Impact of Craniosacral Treatment on Child Neurodevelopment

Child Development Disorder Clinical Trial

Official title:

Impact of Early Craniosacral Evaluation and Treatment on the Optimization of Infant Neurodevelopment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340049
• Other study ID #: ART-GLB-TTO RPA Y BC
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2022
• Source: Clinica Gema Leon
• Contact: Gema León Bravo, Physiotherap
• Phone: +34 667401116
• Email: glbravo[@]uco.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Craniosacral exploration and therapy is one of the innovative palpation and treatment techniques in specialized physiotherapy, which can contribute in an efficient, subtle and sudden way to the detection of dysfunctions in the cranial sutures or fontanelles and/or alterations or blockages that may exist in the frontal lobes and other areas of the skull and body. Objective: To demonstrate the need for programs that consider preventive evaluation and specialized physiotherapeutic treatment (craniosacral therapy) in schools and health centers during all stages of child growth (from birth to 12 years of age), maximizing the development of the child's physical, emotional, psychosocial, linguistic and cognitive capacities; avoiding major complications in the long term. Methodology: 120 children were treated without excluding sex divided into three groups: placebo group (n=41), Movement Technique to Inhibit Reflexes group (n=40) and craniosacral therapy group (n=39).

Description:

The growth of the individual is linked to differentiated medical-scientific stages. Physiology stipulates stages in the development and maturation of the human being, from the moment of fertilization until the day of death, due to the existence of relatively similar patterns in all human beings, produced at specific parallel times. Primitive Reflexes (PR) are one of the patterns that are activated from the moment of birth and remain until a maximum time of 3 years of age. After this period of time, alterations in the Central Nervous System (CNS) are usually considered possible when they persist, inhibiting the maturation of motor neurons causing postural reflexes (coming from PR) to be delayed in their appearance or not to be adequately presented, including the possibility of their complete absence. Child neurology affirms that cortical and spinal control in the newborn (NB) motor system should be the basis for the opening to higher level functions required by the growth and maturation of the CNS. The participation of the frontal lobes is essential in the rapidity of response to a stimulus, since they direct the planning of complex activities, their final conceptualization and the sustained modification of the components to arrive at an efficient motor sequence. In such a way that the frontal lobes provide a kind of synergism with the rest of the CNS, promoting a faster impulse to think, speak and act. That is why, when there is a lesion in such areas, it can cause the reduction of such impulses and generate deterioration and/or delays at neurobehavioral and neuropsychological levels. The cranial sutures or fontanelles are dense fibrous bands that serve as interconnections of the cranial bones. They are critical in the NB, as during delivery they allow the head to pass through the vaginal canal without putting pressure on the baby's brain. After delivery, the sutures remain open for several months of life for the development, growth and protection of the brain. Palpation of the cranial sutures or fontanelles is one of the practices in neurology and physical therapy used to determine the growth and development of the child. Craniosacral exploration and therapy is one of the innovative palpation and treatment techniques in specialized physical therapy, which can contribute in an efficient, subtle and sudden way to the detection of dysfunctions in the cranial sutures or fontanelles and/or in the alterations or blockages that may exist in the frontal lobes and other areas of the skull and body. The manual skill of craniosacral exploration is based on the ability of the craniosacral therapist to feel the state of the fasciae surrounding the brain and spinal cord, as well as their physiological structure. The gentle, non-invasive manual contact, with hardly any pressure, contributes to the detection of tensions in the connective tissue, which