Cerebral Palsy (CP)OPTI-CARENCT07811336
Optimized AFO Care For Children With Cerebral Palsy.
A study testing Optimized AFO care in people with Cerebral Palsy (CP), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Optimized AFO care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2026to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Orthopaedic or neurosurgical surgery within the past 6 months (e.g., SDR)
- Child and parent do not speak Dutch
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
Dr. Merel-Anne Brehm, PhD, 020 566 3345, m.a.brehm@amsterdamumc.nl
About this study
Official title: 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Optimized AFO care
- Keywords
- Cerebral Palsy (CP), Children, Ankle foot orthosis, Optimization protocol, Cost-effectiveness, Goal Attainment Scale, Quality of life, Satisfaction, Rehabilitation
- Medical subject headings
- Cerebral Palsy, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized AFO careProcedure or surgery
Standardized protocol for decision making in AFO care
| Study group | Role | What they receive |
|---|---|---|
| Usual AFO care | No intervention | Usual AFO care, is the current AFO care given in the different participating rehabilitation centres according to their own approach. |
| Optimized AFO care | Experimental | Optimized AFO care, this group receives optimized AFO care following the new standardized protocol that will be developed during this study. Receives: Procedure: Optimized AFO care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 3 months follow-up in attainment of individual treatment goals
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.
Measured: Individual treatment goals will be established at baseline, and at 3 months and 6 months after the AFO has been delivered.
Secondary outcomes (9)
Change from baseline to 3 months follow-up in gait function
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
Measured: 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
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.
Measured: 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
Experiences of participants with the AFO treatment will be explored with a semi-structured interview.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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'.
Measured: At baseline, and 3 and 6 months after the AFO has been delivered.
AFO usage at 3 months follow-up, assessed with a questionnaire
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.
Measured: 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
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
Measured: Up to 6 months follow-up
Health care costs and societal costs assessed with a cost-questionnaire
The parents and children fill out a cost questionnaire to record health care costs related to AFO care, as well as societal costs.
Measured: Directly post-intervention when the AFO is delivered, and 3 and 6 months after the AFO has been delivered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Merel Brehm, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Prof. dr. Annemieke Buizer, MD PhD, Study director, Amsterdam UMC, location Vumc, Amsterdam, Noord-Holland 1081 HV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811336
- Sponsor's protocol ID
- 2026.0135
- Acronym
- OPTI-CARE
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40856378Brehm 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.
PubMed 18758669Wingstrand 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.
PubMed 25274143Morris 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.
PubMed 11952649
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness And Costeffectiveness Of Optimized Ankle Foot Orthosis Care For Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT07811336
- Acronym / sponsor ID
- OPTI-CARE / 2026.0135
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral Palsy (CP), Children, Ankle foot orthosis, Optimization protocol, Cost-effectiveness, Goal Attainment Scale, Quality of life, Satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual AFO care | No intervention | –Usual AFO care, is the current AFO care given in the different participating rehabilitation centres according to their own approach. |
| Optimized AFO care | Experimental | Procedure: Optimized AFO careOptimized AFO care, this group receives optimized AFO care following the new standardized protocol that will be developed during this study. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Orthopaedic or neurosurgical surgery within the past 6 months (e.g., SDR)
- Child and parent do not speak Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized AFO careStandardized protocol for decision making in AFO care | Procedure or surgery | Optimized AFO care |
Primary outcome
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.
9 secondary outcomes
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.
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.
Experiences of participants with the provided AFO treatment at 3 months follow-up
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: At baseline, and 3 and 6 months after the AFO has been delivered.
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.
Adverse events with the AFO
Time frame: Up to 6 months follow-up
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 40856378VAN 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.
- Background: PubMed 18758669Brehm 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.
- Background: PubMed 25274143Wingstrand 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.
- Background: PubMed 11952649Morris 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.
- Richtlijn 'Cerebrale Parese bij kinderen'. Vereniging voor revalidatieartsen, 2024.Link provided by the sponsor.
- Richtlijn Beenorthesen naar maat bij neuromusculaire aandoeningen. Vereniging voor revalidatieartsen, 2012.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. dr. Annemieke Buizer, MD PhD study director
Amsterdam UMC, location Vumc, Amsterdam, Noord-Holland 1081 HV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized AFO care in people with Cerebral Palsy (CP), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Merel-Anne Brehm, PhD (020 566 9111, m.a.brehm@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07811336, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.