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NOT YET RECRUITING
NCT07811336
NA

Optimized AFO Care For Children With Cerebral Palsy.

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

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.

Official title: Effectiveness And Costeffectiveness Of Optimized Ankle Foot Orthosis Care For Children With Cerebral Palsy.

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2026-09

Completion Date

2031-09

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

PROCEDURE

Optimized AFO care

Standardized protocol for decision making in AFO care

Locations (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands