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Child Development DisorderNCT05340049

Craniosacral Therapy Improves Infant Neurodevelopment

A study testing Academic behavioral intervention of teachers and Therapy sessions in people with Child Development Disorder, run by Clinica Gema Leon at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 3 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Child Development Disorder
What is being tested?
Academic behavioral intervention of teachers and Therapy sessions
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSpain
Study dates
18 Dec 2021to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Apparently healthy children
  • School group
  • Within age range

Who cannot join

  • Children with possible pathologies
  • Older than the established age

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Gema León Physiotherapy and Rehabilitation Clinic

    Córdoba, Andalusia, 14011

Other trials in Spain

About this study

Official title: Early Craniosacral Therapy Improves Infant Neurodevelopment in Apparently Healthy Children.

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).

Read the 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

Being tested
Academic behavioral intervention of teachers, Therapy sessions
Keywords
Craniosacral treatment, primitive reflexes, cranial blocks, childhood, physiotherapy
Medical subject headings
Developmental Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Academic behavioral intervention of teachersProcedure or surgery

    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. Evaluation of the Battelle scale was carried out before and after the therapy sessions.

  • Therapy sessionsProcedure or surgery

    Seven sessions were given to each of the three groups according to their classification (PCST, PMRT, 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 cranial blocks and primitive reflexs therapies were expressed as block or normal and active or inactive, depending on what finds the physiotherapist in his evaluation

Study groups in NCT05340049
Study groupRoleWhat they receive
Primary Group "Placebo of craniosacral therapy"Placebo comparator30 patients of the total sample are part of one of the the placebo group, being these patients active primitive reflexes and/or cranial blocks in smaller quantities than the other participants of the study. The hands were placed imitating craniosacral techinques without having any type of benefit.
Receives: Procedure: Academic behavioral intervention of teachers; Procedure: Therapy sessions
Tertiary group "Rhythmic Movement Therapy"Active comparator30 patients of the total sample are part of the rhythmic movement therapy group, having 1 or all of the primitive reflexes active and/or cranial blocks studied. Exercises were applied to inhibit primitive reflex
Receives: Procedure: Academic behavioral intervention of teachers; Procedure: Therapy sessions
Quaternary group "Craniosacral Therapy"Experimental30 patients of the total sample are part of the rhythmic movement therapy group, having 1 or all of the primitive reflexes active and/or cranial blocks studied. Craniosacral tecniques were applied to eliminate cranial blocks and inhibit primitive reflexes
Receives: Procedure: Academic behavioral intervention of teachers; Procedure: Therapy sessions
Secondary group "Placebo of Rhythmic Movement Therapy"Placebo comparator30 patients of the total sample are part of one of the the placebo group, being these patients without active primitive reflexes and/or cranial blocks, or in smaller quantities than the other participants of the study. Exercise were applied that pretend to inhibit primitive reflex, but there is no benefit
Receives: Procedure: Academic behavioral intervention of teachers; Procedure: Therapy sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: five months

Secondary outcomes (1)
  1. Presence of active primitive reflex and cranial blocks

    physical examination measure the presence of APR and CB by an experienced physiotherapist

    Measured: two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start18 Dec 2021
  3. Primary completion21 Apr 2022
  4. Study completion30 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05340049
Sponsor's protocol ID
ART-GLB-TTO RPA Y BC
Status last verified
Jan 2025
First submitted
18 Dec 2021
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: : No The request for data will be studied and considered upon justified request.

Publications

  • 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.

    PubMed 25948254
  • 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.

    PubMed 30809175
  • Ortiz-Campoy S, Lirio-Romero C, Romay-Barrero H, Alvarez DM, Lopez-Munoz P, Palomo-Carrion R. The Role of Physiotherapy in Pediatric Palliative Care: A Systematic Review. Children (Basel). 2021 Nov 12;8(11):1043. doi: 10.3390/children8111043.

    PubMed 34828756
  • 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.

    PubMed 22747596
  • 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. doi: 10.1186/s12887-016-0731-6.

    PubMed 27899082
  • 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.

    PubMed 30905979
  • 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.

    PubMed 28219314
  • 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.

    PubMed 31392562
  • Gonzalez-Santos J, Gonzalez-Bernal JJ, De-la-Fuente Anuncibay R, Soto-Camara R, Cubo E, Aguilar-Parra JM, Trigueros R, Lopez-Liria R. Infant Cranial Deformity: Cranial Helmet Therapy or Physiotherapy? Int J Environ Res Public Health. 2020 Apr 10;17(7):2612. doi: 10.3390/ijerph17072612.

    PubMed 32290217
  • Ryan JM, Cassidy EE, Noorduyn SG, O'Connell NE. Exercise interventions for cerebral palsy. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD011660. doi: 10.1002/14651858.CD011660.pub2.

    PubMed 28602046
  • 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.

    PubMed 28479794
  • 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.

    PubMed 32127884
  • 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.

    PubMed 25433033
  • 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.

    PubMed 33172138
  • 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.

    PubMed 29379547

Questions about this trial

What is this clinical trial studying?

A study testing Academic behavioral intervention of teachers and Therapy sessions in people with Child Development Disorder, run by Clinica Gema Leon at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Previous teachers' test by means of the "Battelle Development Inventory" (BDI). (time frame: five months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05340049, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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