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The effectiveness of a single osteopathic intervention with decussation of the guardians on the problem of positional plagiocephaly. A randomized controlled trial.

The effectiveness of a single osteopathic intervention with decussation of the guardians on the problem of positional plagiocephaly. A randomized controlled trial. - EOIDPP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034303
Enrollment
30
Registered
2024-05-21
Start date
2024-05-22
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q67.3

Interventions

Group 1: Osteopathic intervention with information about handling, positioning and handling a baby with skull asymmetry (1x 30 min. explanation and then 1x 30 min. treatment) Group 2: Control group wi

Sponsors

therapie.fit
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Weeks to 4 Months

Inclusion criteria

Inclusion criteria: - the existence of a position-related skull asymmetry (diagnosis made by the treating pediatrician) - Age between four and 14 weeks old - U3 prevention completed - already informed by the pediatrician about the correct handling within the standardized scope of preventive care - the child is healthy and has no known or previous history of any other illnesses (e.g. heart disease, respiratory distress syndrome) - age-appropriate development - CI less than 100 at baseline - CVAI less than 11 at baseline - Girls and boys in a ratio of 1:1 - The parents of the test subjects understand spoken and written German or have a translator - Legal guardians provide written consent for the study

Exclusion criteria

Exclusion criteria: - The cause of the skull deformity is not positional - known illnesses - CI over 100 at the start of the study (If the value is over 100, therapy using a helmet will be considered first, as it is a severe asymmetry that does not show any demonstrable and satisfactory improvements through purely manual techniques and positioning (Grasl C., 2022 These subjects are therefore excluded from the study.) - CVAI over 11 at the start of the study (If the value is over 11, treatment using a helmet will be considered first, as this is a severe asymmetry that does not show any demonstrable and satisfactory improvements through purely manual techniques and positioning (Grasl C., 2022 These subjects are therefore excluded from the study.) - Stay in the intensive care unit after birth - current physiotherapy, manual therapy, occupational therapy or similar - current care using a helmet - making the treatment impossible because the child cannot be treated under any circumstances, in any position or with any help (breastfeeding, swaying, music) and only screams

Design outcomes

Primary

MeasureTime frame
Skull asymmetry is measured using the Scully Care app to measure CVAI (nose-occiput line) and CI (ear-to-ear distance). Determined before the explanation for all participants (measurement 1) and after 10-14 days (measurement 2). A group is measured on day 1 (5 - 10 minutes), then educated (30 minutes) and treated (30 minutes). The control group is measured (5-10 min.) and informed (30 min.) on day 1. After 10-14 days, all participants (group and control group) are measured again (measurement 2).

Countries

Germany

Contacts

Public ContactMichaela Mahlow

therapie fit

info@therapie.fit4917631285956

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026