Craniosacral Therapy Improves Infant Neurodevelopment

NCT05340049 | Completed

• 1 other identifier: ART-GLB-TTO RPA Y BC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Child Development Disorder

Keywords

Craniosacral treatment; primitive reflexes; cranial blocks; childhood; physiotherapy

Outcome Measures

Primary Outcomes (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.

  five months

Secondary Outcomes (1)

• Presence of active primitive reflex and cranial blocks

  two months

Study Arms (4)

Primary Group "Placebo of craniosacral therapy"

PLACEBO COMPARATOR

30 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.

Procedure: Academic behavioral intervention of teachers; Procedure: Therapy sessions

Tertiary group "Rhythmic Movement Therapy"

ACTIVE COMPARATOR

30 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

Procedure: Academic behavioral intervention of teachers; Procedure: Therapy sessions

Quaternary group "Craniosacral Therapy"

EXPERIMENTAL

30 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

Procedure: Academic behavioral intervention of teachers; Procedure: Therapy sessions

Secondary group "Placebo of Rhythmic Movement Therapy"

PLACEBO COMPARATOR

30 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

Procedure: Academic behavioral intervention of teachers; Procedure: Therapy sessions

Interventions

Academic behavioral intervention of teachers PROCEDURE

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.

Primary Group "Placebo of craniosacral therapy"; Quaternary group "Craniosacral Therapy"; Secondary group "Placebo of Rhythmic Movement Therapy"; Tertiary group "Rhythmic Movement Therapy"

Therapy sessions PROCEDURE

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

Primary Group "Placebo of craniosacral therapy"; Quaternary group "Craniosacral Therapy"; Secondary group "Placebo of Rhythmic Movement Therapy"; Tertiary group "Rhythmic Movement Therapy"

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)

Gema León Physiotherapy and Rehabilitation Clinic

Córdoba, Andalusia, 14011, Spain

Location

Related Publications (38)

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MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Irene Cantarero Carmona, Study chair

  Universidad de Córdoba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: April 21, 2022
• Study Start: December 18, 2021
• Primary Completion: April 21, 2022
• Study Completion: April 30, 2022
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)