What development deficits and problems or diagnoses do children have that require helmet therapy in infancy when the skull is deformed due to position

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021488

Enrollment

Registered

2020-09-14

Start date

2020-07-24

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 Q67.4

Interventions

Group 1: Group 1: Former helmet therapy patients A questionnaire is used to ask specific questions about certain diagnoses (e.g. visual/hearing impairment, developmental delays or disorders that req

Eligibility

Sex/Gender

All

Age

0 Years to 18 Years

Inclusion criteria

Inclusion criteria: - Former "helmet wearers", of whom complete data sets from the helmet therapy of that time (in infancy / from the years 2012 and 2013) are available - Helmet children : at primary school age of approx. 6-8 years - Siblings of all ages

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
The primary question is whether former head prosthesis wearers have a higher risk of special developmental features (in the broadest sense "complications") than children who did not require an orthosis. To this end, families whose children have received "helmet therapy" should receive a one-time questionnaire and answer questions about the health of the patient and his or her siblings. The questionnaire is based on a study that reports that children with head deformities have more complications later in life than their siblings (Miller and Clarren). A questionnaire is used to ask specific questions about certain diagnoses (e.g., visual/hearing impairment, developmental delays or disorders that require certain forms of therapy, including speech therapy, physiotherapy or occupational therapy). However, not only diagnoses are to be queried, but also connections to certain medical specialties, the use of aids such as glasses, hearing aids or orthoses, as well as gross and fine motor skills such as the use of a pen and scissors.	—

Measure

Time frame

The primary question is whether former head prosthesis wearers have a higher risk of special developmental features (in the broadest sense "complications") than children who did not require an orthosis. To this end, families whose children have received "helmet therapy" should receive a one-time questionnaire and answer questions about the health of the patient and his or her siblings. The questionnaire is based on a study that reports that children with head deformities have more complications later in life than their siblings (Miller and Clarren). A questionnaire is used to ask specific questions about certain diagnoses (e.g., visual/hearing impairment, developmental delays or disorders that require certain forms of therapy, including speech therapy, physiotherapy or occupational therapy). However, not only diagnoses are to be queried, but also connections to certain medical specialties, the use of aids such as glasses, hearing aids or orthoses, as well as gross and fine motor skills such as the use of a pen and scissors.

—

Secondary

Measure	Time frame
-Comparison Proportion of children with complications between helmet patients and siblings using a chi-square test (primary comparison) -secondary comparison: comparison at family level: creation of two variables "helmet child has complications (yes/no)" and "at least one sibling has complications (yes/no)	—

Countries

Germany

Contacts

Public ContactYvonne Noll

Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift, Leitung Klinisches Studienmanagement

yvonne.noll@diakovere.de0511-5354-649

Outcome results

None listed

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