Clinical trial NCT05340049: Craniosacral Therapy Improves Infant Neurodevelopment
Official title: Early Craniosacral Therapy Improves Infant Neurodevelopment in Apparently Healthy Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development Disorder
Keywords: Craniosacral treatment
primitive reflexes
cranial blocks
childhood
physiotherapy
Lead sponsor: Clinica Gema Leon
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 120 pupils aged 3-8 years were divided into four treatment groups set as follows: Placebo craniosacral group (n=30) Rhythmic Movement Therapy Group (n=30) Placebo of Rhythmic Movement Therapy Group (n=30) Craniosacral Therapy Group (n=30) Such participants were included according to the number of Active Primitive Reflexes (Moro, asymmetric and symmetric cervical) and/or Cranial Blocks (swaying of the dura mater, sphenoid bone and cranial parietal areas) presented by each of them
Primary purpose: TREATMENT

Brief 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 compare the effectiveness of craniosacral therapy with respect to traditional primitive reflex treatment therapy and how it influences the neurodevelopment of the healthy child through the Battelle scale, and to test the effectiveness of both therapies witn their placebos. Methodology: 120 children were treated without excluding sex divided into four groups: placebo group of craniosacral therapy (n=30), Placebo group of rythmic Movement Therapy (n=30), rhytmic movement therapy (n=30) and craniosacral therapy group (n=30).

Detailed 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 5 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 to compare the effectiveness of craniosacral therapy with respect to traditional primitive reflex treatment therapy and how it influences the neurodevelopment of the healthy child through the Battelle scale, and to test the effectiveness of both therapies witn their placebos.

Thus, our aims are to compare the effectiveness of craniosacral therapy with respect to traditional primitive reflex treatment therapy and how it influences the neurodevelopment of the apparently healthy child through the Battelle scale, as well as to examine which of the two therapies would be faster in inhibiting RPA and to test the effectiveness of both therapies witn their respect placebos

Eligibility criteria: Inclusion Criteria:

* Apparently healthy children
* School group
* Within age range

Exclusion Criteria:

* Children with possible pathologies
* Older than the established age

Primary outcomes:
measure: Previous teachers' test by means of the "Battelle Development Inventory" (BDI).
timeFrame: five months
Secondary outcomes:
measure: Presence of active primitive reflex and cranial blocks
timeFrame: two months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Gema León Physiotherapy and Rehabilitation Clinic
state: Andalucía
Study officials:
affiliation: Universidad de Córdoba
name: Irene Cantarero Carmona, Study chair
role: STUDY_CHAIR
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