The Effect of Craniosacral Therapy as Additive Procedure.

NCT ID: NCT05722756

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2019-11-30

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.

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.

Conditions

Central Nervous System Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

group A

treated with Vojta therapy

No interventions assigned to this group

group B

treated with Vojta therapy combined with craniosacral therapy

craniosacral therapy

Intervention Type: OTHER

subtle form of applied touch, type of osteopathy

Interventions

craniosacral therapy

subtle form of applied touch, type of osteopathy

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

108/2019

Identifier Type: -

Identifier Source: org_study_id