COREHNERV: The Effect of Craniosacral Therapy as Additive Procedure.

Sponsor

Wroclaw Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05722756

Collaborator

(none)

Enrollment

70.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Central Nervous System Diseases	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 Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Nov 30, 2019

Actual Study Completion Date :

Nov 30, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Changes in the number of abnormal reactions (assessed by the Vojta tests) [6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.