The Effect of Craniosacral Therapy as Additive Procedure.

NCT05722756 | Completed

• 1 other identifier: 108/2019
• Study Type: observational
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Nervous System Diseases

Keywords

children; rehabilitation; central nervous system; Vojta therapy; cranio-sacral therapy; reflex locomotion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

group A

treated with Vojta therapy

group B

treated with Vojta therapy combined with craniosacral therapy

Other: craniosacral therapy

Interventions

craniosacral therapy OTHER

subtle form of applied touch, type of osteopathy

group B

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw Medical University: lead

MeSH Terms

Conditions

Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 10, 2023
• Study Start: January 1, 2014
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication, no limit
• Access Criteria: to everyone via the link below