The Effect of Craniosacral Therapy as Additive Procedure. (COREHNERV)

Comparison of Rehabilitation Techniques: Vojta vs Vojta and Craniosacral Therapy, in Children With Central Nervous Coordination Disorders.

This observational, retrospective study has shown, that the addition of craniosacral therapy to the Vojta method has improved the effects of the therapy in 6 months follow-up period. The chance for improvement was 9.42 times higher in Vojta + craniosacral group compared to the group conducted only with Vojta method.

The study results suggest that the craniosacral procedure should be considered as an additive regimen to the Vojta method in the therapy of children with central coordination disorders (CCD) . More data is still needed to improve the rehabilitation process in this group of patients.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Diseases
• Intervention / Treatment: Other: craniosacral therapy

Detailed Description

The aim of the retrospective, observational study was the comparison between the effectiveness of Vojta therapy used alone and its combination with craniosacral therapy after 6 months of the therapy.

Data for analysis was from one Rehabilitation Center and covered the observation period: January 1, 2014 - November 30, 2019. The data was analyzed for the purpose of the study between January 1, 2022 - July 1, 2022.

To assess the effectiveness of the mentioned rehabilitation models for the children with central coordination disorders (CCD), the neurological status of the patient, expressed as the number of abnormal reactions (Vojta tests), at the beginning (W0) and after 6 months (W6) of the therapy was recorded blindly, based on the individual's records (collected previously for the purpose of the other study). Children who had completed six months of therapy and had efficacy results documented in their medical records were divided into group A (children treated with Vojta therapy alone) and group B (children treated with Vojta therapy combined with craniosacral therapy). Information about: the age at which the children started therapy, the APGAR score at the first minute of their life, the week in which they were born, mode of delivery, sex, birth weight, mother's age at delivery and duration of breastfeeding, was also collected to compare the groups.

Finally data from 32 children in group A and 19 children in group B was analyzed.

• Study Type: Observational
• Enrollment (Actual): 51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 6 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with confirmed CCD (central coordination disorders), between 1-6 months of age

Description

Inclusion criteria:

• CCD (central coordination disorders) diagnosis based on the paediatrician's opinion with a decision that the child needs rehabilitation;
• a score of 8- 10 on the APGAR scale in the first minute of life;
• no major birth defects documented that can push the diagnosis into the diagnosis of genetic disorders;
• the age of the child at the time of the assessment of its eligibility for rehabilitation: 1-6 months (of life), calculated based on completed months of life;
• available information regarding an abnormal result of the Vojta test, defined as at least 6 abnormal reactions (marked as abnormal [AN], or delayed [OP] in the test report) with abnormal muscle tension, which indicates moderate to severe CCD;
• available information regarding the first medical examination (during the first visit (W0)), and a follow-up visit after 6 months (W6) on the determined date, maintaining the defined timeframe (5.5-6 months after W0).

Exclusion criteria (medical history was excluded from the analysis even if one of the following exclusion criteria was met):

• children who obtained a score of < 8 points on the APGAR scale in the first minute of life;
• suspicion of any major (significant) birth defect, congenital defect syndrome (e.g. Down syndrome, Sotos syndrome) and/or indications for consultation at Genetics Clinic based on paediatric records;
• age < 1 month or > 6 months;
• < 6 abnormal reactions during the Vojta test at the first eligibility visit, which indicates mild or very mild CCD.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A; treated with Vojta therapy
group B; treated with Vojta therapy combined with craniosacral therapy	Other: craniosacral therapy; subtle form of applied touch, type of osteopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the number of abnormal reactions (assessed by the Vojta tests)	improvement: fewer number of the abnormal reactions present when compare to the first visit no improvement- at least the same number (or more) of abnormal reactions present when compare to the first visit	6 months

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; children; central nervous system; Vojta therapy; reflex locomotion; cranio-sacral therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases
• Other Study ID Numbers: 108/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: after publication, no limit
• IPD Sharing Access Criteria: to everyone via the link below
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No