search

Active clinical trials for "Plagiocephaly"

Results 1-10 of 18

Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the...

PlagiocephalyNonsynostotic

This study evaluates the effectiveness of repositioning techniques and neck stretching exercises in comparison to cranial orthotic devices (COD) in correcting plagiocephaly in infants.

Recruiting4 enrollment criteria

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Deformational PlagiocephalyDeformational Posterior Plagiocephaly3 more

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 deformational head shapes. Infants with torticollis will be concurrently enrolled in physical therapy treatment until the torticollis is resolved. A normal, unaffected population will be studied to compare typical growth to the growth of infants undergoing active treatment.

Recruiting4 enrollment criteria

Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular...

PlagiocephalyNonsynostotic3 more

This study evaluates the efficacy of Pediatric Integrative Manual Therapy in the treatment of positional plagiocephaly in infants. 25 participants will receive a protocol of Pediatric Integrative Manual Therapy and educational physiotherapy in combination, while the other 25 will receive a stretching protocol and educational physiotherapy

Recruiting6 enrollment criteria

OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

PlagiocephalyNonsynostotic4 more

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 plagiocephaly. The main hypothesis is that children who received OMT will show significantly improved anthropometric measures of cranial symmetry over those receiving the current pediatric standard of care of repositioning. This is a two-arm, randomized cross-over clinical trial. With parental consent, pediatric patients (infants <4 months of age) will be organized into one of two groups: Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry. Those who receive standard care only with repositioning attention from the parents After 8-weeks of being in the first group, each participant will cross-over into the second group (OMT or repositioning) N = 50 subjects diagnosed with deformational plagiocephaly (DP) are to be recruited (to allow for natural attrition and loss to follow up) with the recruitment to continue until 25 patients have been placed in each of the two groups and will cross-over to the respective treatment group (OMT and standard of care repositioning therapy). Timeline: It is projected that to recruit and carry out the assessments and interventions (8-weeks of each group with 12-months of follow-up longitudinally), it will require two years (24-months) from the beginning of the study to completion.

Not yet recruiting15 enrollment criteria

Newborn Head Molding and Later Asymmetries

Plagiocephaly

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 (deformational plagiocephaly and torticollis). The minimum sample size of the study was calculated at 86 (43 in each arm) using a 5% significance level, a power of 80% and a fall in the prevalence of DP from 31% to 8%. Craniofacial asymmetries and appearances of occlusal defects are followed up to 9 years. 50 preterm infants can participate without intervention.

Enrolling by invitation6 enrollment criteria

Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU

PlagiocephalyScaphocephaly1 more

Many hospitalized infants can develop a flattening of the back or sides of their head. This condition develops gradually when an infant's head rests on a firm or semi-firm surface for a prolonged period of time. Premature infants are more likely to have a positional head shape deformity because they may spend longer periods of time in a crib. Infants participating in this study will be randomly assigned to either standard treatment, which is a moldable positioner device, or to a cranial cup device and moldable positioner for positioning. The purpose of this prospective single-blinded randomized clinical trial will be to evaluate the effectiveness of the cranial cup in preventing positional head shape deformity in the NICU patient population.

Terminated11 enrollment criteria

Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

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.

Completed8 enrollment criteria

Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

PlagiocephalyPlagiocephaly3 more

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 combination, while the other 20 will receive only educational physiotherapy

Completed6 enrollment criteria

Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants

Plagiocephaly

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 kilogram.

Completed11 enrollment criteria

Preventive Osteopathic Treatment of Plagiocephaly

Positilonal Deformation of the SkullHead Turn Preference1 more

Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. The High Authority for Health (HAS) will soon put in place recommendations with a fact sheet for health professionals and the public. The aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull. The main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk. the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months. Methodology: Controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18 months and the follow-up period is 4 months. Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and stimulation advice. The perspectives are: the decrease in the prevalence of CPP after early osteopathic treatment. Defining a decision algorithm for early osteopathic treatment. Subject to recommendations on the indication of early osteopathic treatment in neonates at risk.

Completed16 enrollment criteria
12

Need Help? Contact our team!


We'll reach out to this number within 24 hrs