CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Academic behavioral intervention of teachers +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT05340049
NCT05340049N/ACompleted

Early Craniosacral Therapy Improves Infant Neurodevelopment in Apparently Healthy Children.

Clinica Gema Leon·interventional·Posted Apr 21, 2022·Updated Jan 22, 2025

In Brief

A clinical study evaluating Academic behavioral intervention of teachers and Therapy sessions for Child Development Disorder. Completed, enrolled 120 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 21, 2022
Enrollment StartDec 18, 2021
Primary CompletionApr 21, 2022
Study CompletionApr 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.2 years ago

Interventions

Academic behavioral intervention of teachersprocedure

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

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