MedDataX Logo

Craniosacral Therapy Children's, Balance-Coordination

NCT ID: NCT05002504

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2021-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Children

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Balance Coordination Craniosacral therapy infants physiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Patients will not know whether they will be treated or given a placebo.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients receiving craniosacral therapy

30 children without previous pathology receiving craniosacral therapy

Group Type EXPERIMENTAL

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

Intervention Type 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

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

Intervention Type 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.

Therapy sessions

Intervention Type 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

31 patients without previous pathology receiving balance and coordination therapy

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

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

Intervention Type 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.

Therapy sessions

Intervention Type 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 placebo

25 patients without previous pathology receiving placebo

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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

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

Intervention Type 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.

Therapy sessions

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DIAGNOSTIC_TEST

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

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.

Intervention Type DIAGNOSTIC_TEST

Therapy sessions

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

questions were asked to the children's parents "Battelle Developmental Inventory" (BDI)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* unhealthy children
* ages outside the 6-8 age range
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Clinica Gema Leon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GEMA LEÓN BRAVO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Irene Cantarero Carmona

Role: STUDY_CHAIR

Universidad de Córdoba

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gema León Physiotherapy and Rehabilitation Clinic

Córdoba, Andalusia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Clinical Study Report

View Document

Document Type: Clinical Study Report

View Document

Document Type: Clinical Study Report

View Document

Document Type: Clinical Study Report

View Document

Document Type: Clinical Study Report

View Document

Document Type: Clinical Study Report

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ART-GLB-CS-EQUILIB-COORD

Identifier Type: -

Identifier Source: org_study_id