Onderzoek naar de effecten van helmbehandeling van kinderen van 5 maanden met een schedelvervorming.

Recruiting

• Conditions: plagiocephaly, brachycephaly, skull deformation, helmet therapy, positional preference; schedelvervorming, plagioceflaie, brachycefalie, helmbehandleing, voorkeurshouding

• Registration Number: NL-OMON25572
• Lead Sponsor: niversity of Twente

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1. Children 5 months of age, either sex;

2. Moderate to severe DP:

Exclusion Criteria

1. Premature children;

2. Children with congenital muscular torticollis;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symmetry of the skull at 8, 12, and 24 months, measured by plagiocephalometry (PCM).

Secondary Outcome Measures

Name	Time	Method
Main study:<br /><br>1. Subjective outcome score (at 5, 12, 24 months);<br /><br>2. (Psycho)motor development (at 5, 12 and 24 months) (AIMS, Van Wiechen, ASQ);<br /><br>3. Quality of life (at 2 years);<br /><br>4. Parental attitudes (at 5, 12 and 24 months);<br /><br>5. Parental anxiety level and parental concerns (at 5, 12 and 24 months) (STAI);<br /><br>6. Satisfaction with the treatment (at 12 and 24 months). <br><br /><br /><br>Secondary outcome of the ancillary methods study:<br /><br>1. Decisional conflict scale;<br /><br>2. Actual preference for treatment (helmet, wait-and-see, randomised controlled trial [RCT]);<br /><br>3. Stated preference for treatment.