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

3 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

86

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Olanda
    • North Holland
      • Amsterdam, North Holland, Olanda, 1105 AZ
        • Amsterdam UMC, location AMC
        • Contatto:

Criteri di partecipazione

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Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Usual AFO care
Usual AFO care, is the current AFO care given in the different participating rehabilitation centres according to their own approach.
Sperimentale: Optimized AFO care
Optimized AFO care, this group receives optimized AFO care following the new standardized protocol that will be developed during this study.
Procedura: Optimized AFO care
Standardized protocol for decision making in AFO care

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline to 3 months follow-up in attainment of individual treatment goals
Lasso di tempo: 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.
Individual treatment goals will be established at baseline, and at 3 months and 6 months after the AFO has been delivered.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline to 3 months follow-up in gait function
Lasso di tempo: 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
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
Lasso di tempo: 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.
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
Lasso di tempo: 3 months after the AFO has been delivered.
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
Lasso di tempo: 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.
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)
Lasso di tempo: 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.
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
Lasso di tempo: 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'.
At baseline, and 3 and 6 months after the AFO has been delivered.
AFO usage at 3 months follow-up, assessed with a questionnaire
Lasso di tempo: 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.
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
Lasso di tempo: 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
Up to 6 months follow-up
Health care costs and societal costs assessed with a cost-questionnaire
Lasso di tempo: 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.
Directly post-intervention when the AFO is delivered, and 3 and 6 months after the AFO has been delivered.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Collaboratori

ZonMw: The Netherlands Organisation for Health Research and Development

Investigatori

  • Direttore dello studio: Prof. dr. Annemieke Buizer, MD PhD, Amsterdam UMC, location Vumc, Amsterdam, Noord-Holland 1081 HV

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 novembre 2030

Completamento dello studio (Stimato)

1 settembre 2031

Date di iscrizione allo studio

Primo inviato

10 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 settembre 2026

Primo Inserito (Effettivo)

10 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026.0135

Piano per i dati dei singoli partecipanti (IPD)

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SÌ

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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