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.
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
Orthopaedic or neurosurgical surgery within the past 6 months (e.g., SDR)
Child and parent do not speak Dutch
Sequential
Optimized AFO care
Procedure/SurgeryStandardized protocol for decision making in AFO care
Change from baseline to 3 months follow-up in attainment of individual treatment goals
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.
Change from baseline to 3 months follow-up in gait function
Gait function will be evaluated with a 10-meter walking test and simultaneous video assessment. Besides walking speed, the following outcomes will be assessed: foot contact at initial contact, knee angle during midstance, foot contact during midstance, minimal knee angle during late stance, clearance at early swing, and clearance at late swing
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
The D-CSD contains 10 items rated on a 5-point Likert scale ranging from 0; 'strongly disagree' to 4; 'strongly agree', with a total score ranging from 0-40.
Experiences of participants with the provided AFO treatment at 3 months follow-up
Experiences of participants with the AFO treatment will be explored with a semi-structured interview.
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
The D-Quest assesses the satisfaction with aspects related to the orthotic device and the provided services. The questionnaire consists of 9 questions about characteristics of the orthotic device, all scored on a 5-point scale, ranging from 'not satisfied at all' to 'very satisfied'. Total scores for the device component range from 9 to 45, with higher scores indicating greater satisfaction.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
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