The Feasibility and Acceptability of 3D Printed Orthotics in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Interviews
研究概览
简要总结
PRINT is a prospective mixed methods study exploring the feasibility and acceptability of providing 3-D printed orthotics specifically an ankle foot orthosis (AFO) to children and adolescents with cerebral palsy.
详细描述
Children with cerebral palsy often require orthotics or external braces to help them function and to manage or decrease pain, for example an ankle-foot orthoses (AFO). AFOs are orthotics worn on the foot and ankle to maintain the ankle in an optimal position to treat and manage spastic equinus; the AFO can help the child stand, walk, and interact with their peers. AFOs can also prevent muscles and tendons from further tightening and shortening which can contribute to pain, discomfort, loss of range of motion, and disability.
Current thermoplastic orthotic services are expensive, have long wait times and delays in receiving the orthotic which can impact on the fit of the orthotic. An ill-fitting orthosis can lead to impaired skin integrity, pain, further disability, non-compliance with wearing the orthosis, and potential surgery. To overcome these issues technological advances have led to 3-D printed orthotics.
Advantages of 3-D printed orthotics encompass: 0.5-2mm tolerances compared to 10-20mm tolerances in hand manufacturing, lighter materials which decrease the energy needed for mobility such as walking, scanning technology to develop the AFO provides better accuracy, and faster times from scanning to receiving the orthotic. Additionally 3-D printed orthotics allow for more personalisation, and different contextual AFO designs such as a specific AFO for sport.
PRINT is a mixed methods study exploring the experience of children and adolescents with cerebral palsy of receiving and wearing a 3-D printed AFO. Children and adolescents will be recruited from the Royal London Hospital pediatric department. Participants will receive their standard thermoplastic AFO (if the study coincides with their need for a new AFO) and a 3-D printed AFO. Participants will wear their 3-D printed AFO for the duration of the study.
The study aims to explore the participants and their parents/guardians experience of getting the 3-D printed AFO, wearing the AFO, and any impact on their lifestyle or function. This experience will be explored through semi-structured interviews with the child/adolescent and their parent/guardian. The study is also collecting data regarding: fit, comfort, skin integrity, durability of the AFO material, functional outcome measures, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children/adolescents 3-16 years of age with hemiplegia resulting from cerebral palsy who are categorized as either level 1 or level 2 as per the Gross Motor Function Classification for cerebral palsy assessed through a chart review (Children at this level will be able to participate in and complete a walking test)
- •Children/adolescents with an identified clinical need for an AFO whose ankle can be held in a corrected position with minimal manual support
- •Children/adolescents who are prescribed an AFO for maintenance only assessed through chart review (maintaining joint position)
- •Children/adolescents who have previously been prescribed a standard thermoplastic orthotic assessed through chart review
排除标准
- •Children/adolescents who require significant amount of manual correction to position their foot
- •Children/adolescents with dystonia, spastic diplegia or total body involvement
- •Children/adolescents who require bilateral orthotics
- •Children/adolescents who require corrective therapy such as serial casting to stretch and reposition the foot and ankle
- •Children/adolescents who are participating in another research study that may impact on ankle range of motion or calf muscle length or increase participant burden on parents/participants.
- •Children/adolescents weighing more than 62kg as assessed through a chart review
- •Children/adolescents that have photo-sensitivity (e.g. epilepsy) assessed through chart review
结局指标
主要结局
Interviews
时间窗: Interviews will be conducted at visit 4 (9 weeks).
Semi-structured interviews with participants and their parents/guardians will be completed to explore the experience of being fitted for and receiving a 3-D printed AFO. Interviews will be analyzed using framework analysis, findings will be reported as common themes identified throughout the interviews. Interviews will last approximately 20-30 minutes.
次要结局
- Pediatric Quality of Life Inventory TM: PedsQL(PedsQL assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).)
- Timed Up and Go Test (TUG)(The TUG will be assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).)
- Range of Motion Assessment(ROM assessment will be completed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).)
- Resource use/clinical data: previous ankle foot orthoses(The resource use and clinical data will be assessed at visit 4 (9 weeks).)
- Resource use/clinical data: Gross Motor Function Classification System(The resource use and clinical data will be assessed at visit 4 (9 weeks) and during screening of patients..)
- Resource use/clinical data: number of fitting appointments(The resource use and clinical data will be assessed at visit 4 (9 weeks).)
- Resource use/clinical data: compliance wearing the AFO(The resource use and clinical data will be assessed at visit 4 (9 weeks).)
- Resource use/clinical data: skin integrity(The resource use and clinical data will be assessed at visit 4 (9 weeks).)
- 3-D scanning of the lower limb(Visit 1 (baseline assessment))