Optimized AFO Care For Children With Cerebral Palsy.

NCT07811336 | Not Yet Recruiting

• 1 other identifier: 2026.0135
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy (CP)

Keywords

Cerebral Palsy (CP); Children; Ankle foot orthosis; Optimization protocol; Cost-effectiveness; Goal Attainment Scale; Quality of life; Satisfaction; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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.

Study Arms (2)

Usual AFO care

NO INTERVENTION

Usual AFO care, is the current AFO care given in the different participating rehabilitation centres according to their own approach.

Optimized AFO care

EXPERIMENTAL

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

Interventions

Optimized AFO care PROCEDURE

Standardized protocol for decision making in AFO care

Optimized AFO care

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 40856378 BACKGROUND

• 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.

  PMID: 18758669 BACKGROUND

• 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.

  PMID: 25274143 BACKGROUND

• 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.

  PMID: 11952649 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Cerebral Palsy; Personal Satisfaction

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Prof. dr. Annemieke Buizer, MD PhD

  Amsterdam UMC, location Vumc, Amsterdam, Noord-Holland 1081 HV

  STUDY DIRECTOR

Central Study Contacts

Dr. Merel-Anne Brehm, PhD

CONTACT

020 566 9111; m.a.brehm@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)