Optimized AFO Care For Children With Cerebral Palsy. (OPTI-CARE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy (CP)
• Intervention / Treatment: Procedure: Optimized AFO care

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Merel-Anne Brehm, PhD; Phone Number: 020 566 9111; Email: m.a.brehm@amsterdamumc.nl

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, location AMC
      • Contact: Dr. Merel-Anne Brehm, PhD; Phone Number: 020 566 3345; Email: m.a.brehm@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Orthopaedic or neurosurgical surgery within the past 6 months (e.g., SDR)
• Child and parent do not speak Dutch

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual AFO care; Usual AFO care, is the current AFO care given in the different participating rehabilitation centres according to their own approach.
Experimental: Optimized AFO care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Individual treatment goals will be established at baseline, and at 3 months and 6 months after the AFO has been delivered.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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'.	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.	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	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.	Directly post-intervention when the AFO is delivered, and 3 and 6 months after the AFO has been delivered.

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Study Director: Prof. dr. Annemieke Buizer, MD PhD, Amsterdam UMC, location Vumc, Amsterdam, Noord-Holland 1081 HV

Publications and helpful links

General Publications

• Wingstrand M, Hagglund G, Rodby-Bousquet E. Ankle-foot orthoses in children with cerebral palsy: a cross sectional population based study of 2200 children. BMC Musculoskelet Disord. 2014 Oct 2;15:327. doi: 10.1186/1471-2474-15-327.
• VAN Duijnhoven E, Koopman FS, Tuijtelaars J, Altmann V, VAN Dongen JM, Janse M, Nollet F, Brehm MA. Specialized orthotic care to improve functioning in adults with neuromuscular disorders: results of an open-label blinded end-point randomized controlled trial. Eur J Phys Rehabil Med. 2025 Jun;61(3):496-508. doi: 10.23736/S1973-9087.25.08770-2.
• Brehm MA, Harlaar J, Schwartz M. Effect of ankle-foot orthoses on walking efficiency and gait in children with cerebral palsy. J Rehabil Med. 2008 Jul;40(7):529-34. doi: 10.2340/16501977-0209.
• Morris C, Newdick H, Johnson A. Variations in the orthotic management of cerebral palsy. Child Care Health Dev. 2002 Mar;28(2):139-47. doi: 10.1046/j.1365-2214.2002.00259.x.

Helpful Links

• Richtlijn 'Cerebrale Parese bij kinderen'. Vereniging voor revalidatieartsen, 2024.
• Richtlijn Beenorthesen naar maat bij neuromusculaire aandoeningen. Vereniging voor revalidatieartsen, 2012.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: August 10, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Quality of life; Children; Satisfaction; Cost-effectiveness; Cerebral Palsy (CP); Ankle foot orthosis; Optimization protocol; Goal Attainment Scale
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Behavior; Cerebral Palsy; Personal Satisfaction
• Other Study ID Numbers: 2026.0135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No