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1.  Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial: the IDYS trial 
BMC Pediatrics  2013;13:175.
Dystonic cerebral palsy is primarily caused by damage to the basal ganglia and central cortex. The daily care of these patients can be difficult due to dystonic movements. Intrathecal baclofen treatment is a potential treatment option for dystonia and has become common practice. Despite this widespread adoption, high quality evidence on the effects of intrathecal baclofen treatment on daily activities is lacking and prospective data are needed to judge the usefulness and indications for dystonic cerebral palsy. The primary aim of this study is to provide level one clinical evidence for the effects of intrathecal baclofen treatment on the level of activities and participation in dystonic cerebral palsy patients. Furthermore, we hope to identify clinical characteristics that will predict a beneficial effect of intrathecal baclofen in an individual patient.
A double blind placebo-controlled multi-center randomized clinical trial will be performed in 30 children with dystonic cerebral palsy. Patients aged between 4 and 25 years old with a confirmed diagnosis of dystonic cerebral palsy, Gross Motor Functioning Classification System level IV or V, with lesions in the cerebral white matter, basal ganglia or central cortex and who are eligible for intrathecal baclofen treatment will be included. Group A will receive three months of continuous intrathecal baclofen treatment and group B will receive three months of placebo treatment, both via an implanted pump. After this three month period, all patients will receive intrathecal baclofen treatment, with a follow-up after nine months. The primary outcome measurement will be the effect on activities of and participation in daily life measured by Goal Attainment Scaling. Secondary outcome measurements on the level of body functions include dystonia, spasticity, pain, comfort and sleep-related breathing disorders. Side effects will be monitored and we will study whether patient characteristics influence outcome.
The results of this study will provide data for evidence-based use of intrathecal baclofen in dystonic cerebral palsy.
Trial registration
Nederlands Trial Register, NTR3642
PMCID: PMC3840690  PMID: 24165282
Cerebral palsy; Dystonia; Dyskinesia; Goal attainment scaling; Intrathecal baclofen; Randomized controlled trial
2.  Optimising Ankle Foot Orthoses for children with Cerebral Palsy walking with excessive knee flexion to improve their mobility and participation; protocol of the AFO-CP study 
BMC Pediatrics  2013;13:17.
Ankle-Foot-Orthoses with a ventral shell, also known as Floor Reaction Orthoses (FROs), are often used to reduce gait-related problems in children with spastic cerebral palsy (SCP), walking with excessive knee flexion. However, current evidence for the effectiveness (e.g. in terms of walking energy cost) of FROs is both limited and inconclusive. Much of this ambiguity may be due to a mismatch between the FRO ankle stiffness and the patient’s gait deviations.
The primary aim of this study is to evaluate the effect of FROs optimised for ankle stiffness on the walking energy cost in children with SCP, compared to walking with shoes alone. In addition, effects on various secondary outcome measures will be evaluated in order to identify possible working mechanisms and potential predictors of FRO treatment success.
A pre-post experimental study design will include 32 children with SCP, walking with excessive knee flexion in midstance, recruited from our university hospital and affiliated rehabilitation centres. All participants will receive a newly designed FRO, allowing ankle stiffness to be varied into three configurations by means of a hinge. Gait biomechanics will be assessed for each FRO configuration. The FRO that results in the greatest reduction in knee flexion during the single stance phase will be selected as the subject’s optimal FRO. Subsequently, the effects of wearing this optimal FRO will be evaluated after 12–20 weeks. The primary study parameter will be walking energy cost, with the most important secondary outcomes being intensity of participation, daily activity, walking speed and gait biomechanics.
The AFO-CP trial will be the first experimental study to evaluate the effect of individually optimised FROs on mobility and participation. The evaluation will include outcome measures at all levels of the International Classification of Functioning, Disability and Health, providing a unique set of data with which to assess relationships between outcome measures. This will give insights into working mechanisms of FROs and will help to identify predictors of treatment success, both of which will contribute to improving FRO treatment in SCP in term.
Trial registration
This study is registered in the Dutch Trial Register as NTR3418.
PMCID: PMC3568048  PMID: 23374998
Cerebral Palsy; Pediatrics; Orthotic devices; Ankle foot orthoses; Intervention studies; Treatment effectiveness; Mobility; Participation; Gait
3.  Splint: the efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial 
BMC Pediatrics  2012;12:38.
Range of motion deficits of the lower extremity occur in about the half of the children with spastic cerebral palsy (CP). Over time, these impairments can cause joint deformities and deviations in the children's gait pattern, leading to limitations in moblity. Preventing a loss of range of motion is important in order to reduce secondary activity limitations and joint deformities. Sustained muscle stretch, imposed by orthotic management in rest, might be an effective method of preventing a decrease in range of motion. However, no controlled study has been performed.
