The quality of spontaneus movements in preterm infants undergoing craniosacral therapy
Organizational Data
- DRKS-ID:
- DRKS00004258
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2012-07-31
- Last update in DRKS:
- 2016-01-14
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Within the last years several animal and human studies showed that tactile/kinaesthetic stimulation were associated with promising results, suggesting positive influence on weight gain, motor - and neurodevelopmental outcome in infants. As very low birth weight infants are extremely small and delicate to touch, we considered craniosacral therapy as ideal form of soft kinaesthetic stimulation in healthy prterm infants. Included are stable preterm infants (GA < 37 weeks), without neurological pathologies in the ultrasound examination.The infants were randomized either into the intervention group (IG) who received craniosacral therapy, or the control group (CG). The Intervention group receive craniosacral therapy for 3 weeks , each session for 20 minutes, twice a week. By videodocumentation the General Movement (GM) assessment before and after the intervention were documented. To blinded experts analyses GM Optimality Score (0-42 points). Higher scores indicate a more optimal performance.
Brief summary in scientific language
Tactile/kinaesthetic stimulation includes a variety of different techniques, craniosacral therapy being one of it. As very low birth weight infants are extremely small and delicate to touch, we considered (a) craniosacral therapy as ideal form of additional enrichment of the environment by soft kinaesthetic stimulation and (b) the non intrusive GM assessment as the appropriate tool to evaluate its implications. The aims of our study were (1) to investigate neurological short-term effects of craniosacral therapy and (2) to evaluate a difference in weight gain in relation to the therapeutical approach of craniosacral therapy
Health condition or problem studied
- Free text:
- Preterm
- ICD10:
- P07.3 - Other preterm infants
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Preterms (GA<37 Weeks) undergoing craniosacraltherapy for 3 weeks, each intervention for 20 minutes-twice a week
- Arm 2:
- Preterms (GA<37 Weeks) without craniosacraltherapy
Endpoints
- Primary outcome:
- Quality of the General Movements in preterms undergoing craniosacraltherapy Scoring: General Motor Optimaltity Score measured-15 min before and after the Intervention
- Secondary outcome:
- Weight differencs in preterms undergoing craniosacral therapy-before the first and after the last intervention
Study Design
- Purpose:
- Supportive care
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Investigator/therapist
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Abteilung für Neonatologie Graz
Recruitment period and number of participants
- Planned study start date:
- 2012-08-01
- Actual study start date:
- 2012-08-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2015-10-25
- Target Sample Size:
- 30
- Final Sample Size:
- 30
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 24 Weeks of pregnancy
- Maximum Age:
- 37 Weeks of pregnancy
- Additional Inclusion Criteria:
- clinical "stable" preterms
Exclusion Criteria
Preterms with cerebral diagnosis
Addresses
Primary Sponsor
- Address:
- Abteilung für Neonatologie Universitätsklinik für Kinder -und JugendheilkundeProf. Dr. Berndt UrlesbergerAuenbruggerplatz 308036 GrazAustria
- Telephone:
- +43 316 385-2624
- Fax:
- +43 316 385 2678
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Univ. Klinik für Kinder und JugendheilkundeDr Wolfgang RaithAuenbruggerplatz 308036 GrazAustria
- Telephone:
- +43 316 385 80599
- Fax:
- +43 316 385 2678
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neonatologie.com
Contact for Public Queries
- Address:
- Univ. Klinik für Kinder und JugendheilkundeDr Wolfgang RaithAuenbruggerplatz 308036 GrazAustria
- Telephone:
- +43 316 385 80599
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Univ. Klinik für Kinder und JugendheilkundeDr Wolfgang RaithAuenbruggerplatz 308036 GrazAustria
- Telephone:
- +43 316 385 80599
- Fax:
- +43 316 385 2678
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neonatologie.com
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Abteilung für Neonatologie/ Univ.Klinik für Kinder und JugendheilkundeAuenbruggerplatz 308036 GrazAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Universität Graz LKH-Universitätsklinikum - Eingangsgebäude [Ethikkommission der Medizinischen Universität Graz ]Auenbruggerplatz 2, 3.OGA-8036 GrazAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.meduni-graz.at/ethikkommission/Graz/index.htm
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2008-09-18
- Ethics committee number:
- IRB00002556
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2008-12-18
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- BMC Complementary and Alternative Medicine.2016, 16:12
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry