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

Not Applicable

Recruiting

Conditions: Q67.3
Plagiocephaly

Registration Number: DRKS00034303

Lead Sponsor: therapie.fit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

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

- 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures