Clinical trials: Plagiocephaly
Premature Newborns, Cranial Asymmetry
Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
Deformational plagiocephaly is an alteration in the shape of a baby's head caused by pressure exerted on the skull. This condition can begin during gestation and worsen after birth, especially when the baby spends a lot of time…
- Trial name
- plagiocephaly (NCT07758426)
- Testing
- Tummy Time Protocol
- Where
- Brazil
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Hospital de Clinicas de Porto Alegre
Plagiocephaly, Cranial Defect
Associations of Cranial Outcomes and Parental Expectations and Satisfaction
This study aims to investigate the association between objective cranial morphological changes and parental expectations and satisfaction in infants undergoing treatment with a cranial remolding orthosis (CRO).
- Conditions
- Plagiocephaly, Cranial Defect, Orthosis, Expectancy
- Trial name
- NCT07356401
- Testing
- Cranial orthosis
- Where
- Turkey (Türkiye)
- Volunteers
- 10 people
- Sponsor
- Gulhane School of Medicine
Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of…
- Conditions
- Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Brachycephaly, Torticollis
- Trial name
- NCT05917678
- Testing
- Repositioning Therapy, Cranial Remolding Orthosis
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Plagiocephaly, Brachycephaly
Monitoring System for Cranial Orthoses
This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).
- Conditions
- Plagiocephaly, Brachycephaly, Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
- Trial name
- NCT06425172
- Testing
- Cranial Remolding Orthosis
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Texas Southwestern Medical Center
Plagiocephaly, Nonsynostotic, Brachycephaly
Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
The purpose of the study is to examine how cranial helmet therapy may affect neck movement and body temperature regulation in children with positional head deformity.
- Trial name
- NCT07201324
- Testing
- cranial helmet therapy - observational
- Volunteers
- 270 people
- Sponsor
- Wroclaw University of Health and Sport Sciences
Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional
OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational…
- Conditions
- Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Plagiocephaly, Cranium; Deformity
- Trial name
- OPT-IN (NCT05848895)
- Testing
- Osteopathic Manipulative Treatment, Standard of Care Repositioning
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- Osteopathy's Promise to Children
Plagiocephaly, Nonsynostotic
Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market
- Trial name
- NCT06831513
- Testing
- Serkel 3D CRO
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Non Synostotic Plagiocephaly
Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.
The aim of this study is to verify the growth of cranial circumference in children treated with helmets for positional skull deformity.
- Trial name
- PCPlagio (NCT06956768)
- Volunteers
- 150 people
- Sponsor
- Central Hospital, Nancy, France
Plagiocephaly, Plagiocephaly, Nonsynostotic
Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course
Our study aims to assess the feasibility of a randomized controlled trial that investigates the efficacy of cranial orthosis therapy for treating severe deformational plagiocephaly in infants between 4 and 7 months old.
- Conditions
- Plagiocephaly, Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional
- Trial name
- NCT06173102
- Testing
- Cranial Orthosis
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- St. Justine's Hospital
Plagiocephaly, Brachycephaly
Cranial Remolding Orthosis Registry
A registry of infants fitted with a cranial remolding orthosis.
- Conditions
- Plagiocephaly, Brachycephaly, Asymmetric Head
- Trial name
- NCT06762691
- Testing
- MyCRO Band, Traditional CRO
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Otto Bock HealthCare LP
Plagiocephaly
Newborn Head Molding and Later Asymmetries
Prospective randomized clinical interventional trial after birth in maternity ward, and follow up to 8-9 years of age. Hypothesis: Preventive handling and caring advices to parents of newborns decrease craniofacial asymmetries…
- Trial name
- NCT02283229
- Testing
- Newborns with preventive caring advices, Newborns with normal caring advices
- Where
- Finland
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- University of Oulu
Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional
Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
This study evaluates the efficacy of Pediatric Integrative Manual Therapy in the treatment of positional plagiocephaly in infants.
- Conditions
- Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Congenital Muscular Torticollis
- Trial name
- NCT04672837
- Testing
- Pediatric Integrative Manual Therapy and educational therapy, Stretching and educational therapy
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Universidad de Zaragoza
Plagiocephaly, Positional, Plagiocephaly, Nonsynostotic
Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both
The objective of the research is to measure the effectiveness of the Ottobock helmet, an innovative 3D-printed cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of…
- Conditions
- Plagiocephaly, Positional, Plagiocephaly, Nonsynostotic, Brachycephaly
- Trial name
- NCT05154175
- Testing
- Ottobock helmet
- Where
- 12 sites in France
- Volunteers
- 452 people
- Sponsor
- Otto Bock France SNC
Plagiocephaly, Nonsynostotic
Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial
This study evaluates the effectiveness of repositioning techniques and neck stretching exercises in comparison to cranial orthotic devices (COD) in correcting plagiocephaly in infants.
- Trial name
- CRANIO (NCT02370901)
- Testing
- Helmet, home therapies
- Where
- United States
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- Pat Ricalde,DDS, MD, FACS
Development, Infant, IMAGE
3D Craniofacial Morphologic Development of Healthy Infants
Healthy infants were enrolled to receive three dimensional craniofacial photography regularly at their age of one month, two month, four month, six month, nine month and twelve month.
- Conditions
- Development, Infant, IMAGE, Craniofacial Asymmetry, Plagiocephaly
- Trial name
- NCT05004597
- Testing
- three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)
- Where
- Taiwan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Nonsynostotic Plagiocephaly
Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
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.
- Trial name
- NCT03970395
- Testing
- Osteopathic manipulative therapy (OMTh), Light Touch Therapy (LTT), Repositioning therapy
- Where
- Italy
- Volunteers
- 96 people
- Sponsor
- PRIOLO CLAUDIO
Nonsynostotic Plagiocephaly
Brain Characteristics Noted Prior to and Following Treatment
This study will enable investigators to find out if brain structure and characteristics are affected by the shape of the infant's head, and if changes in the brain occur with helmet therapy.
- Trial name
- NCT02392195
- Testing
- Non-interventional
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Congenital Torticollis, Positionnel Skull Deformation
3D Characterisation of the Skull Base Deformation in Congenital Muscular Torticollis
The congenital muscular torticollis (CMT) is defined by an abnormal posture of the head and the neck compared to shoulders' level of the newborn.
- Trial name
- NCT04421898
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Montpellier
Plagiocephaly, Plagiocephaly, Nonsynostotic
Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly
This study evaluates the efficacy of Pediatric Manual Therapy in the treatment of positional plagiocephaly in infants. 40 participants will receive a protocol of Pediatric Manual Therapy and educational physiotherapy in…
- Conditions
- Plagiocephaly, Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional
- Trial name
- NCT03659032
- Testing
- Pediatric Manual Therapy, Educational Physical Therapy
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidad de Zaragoza
Plagiocephaly
Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing < 1…
- Trial name
- NCT03184441
- Testing
- Premie Pouch
- Where
- 3 sites in United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital