An interventional study of Optimized AFO care in Cerebral Palsy (CP), sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Not yet recruiting at 1 site in Netherlands. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 86 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Usual AFO care, is the current AFO care given in the different participating rehabilitation centres according to their own approach.
Optimized AFO care, this group receives optimized AFO care following the new standardized protocol that will be developed during this study.
Procedure: Optimized AFO care
Standardized 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.
Time frame: Individual treatment goals will be established at baseline, and at 3 months and 6 months after the AFO has been delivered.
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
Time frame: 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
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.
Time frame: 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
Experiences of participants with the AFO treatment will be explored with a semi-structured interview.
Time frame: 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
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.
Time frame: 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)
The EQ-5D-5L contains five questions about mobility, self-care, usual activities, pain/discomfort and anxiety and depression scored on a 5-point scale indicating the degree of problems with each dimension and one question about experienced health scored on a 0-100 visual analogue scale.
Time frame: 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
A 10-point Numeric Rating Scale (NRS) where for pain 0 is 'no pain at all' and 10 is 'unbearable pain', and for stability 0 is 'not stable at all' and 10 is 'extremely stable'.
Time frame: At baseline, and 3 and 6 months after the AFO has been delivered.
AFO usage at 3 months follow-up, assessed with a questionnaire
A questionnaire containing items about how often the child wears the AFO inside and outside the house and for how many hours per day and how many days per week.
Time frame: At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.
Adverse events with the AFO
The following adverse events reported by the participant or observed by the investigator or orthotist will be recorded; pressure sores, abrasions, pain due to the AFO, and material damage of the AFO
Time frame: Up to 6 months follow-up
Health care costs and societal costs assessed with a cost-questionnaire
The parents and children fill out a cost questionnaire to record health care costs related to AFO care, as well as societal costs.
Time frame: Directly post-intervention when the AFO is delivered, and 3 and 6 months after the AFO has been delivered.
Plan to share: Yes — Anonymized individual participant data (IPD) and meta data will be made available to third parties via DataverseNL Amsterdam UMC. Other anonymized IPD and documents will be made available on request including data analysis codes such as SPSS syntaxes or R scripts.
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