could lead to possible disruptions in the treated patient. This is how the specialized therapist assesses the rhythm of mobility of the cranial fasciae, their synchrony, strength, frequency and tenacity. When there are alterations in the structure and state of the cranial membranes diagnosed by the specialized therapist, craniosacral therapy would be initiated to balance the membrane tensions of the bones that make up the skull and normalize the movement, synchrony, strength, frequency and tenacity. Failure to release the existing tensions in the fascial system could lead to different imbalances in the nervous, visceral, endocrine and circulatory systems, both blood and lymphatic; this could cause states of persistent RP or its reactivation, cranial blockages that do not allow the correct neurological and cognitive functioning, and possible mental and learning disorders or alterations. The studies that have been carried out in Physiotherapy at behavioral and neuropsychological level show that there is a high percentage of relationship between persistent RPs and certain disorders, such as attention deficit, hyperactivity, depression, autism and poor concentration, but such dysfunctions are not only described in children with clear pathologies such as those mentioned above, but studies have also been presented in the child population characterized as healthy, with mild patterns of alterations in their cognitive, motor, psychological and social development that show different degrees of activation of RPs. Therefore, it is necessary to evaluate all stages of child development (from gestation to the onset of puberty) to obtain a complete neurological chronological assessment. Other studies show that tensions in the temporo-mandibular joints, in the frontal and parietal areas of the skull, cause problems such as migraines, delayed motor behavior, stress, anxiety, bruxism and lack of concentration, leading to different disorders that occur as the condition progresses, helping to worsen the physical and mental well-being of the child. Thus, craniosacral therapy indicates that all these disorders mentioned in healthy children may be due to a plastic deformation in any of the cranial membranes, which, when generalized to the rest of the body, may influence the degree of fascial tension of the others. With the restructuring of these fasciae by means of craniosacral therapy, the integrity of the organism and thus its well-being would return. This work is based on the previous research presented as Master's Thesis under the name of "Early Craniosacral and Primitive Reflex Evaluation in Child Neurodevelopment" by Leon et al (2020). Where 14 PR and 6 BC were assessed in a group of 120 children divided into two age ranges: 3 to 6 and 6 to 8 years old, resulting in the following conclusions: 1. Those considered as gestation and/or complicated deliveries suppose risk factors for the active presence of primitive reflexes and existence of craniocranial blocks. 2. The frequency of activation of the primitive reflexes of Moro and cervical symmetric, increases with age (in the studied range) without relation to gender, a result in contrast to that expected according to the normal development of the infant. 3. When the neurodevelopmental assessment measured according to the Battelle scale is shown in low (0-50%) or high (80-100%) ranges, the frequency of activation of the asymmetric and symmetric cervical reflexes and of blocks of the sphenoid bone, dura mater rocking and parietal bones is higher, ordered according to the degree of frequency. 4. The presence of certain activated primitive reflexes (Moro reflex and cervical asymmetric and symmetric) is significantly related to blockages of some areas of the craniosacral system (swaying of the dura mater and sphenoid bone). The main objective of this work is to demonstrate the need for programs that consider preventive evolution and specialized physiotherapeutic treatment (craniosacral therapy) in schools and health centers during all stages of child growth, maximizing the development of the child's physical, emotional, social, linguistic and cognitive abilities; avoiding major complications in the long term.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2022
• Est. primary completion date: April 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• Apparently healthy children
• School group
• Within age range

Exclusion Criteria:

• Children with possible pathologies
• Older than the established age

Related Conditions & MeSH terms

• Child Development Disorder
• Developmental Disabilities

Intervention

Diagnostic Test:
• Online questionnaire of children's backgrounds
A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children.

Other:
• Academic behavioral intervention of teachers
the school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which evaluates 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 (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated. Evaluation of the Battelle scale was carried out before and after the therapy sessions.

Procedure:
• Therapy sessions
Seven sessions were given to each of the three groups according to their classification (placebo, TMR, TCS), being able to obtain a stable value in each of the treatments carried out. Before each session, the effect of the previous session was explored in order to evaluate its efficacy (from the second session onwards). Each of the therapies had the same number of sessions (1 per week for 7 weeks) in order to have equality in all the parameters evaluated. The effectiveness values of the therapies were expressed as percentages of satisfaction with the classifications of 25% (apparent changes less than half of the sample in each therapy group), 50% (apparent changes in half of the sample plus one in each therapy group) and 75-100% (apparent changes in all or almost all of the sample in each therapy group).

Locations

Country	Name	City	State
Spain	Gema León Physiotherapy and Rehabilitation Clinic	Córdoba	Andalucía

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Gema Leon

Country where clinical trial is conducted

Spain, 

References & Publications (38)

Adragna V, Bertino AS, Carano M, Soru A, Taranto G, Desideri R. O052. Migraine without aura and osteopathic medicine, a non-pharmacological approach to pain and quality of life: open pilot study. J Headache Pain. 2015 Dec;16(Suppl 1):A180. doi: 10.1186/1129-2377-16-S1-A180. — View 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. — View 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. — View Citation

Das SP, Ganesh GS. Evidence-based Approach to Physical Therapy in Cerebral Palsy. Indian J Orthop. 2019 Jan-Feb;53(1):20-34. doi: 10.4103/ortho.IJOrtho_241_17. — View Citation

Degerstedt F, Wiklund M, Enberg B. Physiotherapeutic interventions and physical activity for children in Northern Sweden with cerebral palsy: a register study from equity and gender perspectives. Glob Health Action. 2016 Jan - Dec;10(sup2):1272236. doi: 10.1080/16549716.2017.1272236. — View Citation

Do TP, Heldarskard GF, Kolding LT, Hvedstrup J, Schytz HW. Myofascial trigger points in migraine and tension-type headache. J Headache Pain. 2018 Sep 10;19(1):84. doi: 10.1186/s10194-018-0913-8. Review. — View 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. — View 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). pii: E4759. doi: 10.3390/ijerph17134759. — View 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. — View Citation

Golanska P, Saczuk K, Domarecka M, Kuc J, Lukomska-Szymanska M. Temporomandibular Myofascial Pain Syndrome-Aetiology and Biopsychosocial Modulation. A Narrative Review. Int J Environ Res Public Health. 2021 Jul 23;18(15). pii: 7807. doi: 10.3390/ijerph18157807. Review. — View Citation

González-Santos J, González-Bernal JJ, De-la-Fuente Anuncibay R, Soto-Cámara R, Cubo E, Aguilar-Parra JM, Trigueros R, López-Liria R. Infant Cranial Deformity: Cranial Helmet Therapy or Physiotherapy? Int J Environ Res Public Health. 2020 Apr 10;17(7). pii: E2612. doi: 10.3390/ijerph17072612. — View Citation

Guillaud A, Darbois N, Monvoisin R, Pinsault N. Reliability of Diagnosis and Clinical Efficacy of Cranial Osteopathy: A Systematic Review. PLoS One. 2016 Dec 9;11(12):e0167823. doi: 10.1371/journal.pone.0167823. eCollection 2016. Review. — View 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. — View 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. — View Citation

Hartley H, Cassidy E, Bunn L, Kumar R, Pizer B, Lane S, Carter B. Exercise and Physical Therapy Interventions for Children with Ataxia: A Systematic Review. Cerebellum. 2019 Oct;18(5):951-968. doi: 10.1007/s12311-019-01063-z. — View 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. — View Citation

Konicarova J, Bob P, Raboch J. Persisting primitive reflexes in medication-naïve girls with attention-deficit and hyperactivity disorder. Neuropsychiatr Dis Treat. 2013;9:1457-61. doi: 10.2147/NDT.S49343. Epub 2013 Sep 20. — View Citation

Kuc J, Szarejko KD, Golebiewska M. Evaluation of Soft Tissue Mobilization in Patients with Temporomandibular Disorder-Myofascial Pain with Referral. Int J Environ Res Public Health. 2020 Dec 21;17(24). pii: E9576. doi: 10.3390/ijerph17249576. — View Citation

Larsson I, Miller M, Liljedahl K, Gard G. Physiotherapists' experiences of physiotherapy interventions in scientific physiotherapy publications focusing on interventions for children with cerebral palsy: a qualitative phenomenographic approach. BMC Pediatr. 2012 Jul 2;12:90. doi: 10.1186/1471-2431-12-90. — View Citation

Levy SE, Hyman SL. Complementary and alternative medicine treatments for children with autism spectrum disorders. Child Adolesc Psychiatr Clin N Am. 2008 Oct;17(4):803-20, ix. doi: 10.1016/j.chc.2008.06.004. Review. — View Citation

Lucas BR, Elliott EJ, Coggan S, Pinto RZ, Jirikowic T, McCoy SW, Latimer J. Interventions to improve gross motor performance in children with neurodevelopmental disorders: a meta-analysis. BMC Pediatr. 2016 Nov 29;16(1):193. Review. — View 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. — View Citation

