Craniosacral Therapy Children's, Balance-Coordination

NCT05002504 | Completed

• 1 other identifier: ART-GLB-CS-EQUILIB-COORD
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Children

Keywords

Balance; Coordination; Craniosacral therapy; infants; physiotherapy

Outcome Measures

Primary Outcomes (2)

• "Series of questions to the children's parents"

  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

  two weeks

• "Battelle Developmental Inventory" (BDI)

  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

  two weeks

Secondary Outcomes (5)

• "Number of participants in each therapy group"

  Seven weeks

• "The effectiveness values of the therapies for each group"

  seven weeks

• "Pre-treatment Battelle Scale"

  two weeks

• "Post-treatment Battelle Scale"

  two weeks

• "percentages of satisfaction from 1st to the 7th therapy sessions"

  seven weeks

Study Arms (3)

Patients receiving craniosacral therapy

EXPERIMENTAL

30 children without previous pathology receiving craniosacral therapy

Diagnostic Test: A series of questions were asked to the children's parents in a virtual questionnaire; Diagnostic Test: neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI); Procedure: Therapy sessions

Patients receiving balance and coordination therapy

ACTIVE COMPARATOR

31 patients without previous pathology receiving balance and coordination therapy

Diagnostic Test: A series of questions were asked to the children's parents in a virtual questionnaire; Diagnostic Test: neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI); Procedure: Therapy sessions

Patients receiving placebo

PLACEBO COMPARATOR

25 patients without previous pathology receiving placebo

Diagnostic Test: A series of questions were asked to the children's parents in a virtual questionnaire; Diagnostic Test: neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI); Procedure: Therapy sessions

Interventions

A series of questions were asked to the children's parents in a virtual questionnaire DIAGNOSTIC_TEST

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

Also known as: questions were asked to the children's parents

Patients receiving balance and coordination therapy; Patients receiving craniosacral therapy; Patients receiving placebo

neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI) DIAGNOSTIC_TEST

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

Also known as: "Battelle Developmental Inventory" (BDI)

Patients receiving balance and coordination therapy; Patients receiving craniosacral therapy; Patients receiving placebo

Therapy sessions PROCEDURE

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.

Patients receiving balance and coordination therapy; Patients receiving craniosacral therapy; Patients receiving placebo

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• healthy children
• aged 6 to 8 years old
• school group

You may not qualify if:

• unhealthy children
• ages outside the 6-8 age range

Sponsors & Collaborators

• Clinica Gema Leon: lead

Study Sites (1)

Gema León Physiotherapy and Rehabilitation Clinic

Córdoba, Andalusia, 14011, Spain

Location

Study Officials

• Irene Cantarero Carmona

  Universidad de Córdoba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will not know whether they will be treated or given a placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 12, 2021
• Study Start: August 1, 2021
• Primary Completion: October 17, 2021
• Study Completion: December 28, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)