Understanding the Factors Affecting Compliance in Children With Cerebral Palsy Supplied With Ankle Foot Orthoses (AFOs) Using Quantitative Measurement of Function and Qualitative Evaluation of Experience and Wellbeing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Gait Profile Score (GPS) in degrees
研究概览
简要总结
Children with cerebral palsy are frequently supplied with Ankle Foot Orthoses (AFOs) to aid their walking. There are huge benefits to patients in staying physically active into adulthood but this becomes more challenging as children progress through adolescence. It is possible to measure the functional benefits of AFO use, however the investigators suspect the correlation with patient compliance is poor. By combining quantitative analysis using 3D gait analysis with qualitative exploration of children's experience the investigators hope to gain a better understanding of the factors influencing children's compliance. This compliance will be measured using sensors mounted in the AFOs, over a 3 month period. The investigators hope this research will help clinicians manage patients better and also inform changes in splint design.
详细描述
Background
About 1 in 400 children born in the UK has cerebral palsy (CP). CP is caused by injury to the foetal or infant brain, and results in problems with walking, balance and coordination. One of the most common strategies for treating walking limitations in children with CP is the use of Ankle Foot Orthoses (AFOs), which aim to correct deformity and improve walking efficiency.
Keeping children with CP mobile is important, not only because physical fitness contributes to quality of life, but also because lack of physical activity can result in a downwards spiral: low physical fitness can make activities of daily living more difficult, leading to further reduction in activity and fitness. One study showed that children with CP at age 10 who walked and did not use a wheelchair had only a small chance (11%) of becoming non-ambulatory, vs. 34% of children using a wheelchair.
AFOs can play an important part in keeping children with CP mobile, and reducing the need for a wheelchair. However, there is evidence that when they reach adolescence, some children are reluctant to wear their AFOs. One of the parents participating in a previous study said "... now we have a 13-year-old who just wants to be like other 13- year-old girls, and she doesn't want to wear AFOs ...". Studies show that children with CP often lose functional ability through adolescence and early adulthood, but it is not clear how that relates to their use or non-use of prescribed AFOs. There are also many factors which contribute to compliance with clinical recommendation and a scarcity of research into the psychological elements which can impact on this, though research indicates that perception and empowerment can increase the likelihood of a successful intervention application and compliance rates.
In this application the investigators seek to explore both the objective, functional benefits of using AFOs and the subjective experience of children and their families. A combination of quantitative and qualitative approaches will be used to understand the factors affecting children's compliance.
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
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spastic diplegia or hemiplegia GMFCS level 1 or 2 (ie independently mobile) Gait pattern compatible with achieving clean foot strikes on the force platforms in the gait laboratory.
- •Able to understand sufficiently to co-operate happily with the gait analysis process and participate in the interviews.
- •In main stream education
排除标准
- •Any behavioural or communication problems which would make them unable to comply with the protocol.
- •Any invasive procedures (eg surgery, Botulinum toxin injections) in the previous 6 months.
- •Any invasive procedures (eg surgery, Botulinum toxin injections) planned in the next 6 months.
结局指标
主要结局
Gait Profile Score (GPS) in degrees
时间窗: At baseline
A 3D movement analysis system will be used to record the full kinematics and kinetics of the child's gait with and without AFOs. The outcome measure extracted will be the GPS, which documents the average deviation in joint angles (in degrees) across multiple joints compared with an unimpaired control cohort. Unimpaired data are already available in the host unit.
Walking speed (m/s)
时间窗: At baseline
This will be measured in a clinical movement analysis laboratory using timing gates at either end of the walkway.
Compliance (minutes per day)
时间窗: At end of 3 months of use
The compliance will be recorded using Orthotimer sensors embedded in the body of the AFO. The sensors record usage throughout the day in 15min intervals.
Patient Experience
时间窗: At end of 3 months of use
Qualitative interviews - an entirely qualitative approach will be used to draw out narrative themes. No scoring scale is used.
次要结局
未报告次要终点