Trial document




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  DRKS00004258

Trial Description

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Title

The quality of spontaneus movements in preterm infants undergoing craniosacral therapy

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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.

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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

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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
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Secondary IDs

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Health Condition or Problem studied

  •   Preterm
  •   P07.3 -  Other preterm infants
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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
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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
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Primary Outcome

Quality of the General Movements in preterms undergoing craniosacraltherapy
Scoring: General Motor Optimaltity Score
measured-15 min before and after the Intervention

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Secondary Outcome

Weight differencs in preterms undergoing craniosacral therapy-before the first and after the last intervention

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/08/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   24   Weeks of pregnancy
  •   37   Weeks of pregnancy
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Additional Inclusion Criteria

clinical "stable" preterms

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Exclusion Criteria

Preterms with cerebral diagnosis

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Addresses

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    • Abteilung für Neonatologie Universitätsklinik für Kinder -und Jugendheilkunde
    • Mr.  Prof. Dr.  Berndt  Urlesberger 
    • Auenbruggerplatz 30
    • 8036   Graz
    • Austria
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    • Univ. Klinik für Kinder und Jugendheilkunde
    • Mr.  Dr  Wolfgang  Raith 
    • Auenbruggerplatz 30
    • 8036  Graz
    • Austria
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    • Univ. Klinik für Kinder und Jugendheilkunde
    • Mr.  Dr  Wolfgang  Raith 
    • Auenbruggerplatz 30
    • 8036  Graz
    • Austria
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Sources of Monetary or Material Support

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    • Abteilung für Neonatologie/ Univ.Klinik für Kinder und Jugendheilkunde
    • Auenbruggerplatz 30
    • 8036  Graz
    • Austria
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Status

  •   Recruiting complete, follow-up complete
  •   2015/10/25
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Trial Publications, Results and other Documents

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