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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Qualitative information on Feasibility
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 122 Days 至 212 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Qualitative information on Feasibility
时间窗: 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.
次要结局
- Cranial Vault Asymmetry (CVA)(at week 0, week 6 and week 12)
- Cranial Vault Asymmetry Index (CVAI)(at week 0, week 6 and week 12)
- Parental Satisfaction:(through completion of study, on average 12 weeks per patient)
- Adverse Effects:(through completion of study, on average 12 weeks per patient)
研究者
Camille Costa
Associate Researcher
St. Justine's Hospital