Trial document
DRKS00004258
Trial Description
Title
The quality of spontaneus movements in preterm infants undergoing craniosacral therapy
Trial Acronym
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URL of the Trial
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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
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00004258
- 2012/07/31
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- yes
- Approved
- IRB00002556, Ethikkommission der Medizinischen Universität Graz
Secondary IDs
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Health Condition or Problem studied
- Preterm
- P07.3 - Other preterm infants
Interventions/Observational Groups
- Preterms (GA<37 Weeks) undergoing craniosacraltherapy for 3 weeks, each intervention for 20 minutes-twice a week
- Preterms (GA<37 Weeks) without craniosacraltherapy
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- investigator/therapist, assessor
- Control group receives no treatment
- Supportive care
- Parallel
- N/A
- N/A
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
Countries of Recruitment
- Austria
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2012/08/01
- 30
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 24 Weeks of pregnancy
- 37 Weeks of pregnancy
Additional Inclusion Criteria
clinical "stable" preterms
Exclusion Criteria
Preterms with cerebral diagnosis
Addresses
-
start of 1:1-Block address primary-sponsor
- Abteilung für Neonatologie Universitätsklinik für Kinder -und Jugendheilkunde
- Mr. Prof. Dr. Berndt Urlesberger
- Auenbruggerplatz 30
- 8036 Graz
- Austria
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +43 316 385-2624
- +43 316 385 2678
- berndt.urlesberger at meduni-graz.at
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Univ. Klinik für Kinder und Jugendheilkunde
- Mr. Dr Wolfgang Raith
- Auenbruggerplatz 30
- 8036 Graz
- Austria
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +43 316 385 80599
- +43 316 385 2678
- wolfgang.raith at klinikum-graz.at
- http://www.neonatologie.com
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Univ. Klinik für Kinder und Jugendheilkunde
- Mr. Dr Wolfgang Raith
- Auenbruggerplatz 30
- 8036 Graz
- Austria
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +43 316 385 80599
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- wolfgang.raith at klinikum-graz.at
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Abteilung für Neonatologie/ Univ.Klinik für Kinder und Jugendheilkunde
- Auenbruggerplatz 30
- 8036 Graz
- Austria
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2015/10/25