Marín Gabriel MA, Olza Fernández I, Malalana Martínez AM, González Armengod C, Costarelli V, Millán Santos I, Fernández-Cañadas Morillo A, Pérez Riveiro P, López Sánchez F, García 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. — View Citation

Matarán-Peñarrocha GA, Castro-Sánchez AM, García GC, Moreno-Lorenzo C, Carreño 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. — View 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. — View Citation

Nguyen AT, Armstrong EA, Yager JY. Neurodevelopmental Reflex Testing in Neonatal Rat Pups. J Vis Exp. 2017 Apr 24;(122). doi: 10.3791/55261. — View Citation

Nielsen G, Stone J, Matthews A, Brown M, Sparkes C, Farmer R, Masterton L, Duncan L, Winters A, Daniell L, Lumsden C, Carson A, David AS, Edwards M. Physiotherapy for functional motor disorders: a consensus recommendation. J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1113-9. doi: 10.1136/jnnp-2014-309255. Epub 2014 Nov 28. — View Citation

Okenwa W, Edeh A. A review of clinical presentation and physiotherapy management of cerebral palsy patients in Esut teaching hospital, Enugu, Nigeria. Afr Health Sci. 2019 Dec;19(4):3085-3090. doi: 10.4314/ahs.v19i4.30. — View Citation

Ortiz-Campoy S, Lirio-Romero C, Romay-Barrero H, Álvarez DM, López-Muñoz P, Palomo-Carrión R. The Role of Physiotherapy in Pediatric Palliative Care: A Systematic Review. Children (Basel). 2021 Nov 12;8(11). pii: 1043. doi: 10.3390/children8111043. Review. — View Citation

Park Y, Kabariti J, Tafler L. Craniosacral Therapy Use in Normal Pressure Hydrocephalus. Cureus. 2021 May 7;13(5):e14886. doi: 10.7759/cureus.14886. — View Citation

Parnell Prevost C, Gleberzon B, Carleo B, Anderson K, Cark M, Pohlman KA. Manual therapy for the pediatric population: a systematic review. BMC Complement Altern Med. 2019 Mar 13;19(1):60. doi: 10.1186/s12906-019-2447-2. — View 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). pii: E8210. doi: 10.3390/ijerph17218210. — View Citation

Ryan JM, Cassidy EE, Noorduyn SG, O'Connell NE. Exercise interventions for cerebral palsy. Cochrane Database Syst Rev. 2017 Jun 11;6:CD011660. doi: 10.1002/14651858.CD011660.pub2. Review. — View Citation

Schaffert N, Janzen TB, Mattes K, Thaut MH. A Review on the Relationship Between Sound and Movement in Sports and Rehabilitation. Front Psychol. 2019 Feb 12;10:244. doi: 10.3389/fpsyg.2019.00244. eCollection 2019. Review. — View Citation

Sinha AG, Sharma R. Factors Influencing Utilization of Physiotherapy Service among Children with Cerebral Palsy in Jalandhar District of Punjab. J Neurosci Rural Pract. 2017 Apr-Jun;8(2):209-215. doi: 10.4103/0976-3147.203852. — View 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. — View Citation

Tomassini A, Spinelli D, Jacono M, Sandini G, Morrone MC. Rhythmic oscillations of visual contrast sensitivity synchronized with action. J Neurosci. 2015 May 6;35(18):7019-29. doi: 10.1523/JNEUROSCI.4568-14.2015. — View Citation

Wittman RA, Vallone SA. Inclusion of chiropractic care in multidisciplinary management of a child with Prader-Willi syndrome: a case report. J Chiropr Med. 2009 Dec;8(4):193-9. doi: 10.1016/j.jcm.2009.08.001. — View Citation

* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	three months
Primary	Previous 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.; The minimum and maximum values are 0-341. 170.5-272.8 in item scores are ideal values that indicate normal behavior according to their age.	five months
Secondary	Comparison before and after the therapeutic intervention by means of the "Battelle Developmental Inventory" (BDI)	The investigators compare the previous and subsequent results in each of the participants of the three groups established for the study by means of the Battelle scale, which identifies the absolute values for optimal growth in the stages of neurobehavioral growth during childhood. This is intended to demonstrate the efficacy of each of the therapeutic protocols used.	two months