Cerebral Palsy (CP)
Conditions
Keywords
Cerebral Palsy (CP), Children, Ankle foot orthosis, Optimization protocol, Cost-effectiveness, Goal Attainment Scale, Quality of life, Satisfaction, Rehabilitation
Brief 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. 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.
Interventions
PROCEDUREOptimized AFO care
Standardized protocol for decision making in AFO care
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 3 months follow-up in attainment of individual treatment goals | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 3 months follow-up in gait function | 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 |
| 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 | 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. |
| Experiences of participants with the provided AFO treatment at 3 months follow-up | 3 months after the AFO has been delivered. | Experiences of participants with the AFO treatment will be explored with a semi-structured interview. |
| 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 | 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. |
| Change from baseline to 3 months follow-up in quality of life on the EuroQol 5-dimension 5-level (EQ-5D-5L) | 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. |
| Change from baseline to 3 months follow-up in perceived pain and stability, assessed with a questionnaire | 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'. |
| AFO usage at 3 months follow-up, assessed with a questionnaire | 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. |
| Adverse events with the AFO | 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 |
| Health care costs and societal costs assessed with a cost-questionnaire | 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. |
Countries
Netherlands
Contacts
CONTACTDr. Merel-Anne Brehm, PhD
STUDY_DIRECTORProf. dr. Annemieke Buizer, MD PhD
Amsterdam UMC, location Vumc, Amsterdam, Noord-Holland 1081 HV
Outcome results
None listed