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Plagiocephaly, Nonsynostotic clinical trials

View clinical trials related to Plagiocephaly, Nonsynostotic.

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NCT ID: NCT06173102 Recruiting - Plagiocephaly Clinical Trials

Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course

Start date: December 7, 2023
Phase: N/A
Study type: Interventional

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. The main question it aims to answer are: • Feasibility of conducting the study in our physiatry clinic. Participants will be randomized into two groups, receiving cranial orthosis at 1 week post initial visit, or the standard of care (7 weeks post initial visit). They will have head measurements and helmet adjustments as well as medical follow-up with a total of 4 visits. Post-treatment questionnaires will be filled out.

NCT ID: NCT05917678 Recruiting - Torticollis Clinical Trials

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Start date: May 23, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05848895 Recruiting - Plagiocephaly Clinical Trials

OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

OPT-IN
Start date: October 26, 2023
Phase: N/A
Study type: Interventional

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: 1. Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry. 2. 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 = 122 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 61 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.

NCT ID: NCT05154175 Completed - Clinical trials for Plagiocephaly, Nonsynostotic

Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both

Start date: November 15, 2021
Phase:
Study type: Observational

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 both. This research is a retrospective multi-centric study composed of a collection of clinical data from orthotists database and a survey for patient's parents.

NCT ID: NCT04672837 Recruiting - Clinical trials for Congenital Muscular Torticollis

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

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03970395 Completed - Clinical trials for Nonsynostotic Plagiocephaly

Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03659032 Completed - Plagiocephaly Clinical Trials

Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03430739 Not yet recruiting - Clinical trials for Non Synostotic Plagiocephaly

Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

Start date: June 5, 2018
Phase: N/A
Study type: Observational

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.

NCT ID: NCT03184441 Completed - Plagiocephaly Clinical Trials

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

Start date: June 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02607969 Not yet recruiting - Clinical trials for Deformational Plagiocephaly

Investigating the Effectiveness of Control Frequency on and Deformational Plagiocephaly

Start date: November 2015
Phase: N/A
Study type: Interventional

30 babies with Deformational Plagiocephaly (DP) due to the congenital muscular torticollis will be the participants of the study. The subjects will randomly allocated into the two home program groups; first home program group was seen once every six weeks (SxW), second home program group was seen once a week (OW). Parents will educate about the same home program which consisted of positioning the neck and head, sleep in alternating head positions and in side-laying to increase head shape symmetry and place infants, when awake and under supervision, regularly in the prone position a day to stimulate normal motor development (tummy time), decreasing the time spent in car seat at supine position. Environmental settings also will be given to challenge the baby look through from the side no flattening to room, place colorful and sonorous toys or mirror on the opposite of the flattening side, and stimulate active rotation by communicating with baby from this side. Handling strategies, stretching and strengthening exercises will be given for CMT. The parents will be reinforme if necessary. Positioning strategies will spread throughout the day.Plagiocephaly severity assessment scale (PSS) which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry will be used to evaluate severity of DP.