJE | Child Development Disorder | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Complete sample
Group of 120 children evaluated by craniosacral therapy for cranial blocks and primitive reflexes.
Interventions:
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | GEMA LEÓN BRAVO, Clinica Gema Leon | ||||||
Study Sponsor ICMJE | Clinica Gema Leon | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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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 |