Effectiveness And Costeffectiveness Of Optimized Ankle Foot Orthosis Care For Children With Cerebral Palsy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change from baseline to 3 months follow-up in attainment of individual treatment goals
研究概览
简要总结
Ankle-foot orthoses (AFOs) are widely prescribed in children with cerebral palsy (CP) to improve their gait, enhance mobility and prevent secondary complications during growth. However, in the Netherlands there is considerable variation in how AFO treatment is provided, and AFOs are not always optimally effective.
In adults with neuromuscular disorders, it has been proven that optimized orthotic care delivered according to a standardized protocol reduces practice variation and is more effective in achieving individual treatment goals and improving patient satisfaction than usual orthotic care. For children with CP, it is expected that orthotic care based on a similarly standardized and optimized approach, will support better decision-making regarding the most appropriate orthosis and improve the overall AFO care process. In addition, such an approach may reduce healthcare costs compared to current AFO care, for example by reducing the need for consultations with other healthcare professionals.
The aim of this study is to develop a new approach to AFO treatment in children with CP. This will be done by developing a standardized protocol that provides guidelines and instructions for healthcare professionals on key aspects of AFO selection, user training and evaluation. First, the effects of current AFO care will be evaluated in a group of 43 children with CP. After development of the new optimized protocol, the effects of optimized AFO care will be evaluated in a second group of 43 children with CP. The investigators will compare the attaining of personal treatment goals at 3 months follow-up between optimized AFO care and usal AFO care, and assess the cost-effectiveness of both interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy
- •Age range from independent walking onset up to 18 years
- •Ability to walk independently with or without a walking aid (e.g., a walker)
- •Indication for a first or repeated prescription of AFO for daytime use to improve gait function
排除标准
- •Orthopaedic or neurosurgical surgery within the past 6 months (e.g., SDR)
- •Child and parent do not speak Dutch
研究组 & 干预措施
Usual AFO care
Usual AFO care, is the current AFO care given in the different participating rehabilitation centres according to their own approach.
Optimized AFO care
Optimized AFO care, this group receives optimized AFO care following the new standardized protocol that will be developed during this study.
干预措施: Optimized AFO care (Procedure)
结局指标
主要结局
Change from baseline to 3 months follow-up in attainment of individual treatment goals
时间窗: Individual treatment goals will be established at baseline, and at 3 months and 6 months after the AFO has been delivered.
The individual treatment goals will be set and evaluated using goal attainment scaling (GAS). Goals will be defined at the activity and/or participation level and are rated on a scale ranging from -3 to +2. (where the current situation is defined as -2 and the desired attainment goal as 0). Attainment of the goals at 3 and 6 months follow-up will be scored as -3 for worsened, -2 for unchanged, -1 for somewhat less than expected, 0 for expected outcome, +1 for somewhat more than expected, and +2 for much more than expected.
次要结局
- Adverse events with the AFO(Up to 6 months follow-up)
- Change from baseline to 3 months follow-up in gait function(At baseline, and 3 and 6 months after the AFO has been delivered.)
- Orthosis satisfaction at 3 months follow-up, assessed with the Dutch version of the client satisfaction with device (D-CSD) module of the OPUS questionnaire(At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.)
- Experiences of participants with the provided AFO treatment at 3 months follow-up(3 months after the AFO has been delivered.)
- Orthosis satisfaction at 3 months follow-up, assessed with the Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-Quest) questionnaire(At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.)
- Change from baseline to 3 months follow-up in quality of life on the EuroQol 5-dimension 5-level (EQ-5D-5L)(At baseline, and 3 and 6 months after the AFO has been delivered.)
- Change from baseline to 3 months follow-up in perceived pain and stability, assessed with a questionnaire(At baseline, and 3 and 6 months after the AFO has been delivered.)
- AFO usage at 3 months follow-up, assessed with a questionnaire(At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.)
- Health care costs and societal costs assessed with a cost-questionnaire(Directly post-intervention when the AFO is delivered, and 3 and 6 months after the AFO has been delivered.)
研究者
Merel Brehm
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)