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Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment

Primary Purpose

Child Development Disorder

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Series of questions to parents of children in a virtual form.
Intervention by teachers
Physiotherapeutic evaluation
Sponsored by
Clinica Gema Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Child Development Disorder focused on measuring primitive reflexes, craniosacral disfunctions, neurodevelopment, childhood, early diagnosis, screening

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Apparently healthy children
  • School group
  • Within age range

Exclusion Criteria:

  • Children with possible pathologies
  • Older than the established age

Sites / Locations

  • Clinica de Fisioterapia Gema León

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Complete sample

Arm Description

Group of 120 children evaluated by craniosacral therapy for cranial blocks and primitive reflexes.

Outcomes

Primary Outcome Measures

Series of questions to the children's parents
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).
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 Outcome Measures

Craniosacral evaluation of possible cranial blocks
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.
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).

Full Information

First Posted
December 15, 2021
Last Updated
February 5, 2022
Sponsor
Clinica Gema Leon
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1. Study Identification

Unique Protocol Identification Number
NCT05190029
Brief Title
Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment
Official Title
Early Craniosacral and Primitive Reflex Assessment in Infant Neurodevelopment.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
February 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Gema Leon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development Disorder
Keywords
primitive reflexes, craniosacral disfunctions, neurodevelopment, childhood, early diagnosis, screening

