Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02370901 |
| Other study ID # |
Plagiocephaly |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 6, 2017 |
| Est. completion date |
November 6, 2022 |
Study information
| Verified date |
November 2021 |
| Source |
University of South Florida |
| Contact |
Pat Ricalde, MD,DDS,FACS |
| Phone |
813-870-6000 |
| Email |
ricalde[@]flcranio.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
