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NCT Number: NCT07811336

Optimized AFO 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.

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Key information

Conditions

Cerebral Palsy (CP) Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Personal Satisfaction

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location contact

Dr. Merel-Anne Brehm, PhD

CONTACT

[email protected]

020 566 3345

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optimized AFO care

Procedure

Standardized protocol for decision making in AFO care

Primary outcomes

  1. Change from baseline to 3 months follow-up in attainment of individual treatment goals

    Time frame: Individual treatment goals will be established at baseline, and at 3 months and 6 months after the AFO has been delivered.

    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.

Secondary outcomes

  1. Change from baseline to 3 months follow-up in gait function

    Time frame: At baseline, and 3 and 6 months after the AFO has been delivered.

    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

  2. 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

    Time frame: At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.

    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.

  3. Experiences of participants with the provided AFO treatment at 3 months follow-up

    Time frame: 3 months after the AFO has been delivered.

    Experiences of participants with the AFO treatment will be explored with a semi-structured interview.

  4. 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

    Time frame: At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.

    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.

  5. Change from baseline to 3 months follow-up in quality of life on the EuroQol 5-dimension 5-level (EQ-5D-5L)

    Time frame: At baseline, and 3 and 6 months after the AFO has been delivered.

    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.

  6. Change from baseline to 3 months follow-up in perceived pain and stability, assessed with a questionnaire

    Time frame: At baseline, and 3 and 6 months after the AFO has been delivered.

    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'.

  7. AFO usage at 3 months follow-up, assessed with a questionnaire

    Time frame: At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.

    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.

  8. Adverse events with the AFO

    Time frame: Up to 6 months follow-up

    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

  9. Health care costs and societal costs assessed with a cost-questionnaire

    Time frame: Directly post-intervention when the AFO is delivered, and 3 and 6 months after the AFO has been delivered.

    The parents and children fill out a cost questionnaire to record health care costs related to AFO care, as well as societal costs.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Merel-Anne Brehm, PhD

CONTACT

[email protected]

020 566 9111

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: OPTI-CARE

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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