PlagiocephalyNCT06173102
Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course
A study testing Cranial Orthosis in people with Plagiocephaly and Plagiocephaly, Nonsynostotic, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 122 to 212 days
- Conditions the study is for
- Plagiocephaly, Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional
- What is being tested?
- Cranial Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 7 Dec 2023to 9 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 122 to 212 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All participants must be assessed by a physiatrist at Sainte-Justine Hospital at the plagiocephaly clinic of the physical medicine and rehabilitation service.
- Participants must have a clinical diagnosis of severe deformational plagiocephaly by a physiatrist based on clinical evaluation and confirmed by anthropometric measurements with a spreading caliper and 3D-scan.
- Participants must be aged from 4 months and 0 days to 7 months old minus a day at the onset of cranial orthosis therapy. Premature subjects will be age-adjusted by calculating the post-partum age minus the number of weeks of prematurity, rounding to the whole nearest month.
- Participants' parents (or legal guardian) must be apt to give consent and able to reliably express themselves (either written or verbally, if illiterate or unable to write for any other reason).
Who cannot join
- Patients whose 3D-scan measurements do not confirm a severe plagiocephaly.
- Participants who are lost at follow-up or who drop out of treatment will be excluded.
- Participants whose parents report less than 20 hours per day on average of helmet wear.
- Participants with synostotic cranial deformation.
- Patients with isolated brachycephaly, without a plagiocephalic component to the deformation.
- Patients with other craniofacial deformities or syndromes.
- Patients having had their orthosis made or modified at a laboratory other than the Sainte-Justine hospital/Centre de réadaptation Marie-Enfant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Effectiveness of Cranial Orthosis Therapy in the Correction of Deformational Plagiocephaly: a Randomized Controlled Pilot Study Comparing Cranial Orthosis Therapy 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.
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.
Read the detailed description
Our research endeavors to examine the feasibility of implementing a randomized controlled trial (RCT) that evaluates the efficacy of cranial orthosis therapy in addressing severe deformational plagiocephaly among infants aged 4 to 7 months.
Primary Objective: The central focus is on evaluating the feasibility aspects associated with the RCT design within our clinical setting.
Participants: Infants meeting the inclusion criteria will be recruited and randomized into two distinct groups:
- Treatment Group: Receiving cranial orthosis therapy initiated one week post their initial physiatrist visit.
- Control Group: Adhering to the standard of care, with cranial orthosis initiation at 7 weeks post their initial physiatrist visit.
Study Procedures: Participants in both groups will undergo a structured series of assessments and interventions, including:
- Head measurements and 3D-scan evaluations to quantify cranial deformities.
- Helmet adjustments by experienced orthotists based on growth and changes in head shape.
- Regular medical follow-ups, totaling four visits during the course of the study.
Post-Treatment Assessments: Upon completion of the cranial orthosis therapy, participants will be required to fill out post-treatment questionnaires, providing valuable insights into their experiences, satisfaction levels, and any potential concerns
- Being tested
- Cranial Orthosis
- Medical subject headings
- Plagiocephaly, Plagiocephaly, Nonsynostotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial OrthosisDevice
Early versus usual reception of orthosis.
| Study group | Role | What they receive |
|---|---|---|
| Early Cranial Orthosis | Experimental | Early cranial orthosis (reception 1 week after initial visit) Receives: Device: Cranial Orthosis |
| Usual Cranial Orthosis | Other | Usual cranial orthosis (reception 7 weeks after initial visit) Receives: Device: Cranial Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative information on Feasibility
documenting difficulties encountered during the pilot study, including but not limited to loss at follow-up, missed appointments, missing questionnaires, difficulties with enrollment, and coordination of appointments between the PM\&R service and the Orthotics clinic.
Measured: through study completion, average of 12 weeks per patient
Secondary outcomes (4)
Cranial Vault Asymmetry (CVA)
The difference between the longest and shortest cranial diagonals, measured in millimeters.
Measured: at week 0, week 6 and week 12
Cranial Vault Asymmetry Index (CVAI)
A percentage value that considers the overall size of the head in relation to CVA.
Measured: at week 0, week 6 and week 12
Parental Satisfaction:
Measured with a parental questionnaire at the end of treatment, assessing satisfaction with head shape and cranial orthosis therapy.
Measured: through completion of study, on average 12 weeks per patient
Adverse Effects:
Any adverse effects observed during cranial orthosis therapy will be collected from parental questionnaires and medical chart records.
