Optimized AFO Care For Children With Cerebral Palsy. (OPTI-CARE)
2026년 9월 3일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
86
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Dr. Merel-Anne Brehm, PhD
- 전화번호: 020 566 9111
- 이메일: m.a.brehm@amsterdamumc.nl
연구 장소
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North Holland
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Amsterdam, North Holland, 네덜란드, 1105 AZ
- Amsterdam UMC, location AMC
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연락하다:
- Dr. Merel-Anne Brehm, PhD
- 전화번호: 020 566 3345
- 이메일: m.a.brehm@amsterdamumc.nl
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline to 3 months follow-up in attainment of individual treatment goals
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline to 3 months follow-up in gait function
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Prof. dr. Annemieke Buizer, MD PhD, Amsterdam UMC, location Vumc, Amsterdam, Noord-Holland 1081 HV
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2030년 11월 1일
연구 완료 (추정된)
2031년 9월 1일
연구 등록 날짜
최초 제출
2026년 8월 10일
QC 기준을 충족하는 최초 제출
2026년 9월 3일
처음 게시됨 (실제)
2026년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 3일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026.0135
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