Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment

NCT05190029 | Completed

• 1 other identifier: ART-GLB-PRIMITIVE REFLEXES
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development Disorder

Keywords

primitive reflexes; craniosacral disfunctions; neurodevelopment; childhood; early diagnosis; screening

Outcome Measures

Primary Outcomes (2)

• 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.

  one week

• 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.

  Three weeks

Secondary Outcomes (2)

• Craniosacral evaluation of possible cranial blocks

  Three weeks

• Craniosacral evaluation of active primitive reflexes.

  Three weeks

Study Arms (1)

Complete sample

EXPERIMENTAL

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.; Other: Intervention by teachers; Procedure: Physiotherapeutic evaluation

Interventions

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).

Complete sample

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.

Complete sample

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).

Complete sample

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Apparently healthy children
• School group
• Within age range

You may not qualify if:

• Children with possible pathologies
• Older than the established age

Sponsors & Collaborators

• Clinica Gema Leon: lead

Study Sites (1)

Clinica de Fisioterapia Gema León

Córdoba, Andalusia, 14011, Spain

Location

Related Publications (21)

• 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.

  PMID: 33172138 BACKGROUND

• 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.

  PMID: 34439585 BACKGROUND

• 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.

  PMID: 29379547 BACKGROUND

• 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.

  PMID: 34819879 BACKGROUND

• 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.

  PMID: 24092983 BACKGROUND

• 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.

  PMID: 33282806 BACKGROUND

• 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.

  PMID: 22393339 BACKGROUND

• 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.

  PMID: 25785487 BACKGROUND

• 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.

  PMID: 8270937 BACKGROUND

• 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.

  PMID: 22778756 BACKGROUND

• 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.

  PMID: 32630679 BACKGROUND

• 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.

  PMID: 3794736 BACKGROUND

• 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.

  PMID: 29020061 BACKGROUND

• 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.

  PMID: 26340656 BACKGROUND

• 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.

  PMID: 28874926 BACKGROUND

• 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.

  PMID: 26758035 BACKGROUND

• 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.

  PMID: 21732734 BACKGROUND

• 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.

  PMID: 18541041 BACKGROUND

• 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.

  PMID: 31892357 BACKGROUND

• 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.

  PMID: 32318454 BACKGROUND

• 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.

  PMID: 19729492 BACKGROUND

MeSH Terms

Conditions

Developmental Disabilities; Disease

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Irene Cantarero, Study Chair

  Universidad de Córdoba

  STUDY CHAIR

• Javier Caballero Villarraso, Study Direct

  Universidad de Córdoba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 13, 2022
• Study Start: December 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: February 5, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)