Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-03 @ 7:23 PM
Study NCT ID:
NCT03970395
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2019-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Sponsor:
PRIOLO CLAUDIO
Organization:
Study Overview
Official Title:
Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.
Detailed Description:
Nonsynostotic plagiocephaly (NSP) is defined as the deformation of the head resulting from external forces that mould the skull during the first months of life.
Four months seems to be a critical age for the development of NSP, but many positional head shape deformities may improve with time.
Early assessment and diagnosis is important not only for the shape of the skull, but also for possible clinical significant differences in gross motor development.
In paediatric conditions the effect of osteopathic manipulative treatment is documented in systematic reviews; in NSP the only study, which is a pilot, reveals an average reduction of 50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.
Four months seems to be a critical age for the development of NSP, but many positional head shape deformities may improve with time.
Early assessment and diagnosis is important not only for the shape of the skull, but also for possible clinical significant differences in gross motor development.
In paediatric conditions the effect of osteopathic manipulative treatment is documented in systematic reviews; in NSP the only study, which is a pilot, reveals an average reduction of 50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: