Clinical Trials Logo

Clinical Trial Summary

Coordination and balance are manifested as motor skills or abilities that are acquired as the Central Nervous System develops. In the infant stage, these qualities help guide specialists to recognize possible abnormalities that at first glance seem banal, but that, as time goes by, acquire greater difficulty, causing even more complex problems in the long term. Craniosacral therapy could help these skills to be correctly established during growth, correcting such impairment in time during neurodevelopment. Objective: To correct possible alterations that occur during infant growth related to balance and coordination in neurodevelopment, by means of craniosacral therapy compared with the specific therapy of balance and coordination usually used in pathologies diagnosed of this caliber. Design: Longitudinal-experimental study with a population of 86 apparently healthy children. Setting/Participants: 86 children were treated without excluding sex and divided into three groups: placebo group (n=25), craniosacral therapy group (n=30) and balance and coordination therapy group (n=31). Interventions: group 1 (placebo), group 2 (craniosacral therapy) group 3 (balance and coordination therapy). Results: The Battelle scale prior to the therapies developed in the study showed balance and coordination imbalances in the participants of the three groups, with lower percentages in the placebo treatment. Sessions from the 2nd to the 7th of treatment show increasing percentages and fluctuating for craniosacral therapy between 51% to 56% and 100% satisfaction, significantly valued. As for balance and coordination therapy, satisfaction percentages are evident only in the 6th and 7th sessions, with statistically significant values. Finally, the Battelle post-therapy assessment scale shows a higher number of participants in the percentages classified as normal (50-80%) in the craniosacral therapy group, improving the evaluated parameters with statistically significant values. Conclusion: The study shows that craniosacral therapy can not only act as a treatment for the improvement of children's balance and coordination, but also helps small corrections during children's neurodevelopment, avoiding the evolution of pathologies in the long term. It is therefore necessary for a more prompt, total and lasting correction of these skills in the infant.


Clinical Trial Description

Design: A longitudinal-experimental study was carried out with a child population of 86 children aged 6 to 8 years old without excluding sex in a school group in Cordoba (Spain). Participants: Eighty-six apparently healthy children between 6 and 8 years of age were treated as prevention in balance and coordination motor skills at the Gema León physiotherapy clinic in Córdoba (Spain). The children were divided into three groups: 25 patients in the placebo group (group 1), 30 patients in the craniosacral therapy group (group 2) and 31 patients in the balance and coordination therapy group (group 3). Primary outcome: A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children. On the other hand, 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. The results are assigned in age-adjusted percentages, classified as: low (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated. Secondary outcome: Seven treatment sessions were carried out with the balance and coordination therapeutic exercise techniques (group 3) most frequently used for the treatment of these pathologies; seven sessions of craniosacral therapy (group 2) as corrective and preventive in possible alterations during infant neurodevelopment and finally seven sessions simulating craniosacral therapy on a placebo group (group 1) as a control of the treatments used. The effectiveness values of the therapies were expressed as percentages of satisfaction with the classifications of 25 to 28% (apparent changes < to half of the sample in each therapy group), 51 to 56% (apparent changes in half of the sample in each therapy group) and 100% (apparent changes > to half of the sample in each therapy group). From the above, the absolute values of the sample in each therapy group are set as follows. Data analysis: The variables were expressed as mean, absolute and relative frequency. The chi-square test was used to analyze the differences between age ranges, balance and coordination problems versus physical therapy sessions performed, as well as the association between values of the Battelle scale of child neurodevelopment before and after the treatments. A confidence level of 95% was established, considering as statistically significant a value of p a value of p<0.05 was considered statistically significant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05002504
Study type Interventional
Source Clinica Gema Leon
Contact
Status Completed
Phase N/A
Start date August 1, 2021
Completion date December 28, 2021

See also
  Status Clinical Trial Phase
Completed NCT01979978 - Healthy Buddies Manitoba N/A
Recruiting NCT02989116 - Executive Training and Brain in Children N/A
Recruiting NCT04639830 - Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
Completed NCT03375502 - A Study of MG1111 in Healthy Children Phase 2/Phase 3
Completed NCT03813472 - Hydration Sensor for Atopic Dermatitis
Recruiting NCT02057822 - Cytokine Assay in Tears of Healthy Children and With Vernal Keratoconjunctivitis: Case Control Study and Monitoring of Cases at 6 Months N/A
Not yet recruiting NCT06287385 - An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits N/A
Completed NCT04864665 - Study to Evaluate the Effects of a Formula on the Gut Health of Healthy Chinese Infants and Young Children N/A
Completed NCT05775237 - An Investigator-initiated Trial to Assess the Effectiveness of Three Different Gummies (Curcumin Gummies, Vitamin C Gummies, and Vitamin B Complex Gummies) in Healthy Children N/A
Completed NCT04642781 - Measurement of Eye Movements While Reading a German Text
Recruiting NCT06276426 - Plants Optimizing Development Study (PODS) N/A
Completed NCT05249166 - Feeding for Accesible, Affordable and Healthy Childhood N/A
Completed NCT05989360 - The Utility of Lung Clearance Index in Ethnic Groups and in Disease N/A
Completed NCT05744323 - Effects of Functional Training on Fundamental Motor Skills Among Children N/A
Completed NCT04508283 - Fiber Intake Among Children in Relation to Milk Type, Gastrointestinal Symptoms and Iron Status: a Cross-sectional Study
Active, not recruiting NCT02636998 - Nutrition and Cognitive Function in Preadolescents
Completed NCT01829438 - Influence of Music on 6 Minutes Walking Distance in Healthy Children N/A
Completed NCT00693303 - Examining the Effectiveness of My Scrivener on Handwriting Legibility N/A
Recruiting NCT04460287 - Bioavailability of Different Formulas Enriched With DHA Using Wet Mixing or Dry Blending Method N/A
Completed NCT03276299 - Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years N/A