Central Nervous System DiseasesCOREHNERVNCT05722756
The Effect of Craniosacral Therapy as Additive Procedure.
An observational study of Central Nervous System Diseases, run by Wroclaw Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Central Nervous System Diseases
- What is being tested?
- craniosacral therapy
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Children with confirmed CCD (central coordination disorders), between 1-6 months of age
Who may be able to join
- 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).
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- 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.
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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
- Being tested
- craniosacral therapy
- Keywords
- children, rehabilitation, central nervous system, Vojta therapy, cranio-sacral therapy, reflex locomotion
- Medical subject headings
- Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
craniosacral therapyOther
subtle form of applied touch, type of osteopathy
| Study group | Role | What they receive |
|---|---|---|
| group A | treated with Vojta therapy | |
| group B | treated with Vojta therapy combined with craniosacral therapy Receives: Other: craniosacral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jan 2014
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722756
- Sponsor's protocol ID
- 108/2019
- Acronym
- COREHNERV
- Status last verified
- Feb 2023
- First submitted
- 20 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rehabilitation Techniques: Vojta vs Vojta and Craniosacral Therapy, in Children With Central Nervous Coordination Disorders.
- ClinicalTrials.gov ID
- NCT05722756
- Acronym / sponsor ID
- COREHNERV / 108/2019
- Conditions
- Central Nervous System Diseases
- Keywords
- children, rehabilitation, central nervous system, Vojta therapy, cranio-sacral therapy, reflex locomotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | –treated with Vojta therapy |
| group B | – | Other: craniosacral therapytreated with Vojta therapy combined with craniosacral therapy |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with confirmed CCD (central coordination disorders), between 1-6 months of age
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| craniosacral therapysubtle form of applied touch, type of osteopathy | Other | group B |
Primary outcome
Changes in the number of abnormal reactions (assessed by the Vojta tests)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Diseases, run by Wroclaw Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the number of abnormal reactions (assessed by the Vojta tests) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.