A single blind randomised controlled trial will be performed in 66 children with spastic CP, divided over three groups with each 22 participants. Two groups will be treated for 1 year with orthoses to prevent a decrease in range of motion in the ankle (either with static or dynamic knee-ankle-foot-orthoses) and a third group will be included as a control group and will receive usual care (physical therapy, manual stretching). Measurements will be performed at baseline and at 3, 6, 9 and 12 months after treatment allocation. The primary outcome measure will be ankle dorsiflexion at full knee extension, measured with a custom designed hand held dynamometer. Secondary outcome measures will be i) ankle and knee flexion during gait and ii) gross motor function. Furthermore, to gain more insight in the working mechanism of the orthotic management in rest, morphological parameters like achilles tendon length, muscle belly length, muscle fascicle length, muscle physiological cross sectional area length and fascicle pennation angle will be measured in a subgroup of 18 participants using a 3D imaging technique.
This randomised controlled trial will provide more insight into the efficacy of orthotic management in rest and the working mechanisms behind this treatment. The results of this study could lead to improved treatments.
Trial Registration Number
Nederlands Trial Register NTR2091
PMCID: PMC3328267  PMID: 22448907
Cerebral Palsy; Orthotic management in rest; Knee-ankle-foot orthoses; Ankle dorsiflexion range of motion; Prevention; Gastrocnemius muscle; Muscle morphology; Growth
4.  LEARN 2 MOVE 7-12 years: a randomized controlled trial on the effects of a physical activity stimulation program in children with cerebral palsy 
BMC Pediatrics  2010;10:77.
Regular participation in physical activities is important for all children to stay fit and healthy. Children with cerebral palsy have reduced levels of physical activity, compared to typically developing children. The aim of the LEARN 2 MOVE 7-12 study is to improve physical activity by means of a physical activity stimulation program, consisting of a lifestyle intervention and a fitness training program.
This study will be a 6-month single-blinded randomized controlled trial with a 6-month follow up. Fifty children with spastic cerebral palsy, aged 7 to 12 years, with Gross Motor Function Classification System levels I-III, will be recruited in pediatric physiotherapy practices and special schools for children with disabilities. The children will be randomly assigned to either the intervention group or control group. The children in the control group will continue with their regular pediatric physiotherapy, and the children in the intervention group will participate in a 6-month physical activity stimulation program. The physical activity stimulation program consists of a 6-month lifestyle intervention, in combination with a 4-month fitness training program. The lifestyle intervention includes counseling the child and the parents to adopt an active lifestyle through Motivational Interviewing, and home-based physiotherapy to practise mobility-related activities in the daily situation. Data will be collected just before the start of the intervention (T0), after the 4-month fitness training program (T4), after the 6-month lifestyle intervention (T6), and after six months of follow-up (T12). Primary outcomes are physical activity, measured with the StepWatch Activity Monitor and with self-reports. Secondary outcomes are fitness, capacity of mobility, social participation and health-related quality of life. A random coefficient analysis will be performed to determine differences in treatment effect between the control group and the intervention group, with primary outcomes and secondary outcomes as the dependent variables.
This is the first study that investigates the effect of a combined lifestyle intervention and fitness training on physical activity. Temporary effects of the fitness training are expected to be maintained by changes to an active lifestyle in daily life and in the home situation.
Trial registration
This study is registered in the Dutch Trial Register as NTR2099.
PMCID: PMC2989952  PMID: 21044314
5.  Lower limb strength training in children with cerebral palsy – a randomized controlled trial protocol for functional strength training based on progressive resistance exercise principles 
BMC Pediatrics  2008;8:41.
Until recently, strength training in children with cerebral palsy (CP) was considered to be inappropriate, because it could lead to increased spasticity or abnormal movement patterns. However, the results of recent studies suggest that progressive strength training can lead to increased strength and improved function, but low methodological quality and incomplete reporting on the training protocols hampers adequate interpretation of the results. This paper describes the design and training protocol of a randomized controlled trial to assess the effects of a school-based progressive functional strength training program for children with CP.
Fifty-one children with Gross Motor Function Classification Systems levels I to III, aged of 6 to 13 years, were recruited. Using stratified randomization, each child was assigned to an intervention group (strength training) or a control group (usual care). The strength training was given in groups of 4–5 children, 3 times a week, for a period of 12 weeks. Each training session focussed on four exercises out of a 5-exercise circuit. The training load was gradually increased based on the child's maximum level of strength, as determined by the 8 Repetition Maximum (8 RM). To evaluate the effectiveness of the training, all children were evaluated before, during, directly after, and 6 weeks after the intervention period. Primary outcomes in this study were gross motor function (measured with the Gross Motor Function Measure and functional muscle strength tests) and walking ability (measured with the 10-meter, the 1-minute and the timed stair test). Secondary outcomes were lower limb muscle strength (measured with a 6 RM test, isometric strength tests, and a sprint capacity test), mobility (measured with a mobility questionnaire), and sport activities (measured with the Children's Assessment of Participation and Enjoyment). Spasticity and range of motion were assessed to evaluate any adverse events.
Randomized clinical trials are considered to present the highest level of evidence. Nevertheless, it is of utmost importance to report on the design, the applied evaluation methods, and all elements of the intervention, to ensure adequate interpretation of the results and to facilitate implementation of the intervention in clinical practice if the results are positive.
Trial Registration
Trial Register NTR1403
PMCID: PMC2579291  PMID: 18842125

Results 1-5 (5)