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Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial (CRANIO)

Primary Purpose

Plagiocephaly, Nonsynostotic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helmet
home therapies
Sponsored by
Pat Ricalde,DDS, MD, FACS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plagiocephaly, Nonsynostotic

Eligibility Criteria

4 Months - 7 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children diagnosed with deformational molding (CVA greater than 6mm, CI > 90%, or mixed)

Exclusion Criteria:

  • Children younger than 4 months and older than 7 months
  • Children with plagiocephaly due to craniosynostosis, neoplasm, vertebral, or hydrocephalus.
  • Scaphocephaly

Sites / Locations

  • The Florida Craniofacial InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Helmet

home therapies

Arm Description

Patients will be referred to a cranial orthotist who will create a custom cranial orthotic device. They will undergo adjustments monthly. At these appointments anthropometric measurements will be done by the cranial orthotist. The orthotist will be blinded and will not be informed of which patient is involved in the study.

Patients will be referred to a physical therapist. They will be offered education, neck stretching exercises, and repositioning techniques, and reassurance.

Outcomes

Primary Outcome Measures

Effectiveness of helmet versus repositioning techniques for treatment of deformational molding (CVA must be less than or equal to (x-5)/2 and/or CI must be less than or equal to (x-89)/2)
CVA must be less than or equal to (x-5)/2 and/or CI must be less than or equal to (x-89)/2

Secondary Outcome Measures

Parent satisfaction
questionnaire will be administered at 6, 12, 24 months
Impression of skull deformity
questionnaire will be administered

