Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173102
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-11-30
Brief Title:
Cranial Orthosis Therapy for Plagiocephaly an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course
Sponsor:
St Justines Hospital
Organization:
St Justines Hospital
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:
RECRUITING
Status Verified Date:
2023-12
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:
None
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?:
None