Investigating the Optimal Usage Time of Helmet in Babies With Deformational Plagiocephaly
| Registry | NCT03430739 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 28 (Estimated) |
| Sponsor | Hacettepe University (Other) |
| Conditions | Non Synostotic Plagiocephaly |
| Interventions | No intervention (Other) |
| Dates | start 2018-06-05 (estimated), primary completion 2019-06-05 (estimated), completion 2019-07-05 (estimated), first posted 2018-02-13, last updated 2018-02-13 |
| Locations | 1 site in Turkey (Türkiye) |
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Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months.
Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months. After the follow period completed, participants will be allocated two groups; avarage using 15-18 hours a day and avarage using 19-23 hours a day. Results will be compared for the two groups and correlation between the time of usage and cranial symmetry will be compare.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Babies; Usage time of Helmet between 15-18 hours a day | Other: No intervention | Babies who worn the helmet for 15-18 hours a day | |
| Babies; Usage time of Helmet between 19-23 hours a day | Other: No intervention | Babies who worn the helmet for 19-23 hours a day |
Sex: All, ages: 1 Day to 7 Months
Inclusion Criteria: have deformational plagiocephaly consent from caregivers age between 1 day to 7 months Exclusion Criteria: have another systemic, neurologic or orthopedic problem
| Facility | City | Country | Status |
|---|---|---|---|
| Trakya University | Edirne | Turkey (Türkiye) |