Full Information

First Posted
February 5, 2015
Last Updated
November 3, 2021
Sponsor
Pat Ricalde,DDS, MD, FACS
Collaborators
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02370901
Brief Title
Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial
Acronym
CRANIO
Official Title
Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
November 6, 2022 (Anticipated)
Study Completion Date
November 6, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pat Ricalde,DDS, MD, FACS
Collaborators
University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effectiveness of repositioning techniques and neck stretching exercises in comparison to cranial orthotic devices (COD) in correcting plagiocephaly in infants.
Detailed Description
This is a prospective randomized controlled trial with the goal of recruiting 226 participants. The participants will be between the ages of 4-7 months and will be randomized into two groups: Treatment group A, which will provide treatment using cranial orthotic devices (CODs) ; and Treatment group B, which will provide treatment using repositional techniques and neck stretching exercises. These participants will be offered enrollment if they have deformational molding with CVA greater than 6 mm and/or CI> 90%. Asymmetric plagiocephaly is defined by cranial vault index (CVA). CVA is the difference between two diagonal cranial diameters (CVA= Longer diagonal-shorter diagonal). Cranial diameters are measured from orbitale superius suture to orbitale superius rear (see Appendix 1). Normal CVA is <6mm, mild CVA is 6-10mm, moderate CVA is 11-15mm, and severe CVA is >15mm. Brachycephaly is defined by the cephalic index (CI). This measurement is the width/length of cranium x100. Length of cranium is measured from glabella to opisthocranion and width is measured from eurion to eurion. Normal CI is 75-90%, mild brachycephaly is 90.1-95%, moderate brachycephaly is 95.1-100%, severe brachycephaly is >100%. Currently, repositioning exercises and helmeting therapy are both options given to the parents as there is no consensus on preferred standard of care. Once the parents have made the decision, the study investigators will monitor the patient and change therapy if there is no response to treatment or if the parents decide they would like to change therapies. The randomization will be conducted by using a system created by the USF Department of Biostatistics. It involves a covariate adaptive randomization so that the patients will continue to be randomized throughout the trial but still allowing for covariates. Covariates for this study will be : type of deformity - Isolated plagiocephaly (CVA >6; 75 < CI < 90), isolated brachycephaly (CVA<6; CI > 90), and mixed brachy/ plagiocephaly (CVA > 6; CI > 90) severity of deformity - a CVA of 10 mm would be compared to another CVA of 10mm Once families consent for their child to be a participant, basic demographic information will be collected. Study investigators will also collect data on developmental delay. Participants will be randomized by the physician to ensure appropriate grouping into each of the above mentioned covariates. The participants'' families will subsequently be notified the same day of the results of randomization into Treatment Group A or Treatment Group B. Both treatments are currently equally used in plagiocephaly, so there is no harm to the patient in being selected for one group versus another. The physician will re-evaluate the patients at 3 months, and if no progress is made , or if the parents are unhappy with the randomized form of treatment, the parents will have the option of switching to another group. Potential adverse outcomes of the treatments themselves are listed as follows: Treatment Group A (Cranial Orthotic Devices): Skin irritation due to helmeting Treatment Group B: Pain caused by inappropriate technique in exercises Study consent forms will include these and any other potential adverse outcomes, with a direct line to our office for notification. Benefits include correction of the plagiocephaly, and will be explained to the parents as the goal of treatment. All adverse outcomes will be reported to the IRB. Of note, these outcomes have yet to be witnessed by our staff despite years of treating patients with these methods. Once randomized and selected, Treatment Group A will be fitted for CODs and will undergo monthly adjustments by a licensed cranial orthotist at West Coast Brace and Limb. This is standard of care for plagiocephaly. Monitoring of the patient's use of the helmet will be the responsibility of the parents, with goal of treatment to be 23 hours per day. The orthotist will have no knowledge of whether patients are enrolled in the study versus not, and will be conducting the normal responsibilities for their job. Data that is collected will be the same for all patients regardless of study enrollment. The principal study investigator, Dr. Ricalde, will be the only person with knowledge and access to the data collection for study patients during these visits. Treatment Group B will be asked appropriate questionnaires by FCI staff and be encouraged to perform at-home repositioning techniques and neck stretching exercises. If the patient has any concerns they will be asked to come in for evaluation by a licensed physical therapist. This is the standard of care for plagiocephaly. The physical therapist will have no knowledge of whether patients are enrolled in the study versus not, and will be conducting the normal responsibilities for their job. Data that is collected will be the same for all patients regardless of study enrollment. Dr. Ricalde will be the only person with knowledge and access to the data collection for study patients during these visits. The physical therapist and the orthotist will both be blinded to study participants, but true blinding of the treatment is not possible as the treatments require some knowledge by the parents. Initially, data will include a health questionnaire to screen for sex and developmental delay , as well as having initial CVA and CI measurements via STAR Scanner device, a standard device used by orthotists using laser light that has no harmful effects to the patient. In addition to initial measurements, patients will have measurements taken monthly (CVA and CI) by the cranial orthotist. All patients will receive photos, Star Scanner measurements, and questionnaires A and C at 6, 12, 24 months to evaluate treatment progression. Questionnaires will be administered to parents to assess satisfaction at 6, 12, 24 months. The option to switch treatment will be conducted at 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plagiocephaly, Nonsynostotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Helmet
Arm Type
Experimental
Arm Description
Patients will be referred to a cranial orthotist who will create a custom cranial orthotic device. They will undergo adjustments monthly. At these appointments anthropometric measurements will be done by the cranial orthotist. The orthotist will be blinded and will not be informed of which patient is involved in the study.
Arm Title
home therapies
Arm Type
Experimental
Arm Description
Patients will be referred to a physical therapist. They will be offered education, neck stretching exercises, and repositioning techniques, and reassurance.
Intervention Type
Device
Intervention Name(s)
Helmet
Other Intervention Name(s)
Cranial Orthotic Device, Starband
Intervention Description
Custom fitting helmet, FDA approved, to allow reshaping of the infant skull
Intervention Type
Behavioral
Intervention Name(s)
home therapies
Other Intervention Name(s)
NSE/ RPT
Intervention Description
parents will be instructed to do home neck stretching exercises, as well as repositioning techniques to keep baby off the flat spot. They will also be offered reassurance.
Primary Outcome Measure Information:
Title
Effectiveness of helmet versus repositioning techniques for treatment of deformational molding (CVA must be less than or equal to (x-5)/2 and/or CI must be less than or equal to (x-89)/2)
Description
CVA must be less than or equal to (x-5)/2 and/or CI must be less than or equal to (x-89)/2
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Parent satisfaction
Description
questionnaire will be administered at 6, 12, 24 months
Time Frame
12 months
Title
Impression of skull deformity
Description
questionnaire will be administered
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children diagnosed with deformational molding (CVA greater than 6mm, CI > 90%, or mixed) Exclusion Criteria: Children younger than 4 months and older than 7 months Children with plagiocephaly due to craniosynostosis, neoplasm, vertebral, or hydrocephalus. Scaphocephaly
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pat Ricalde, MD,DDS,FACS
Phone
813-870-6000
Email
ricalde@flcranio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pat Ricalde, MD,DDS,FACS
Organizational Affiliation
Florida Craniofacial Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Florida Craniofacial Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pat Ricalde, MD, DDS
Phone
813-870-6000
Email
ricalde@flcranio.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22776627
Citation
van Wijk RM, Boere-Boonekamp MM, Groothuis-Oudshoorn CG, van Vlimmeren LA, IJzerman MJ. HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial. Trials. 2012 Jul 9;13:108. doi: 10.1186/1745-6215-13-108.
Results Reference
result

Learn more about this trial

Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial

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