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complete sample
Arm Type
Experimental
Arm Description
Group of 120 children evaluated by craniosacral therapy for cranial blocks and primitive reflexes.
Intervention Type
Diagnostic Test
Intervention Name(s)
Series of questions to parents of children in a virtual form.
Intervention Description
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 Type
Other
Intervention Name(s)
Intervention by teachers
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapeutic evaluation
Intervention Description
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 Outcome Measure Information:
Title
Series of questions to the children's parents
Description
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.
Time Frame
one week
Title
Teachers' test by means of the "Battelle Development Inventory" (BDI).
Description
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.
Time Frame
Three weeks
Secondary Outcome Measure Information:
Title
Craniosacral evaluation of possible cranial blocks
Description
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).
Time Frame
Three weeks
Title
Craniosacral evaluation of active primitive reflexes.
Description
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).
Time Frame
Three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Apparently healthy children School group Within age range Exclusion Criteria: Children with possible pathologies Older than the established age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Cantarero, Study Chair
Organizational Affiliation
Universidad de Córdoba
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Javier Caballero Villarraso, Study Direct
Organizational Affiliation
Universidad de Córdoba
Official's Role
Study Director
Facility Information:
Facility Name
Clinica de Fisioterapia Gema León
City
Córdoba
State/Province
Andalucía
ZIP/Postal Code
14011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The request for data will be studied and considered upon justified request.
Citations:
PubMed Identifier
33172138
Citation
Pecuch A, Gieysztor E, Telenga M, Wolanska E, Kowal M, Paprocka-Borowicz M. Primitive Reflex Activity in Relation to the Sensory Profile in Healthy Preschool Children. Int J Environ Res Public Health. 2020 Nov 6;17(21):8210. doi: 10.3390/ijerph17218210.
Results Reference
background
PubMed Identifier
34439585
Citation
Pecuch A, Gieysztor E, Wolanska E, Telenga M, Paprocka-Borowicz M. Primitive Reflex Activity in Relation to Motor Skills in Healthy Preschool Children. Brain Sci. 2021 Jul 23;11(8):967. doi: 10.3390/brainsci11080967.
Results Reference
background
PubMed Identifier
29379547
Citation
Gieysztor EZ, Choinska AM, Paprocka-Borowicz M. Persistence of primitive reflexes and associated motor problems in healthy preschool children. Arch Med Sci. 2018 Jan;14(1):167-173. doi: 10.5114/aoms.2016.60503. Epub 2016 Jun 13.
Results Reference
background
PubMed Identifier
34819879
Citation
Bob P, Konicarova J, Raboch J. Disinhibition of Primitive Reflexes in Attention Deficit and Hyperactivity Disorder: Insight Into Specific Mechanisms in Girls and Boys. Front Psychiatry. 2021 Nov 8;12:430685. doi: 10.3389/fpsyt.2021.430685. eCollection 2021.
Results Reference
background
PubMed Identifier
24092983
Citation
Konicarova J, Bob P, Raboch J. Persisting primitive reflexes in medication-naive girls with attention-deficit and hyperactivity disorder. Neuropsychiatr Dis Treat. 2013;9:1457-61. doi: 10.2147/NDT.S49343. Epub 2013 Sep 20.
Results Reference
background
PubMed Identifier
33282806
Citation
Melillo R, Leisman G, Mualem R, Ornai A, Carmeli E. Persistent Childhood Primitive Reflex Reduction Effects on Cognitive, Sensorimotor, and Academic Performance in ADHD. Front Public Health. 2020 Nov 17;8:431835. doi: 10.3389/fpubh.2020.431835. eCollection 2020.
Results Reference
background
PubMed Identifier
22393339
Citation
Sohn M, Ahn Y, Lee S. Assessment of Primitive Reflexes in High-risk Newborns. J Clin Med Res. 2011 Dec;3(6):285-90. doi: 10.4021/jocmr706w. Epub 2011 Nov 10.
Results Reference
background
PubMed Identifier
25785487
Citation
Marin Gabriel MA, Olza Fernandez I, Malalana Martinez AM, Gonzalez Armengod C, Costarelli V, Millan Santos I, Fernandez-Canadas Morillo A, Perez Riveiro P, Lopez Sanchez F, Garcia Murillo L. Intrapartum synthetic oxytocin reduce the expression of primitive reflexes associated with breastfeeding. Breastfeed Med. 2015 May;10(4):209-13. doi: 10.1089/bfm.2014.0156. Epub 2015 Mar 18.
Results Reference
background
PubMed Identifier
8270937
Citation
Vreeling FW, Verhey FR, Houx PJ, Jolles J. Primitive reflexes in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1993 Dec;56(12):1323-6. doi: 10.1136/jnnp.56.12.1323.
Results Reference
background
PubMed Identifier
22778756
Citation
Futagi Y, Toribe Y, Suzuki Y. The grasp reflex and moro reflex in infants: hierarchy of primitive reflex responses. Int J Pediatr. 2012;2012:191562. doi: 10.1155/2012/191562. Epub 2012 Jun 11.
Results Reference
background
PubMed Identifier
32630679
Citation
Gieysztor E, Pecuch A, Kowal M, Borowicz W, Paprocka-Borowicz M. Pelvic Symmetry Is Influenced by Asymmetrical Tonic Neck Reflex during Young Children's Gait. Int J Environ Res Public Health. 2020 Jul 2;17(13):4759. doi: 10.3390/ijerph17134759.
Results Reference
background
PubMed Identifier
3794736
Citation
Huber SJ, Paulson GW. Relationship between primitive reflexes and severity in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1986 Nov;49(11):1298-300. doi: 10.1136/jnnp.49.11.1298.
Results Reference
background
PubMed Identifier
29020061
Citation
Niklasson M, Norlander T, Niklasson I, Rasmussen P. Catching-up: Children with developmental coordination disorder compared to healthy children before and after sensorimotor therapy. PLoS One. 2017 Oct 11;12(10):e0186126. doi: 10.1371/journal.pone.0186126. eCollection 2017.
Results Reference
background
PubMed Identifier
26340656
Citation
Haller H, Lauche R, Cramer H, Rampp T, Saha FJ, Ostermann T, Dobos G. Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial. Clin J Pain. 2016 May;32(5):441-9. doi: 10.1097/AJP.0000000000000290.
Results Reference
background
PubMed Identifier
28874926
Citation
Wetzler G, Roland M, Fryer-Dietz S, Dettmann-Ahern D. CranioSacral Therapy and Visceral Manipulation: A New Treatment Intervention for Concussion Recovery. Med Acupunct. 2017 Aug 1;29(4):239-248. doi: 10.1089/acu.2017.1222.
Results Reference
background
PubMed Identifier
26758035
Citation
Raith W, Marschik PB, Sommer C, Maurer-Fellbaum U, Amhofer C, Avian A, Lowenstein E, Soral S, Muller W, Einspieler C, Urlesberger B. General Movements in preterm infants undergoing craniosacral therapy: a randomised controlled pilot-trial. BMC Complement Altern Med. 2016 Jan 13;16:12. doi: 10.1186/s12906-016-0984-5.
Results Reference
background
PubMed Identifier
21732734
Citation
Curtis P, Gaylord SA, Park J, Faurot KR, Coble R, Suchindran C, Coeytaux RR, Wilkinson L, Mann JD. Credibility of low-strength static magnet therapy as an attention control intervention for a randomized controlled study of CranioSacral therapy for migraine headaches. J Altern Complement Med. 2011 Aug;17(8):711-21. doi: 10.1089/acm.2010.0277. Epub 2011 Jul 6.
Results Reference
background
PubMed Identifier
18541041
Citation
Mann JD, Faurot KR, Wilkinson L, Curtis P, Coeytaux RR, Suchindran C, Gaylord SA. Craniosacral therapy for migraine: protocol development for an exploratory controlled clinical trial. BMC Complement Altern Med. 2008 Jun 9;8:28. doi: 10.1186/1472-6882-8-28.
Results Reference
background
PubMed Identifier
31892357
Citation
Haller H, Lauche R, Sundberg T, Dobos G, Cramer H. Craniosacral therapy for chronic pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2019 Dec 31;21(1):1. doi: 10.1186/s12891-019-3017-y.
Results Reference
background
PubMed Identifier
32318454
Citation
Ghasemi C, Amiri A, Sarrafzadeh J, Dadgoo M, Jafari H. Comparative study of muscle energy technique, craniosacral therapy, and sensorimotor training effects on postural control in patients with nonspecific chronic low back pain. J Family Med Prim Care. 2020 Feb 28;9(2):978-984. doi: 10.4103/jfmpc.jfmpc_849_19. eCollection 2020 Feb.
Results Reference
background
PubMed Identifier
19729492
Citation
Mataran-Penarrocha GA, Castro-Sanchez AM, Garcia GC, Moreno-Lorenzo C, Carreno TP, Zafra MD. Influence of craniosacral therapy on anxiety, depression and quality of life in patients with fibromyalgia. Evid Based Complement Alternat Med. 2011;2011:178769. doi: 10.1093/ecam/nep125. Epub 2011 Jun 15.
Results Reference
background

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Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment

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