Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT06173102
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course
Sponsor:
St. Justine's Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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:
1. Treatment Group: Receiving cranial orthosis therapy initiated one week post their initial physiatrist visit.
2. 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
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:
1. Treatment Group: Receiving cranial orthosis therapy initiated one week post their initial physiatrist visit.
2. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: