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

3. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

86

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Niederlande
    • North Holland
      • Amsterdam, North Holland, Niederlande, 1105 AZ
        • Amsterdam UMC, location AMC
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Verfahren: Optimized AFO care
Standardized protocol for decision making in AFO care

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline to 3 months follow-up in attainment of individual treatment goals
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline to 3 months follow-up in gait function
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Mitarbeiter

ZonMw: The Netherlands Organisation for Health Research and Development

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. November 2030

Studienabschluss (Geschätzt)

1. September 2031

Studienanmeldedaten

Zuerst eingereicht

10. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. September 2026

Zuerst gepostet (Tatsächlich)

10. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026.0135

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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