Child Development Disorder Clinical Trial
Official title:
Impact of Early Craniosacral Evaluation and Treatment on the Optimization of Infant Neurodevelopment
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).
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Gema León Physiotherapy and Rehabilitation Clinic | Córdoba | Andalucía |
Lead Sponsor | Collaborator |
---|---|
Clinica Gema Leon |
Spain,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05525962 -
Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
|
||
Completed |
NCT04562038 -
Implementation of Electronic Shared Decision-Making Support for Early Intervention
|
N/A | |
Completed |
NCT04565509 -
Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
|
N/A | |
Completed |
NCT05215028 -
Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study
|
||
Completed |
NCT05408351 -
The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III
|
||
Active, not recruiting |
NCT06334627 -
Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania
|
N/A | |
Recruiting |
NCT05577533 -
Digital Epidemiology Study on Brain Functioning
|
N/A | |
Not yet recruiting |
NCT06208332 -
Photo-Narrative Study
|
Phase 1/Phase 2 | |
Completed |
NCT05727046 -
Investigation of the Usability of the Dynamic Scaffolding System
|
||
Enrolling by invitation |
NCT03067064 -
Prevelance of Molar Incisor Hypomineralization Among a Group of Egyptian Children
|
N/A | |
Completed |
NCT05072418 -
Postural Control Among Children With and Without Dyslexia
|
||
Completed |
NCT05190029 -
Craniosacral Test and Primitive Reflexes in Infant Neurodevelopment
|
N/A | |
Active, not recruiting |
NCT03880383 -
BRIGHT Coaching Program for Families
|
N/A | |
Recruiting |
NCT04936269 -
Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure
|
||
Completed |
NCT05398900 -
Validity and Reliability of Indonesian Translated Ages and Stages Questionnaires - Third Edition (ASQ-3) as a Screening Tool for Developmental Delay in 1-12 Months Old Children
|