Measured: through completion of study, on average 12 weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start7 Dec 2023
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlagiocephalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomization sequence will be created using Microsoft Excel 2022 with a 1:1 allocation using random block sizes of 2 and
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camille Costa, St. Justine's Hospital
- Investigators
- Camille Costa, MD, Principal investigator, Université de Montréal, CHU Sainte-Justine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173102
- Sponsor's protocol ID
- 2024-5800
- Status last verified
- Jan 2025
- First submitted
- 30 Nov 2023
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effectiveness of Cranial Orthosis Therapy in the Correction of Deformational Plagiocephaly: a Randomized Controlled Pilot Study Comparing Cranial Orthosis Therapy to the Natural Course
- ClinicalTrials.gov ID
- NCT06173102
- Acronym / sponsor ID
- 2024-5800
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our research endeavors to examine the feasibility of implementing a randomized controlled trial (RCT) that evaluates the efficacy of cranial orthosis therapy in addressing severe deformational plagiocephaly among infants aged 4 to 7 months.
Primary Objective: The central focus is on evaluating the feasibility aspects associated with the RCT design within our clinical setting.
Participants: Infants meeting the inclusion criteria will be recruited and randomized into two distinct groups:
- Treatment Group: Receiving cranial orthosis therapy initiated one week post their initial physiatrist visit.
- Control Group: Adhering to the standard of care, with cranial orthosis initiation at 7 weeks post their initial physiatrist visit.
Study Procedures: Participants in both groups will undergo a structured series of assessments and interventions, including:
- Head measurements and 3D-scan evaluations to quantify cranial deformities.
- Helmet adjustments by experienced orthotists based on growth and changes in head shape.
- Regular medical follow-ups, totaling four visits during the course of the study.
Post-Treatment Assessments: Upon completion of the cranial orthosis therapy, participants will be required to fill out post-treatment questionnaires, providing valuable insights into their experiences, satisfaction levels, and any potential concerns
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomization sequence will be created using Microsoft Excel 2022 with a 1:1 allocation using random block sizes of 2 and
| Arm | Type | Receives |
|---|---|---|
| Early Cranial Orthosis | Experimental | Device: Cranial OrthosisEarly cranial orthosis (reception 1 week after initial visit) |
| Usual Cranial Orthosis | Other | Device: Cranial OrthosisUsual cranial orthosis (reception 7 weeks after initial visit) |
Who may qualify
- Ages
- 122 to 212 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All participants must be assessed by a physiatrist at Sainte-Justine Hospital at the plagiocephaly clinic of the physical medicine and rehabilitation service.
- Participants must have a clinical diagnosis of severe deformational plagiocephaly by a physiatrist based on clinical evaluation and confirmed by anthropometric measurements with a spreading caliper and 3D-scan.
- Participants must be aged from 4 months and 0 days to 7 months old minus a day at the onset of cranial orthosis therapy. Premature subjects will be age-adjusted by calculating the post-partum age minus the number of weeks of prematurity, rounding to the whole nearest month.
- Participants' parents (or legal guardian) must be apt to give consent and able to reliably express themselves (either written or verbally, if illiterate or unable to write for any other reason).
Key exclusion criteria (7 listed)
- Patients whose 3D-scan measurements do not confirm a severe plagiocephaly.
- Participants who are lost at follow-up or who drop out of treatment will be excluded.
- Participants whose parents report less than 20 hours per day on average of helmet wear.
- Participants with synostotic cranial deformation.
- Patients with isolated brachycephaly, without a plagiocephalic component to the deformation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial OrthosisEarly versus usual reception of orthosis. | Device | Early Cranial Orthosis, Usual Cranial Orthosis |
Primary outcome
Qualitative information on Feasibility
Time frame: through study completion, average of 12 weeks per patient
documenting difficulties encountered during the pilot study, including but not limited to loss at follow-up, missed appointments, missing questionnaires, difficulties with enrollment, and coordination of appointments between the PM\&R service and the Orthotics clinic.
4 secondary outcomes
Cranial Vault Asymmetry (CVA)
Time frame: at week 0, week 6 and week 12
Cranial Vault Asymmetry Index (CVAI)
Time frame: at week 0, week 6 and week 12
Parental Satisfaction:
Time frame: through completion of study, on average 12 weeks per patient
Adverse Effects:
Time frame: through completion of study, on average 12 weeks per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Plagiocephaly
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Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
Premature Newborns, Cranial Asymmetry
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Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
Not yet recruitingObservational study
Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
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OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
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Not yet recruitingObservational study
Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.
Non Synostotic Plagiocephaly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille Costa, MD principal investigator
Université de Montréal, CHU Sainte-Justine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Orthosis in people with Plagiocephaly and Plagiocephaly, Nonsynostotic, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative information on Feasibility (time frame: through study completion, average of 12 weeks per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.