Optimized AFO Care For Children With Cerebral Palsy. (OPTI-CARE)
3 de septiembre de 2026 actualizado por: Merel Brehm, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
86
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Dr. Merel-Anne Brehm, PhD
- Número de teléfono: 020 566 9111
- Correo electrónico: m.a.brehm@amsterdamumc.nl
Ubicaciones de estudio
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North Holland
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Amsterdam, North Holland, Países Bajos, 1105 AZ
- Amsterdam UMC, location AMC
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Contacto:
- Dr. Merel-Anne Brehm, PhD
- Número de teléfono: 020 566 3345
- Correo electrónico: m.a.brehm@amsterdamumc.nl
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Usual AFO care
Usual AFO care, is the current AFO care given in the different participating rehabilitation centres according to their own approach.
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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.
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Standardized protocol for decision making in AFO care
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline to 3 months follow-up in attainment of individual treatment goals
Periodo de tiempo: Individual treatment goals will be established at baseline, and at 3 months and 6 months after the AFO has been delivered.
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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.
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Individual treatment goals will be established at baseline, and at 3 months and 6 months after the AFO has been delivered.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline to 3 months follow-up in gait function
Periodo de tiempo: At baseline, and 3 and 6 months after the AFO has been delivered.
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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
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At baseline, and 3 and 6 months after the AFO has been delivered.
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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
Periodo de tiempo: At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.
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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.
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At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.
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Experiences of participants with the provided AFO treatment at 3 months follow-up
Periodo de tiempo: 3 months after the AFO has been delivered.
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Experiences of participants with the AFO treatment will be explored with a semi-structured interview.
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3 months after the AFO has been delivered.
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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
Periodo de tiempo: At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.
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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.
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At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.
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Change from baseline to 3 months follow-up in quality of life on the EuroQol 5-dimension 5-level (EQ-5D-5L)
Periodo de tiempo: At baseline, and 3 and 6 months after the AFO has been delivered.
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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.
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At baseline, and 3 and 6 months after the AFO has been delivered.
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Change from baseline to 3 months follow-up in perceived pain and stability, assessed with a questionnaire
Periodo de tiempo: At baseline, and 3 and 6 months after the AFO has been delivered.
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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'.
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At baseline, and 3 and 6 months after the AFO has been delivered.
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AFO usage at 3 months follow-up, assessed with a questionnaire
Periodo de tiempo: At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.
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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.
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At baseline (only for participants who already wear an AFO), and 3 and 6 months after the AFO has been delivered.
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Adverse events with the AFO
Periodo de tiempo: Up to 6 months follow-up
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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
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Up to 6 months follow-up
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Health care costs and societal costs assessed with a cost-questionnaire
Periodo de tiempo: Directly post-intervention when the AFO is delivered, and 3 and 6 months after the AFO has been delivered.
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The parents and children fill out a cost questionnaire to record health care costs related to AFO care, as well as societal costs.
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Directly post-intervention when the AFO is delivered, and 3 and 6 months after the AFO has been delivered.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Director de estudio: Prof. dr. Annemieke Buizer, MD PhD, Amsterdam UMC, location Vumc, Amsterdam, Noord-Holland 1081 HV
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de noviembre de 2030
Finalización del estudio (Estimado)
1 de septiembre de 2031
Fechas de registro del estudio
Enviado por primera vez
10 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Publicado por primera vez (Actual)
10 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026.0135
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .