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Abstract Background 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. Method/Design 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. Discussion 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.

Abstract Background 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. Methods 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. Discussion 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

Abstract Background 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. Methods/Design 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. Discussion 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.

Abstract Background 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. Methods/Results 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. Conclusion 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

Aim: To assess ambulatory activity of children with cerebral palsy (CP), aged 7 to 13 years, and identify associated characteristics. Method: Sixty-two children with spastic CP (39 males, 23 females; mean age 10y 1mo, SD 1y 8mo; age range 7-13y), classified as Gross Motor Function Classification System (GMFCS) levels I to III, participated. Ambulatory activity was measured during 1 week with a StepWatch activity monitor as steps per day, and time spent at medium and high step rates. Multiple linear regression analyses were performed following a backward selection procedure until only independent variables with p less than 0.05 remained in the model. Ambulatory activity outcome parameters served as dependent variables, and disease, personal, and environmental characteristics as independent variables. Ambulatory activity was corrected for body height. Results: Children took more steps during school days (5169 steps, SD 1641) than during weekend days (4158 steps, SD 2048; p less than 0.001). Higher GMFCS level, bilateral CP, and higher age were associated with lower ambulatory activity on school days (R[superscript 2] ranged from 43-53%), whereas bilateral CP, higher age, and no sport club participation were associated with lower ambulatory activity in the weekend (R[superscript 2] ranged from 21-42%). Correcting for body height decreased the association with age. Interpretation: Interventions should focus at increasing physical activity at the weekend for children with bilateral spastic CP.

The objective of the study was to evaluate the effectiveness of functional progressive resistance exercise (PRE) training on walking ability in children with cerebral palsy (CP). Fifty-one ambulant children with spastic CP (mean age 10 years 5 months, 29 boys) were randomized to an intervention (n=26) or control group (n=25, receiving usual care). The intervention consisted of 12 weeks functional PRE circuit training, for 3 times a week. Main outcome measures were walking ability and participation. Secondary outcomes were muscle strength and anaerobic muscle power. Possible adverse outcomes were spasticity and passive range of motion (ROM). Muscle strength increased significantly in the training group compared to the control group, but walking ability, participation and anaerobic muscle power did not change. Spasticity and ROM remained unchanged, except for a significant decrease in rectus femoris length in the intervention group. It is concluded that twelve weeks of functional PRE-training does not improve walking ability, despite improved muscle strength. (Contains 1 figure and 2 tables.)

Aim: The objective of this study was to assess the validity of a mobility questionnaire (MobQues) that was developed to measure parent-reported mobility limitations in children with cerebral palsy (CP). Method: The parents of 439 children with CP (256 males and 183 females; age range 2-18y; Gross Motor Function Classification System [GMFCS] levels I-IV) completed the mobility questionnaire (MobQues). To assess content validity, we linked all meaningful concepts of the MobQues items to the International Classification of Functioning, Disability and Health (ICF). To assess construct validity, we compared the total scores of the two versions of the MobQues (MobQues47 and MobQues28) according to GMFCS level, and determined Pearson's correlation coefficient ("r") with the Gross Motor Function Measure-66 (GMFM-66). Results: Content validity was demonstrated by the fact that 46 of the 47 MobQues items were linked to categories in the "Mobility" chapter of the ICF. Construct validity was demonstrated by the finding that MobQues scores decreased with increasing GMFCS levels (p less than 0.001). In a subgroup of 162 children, positive correlations were found between total scores and the GMFM-66 (MobQues47, r=0.75; MobQues28, r=0.67, p less than 0.001). Interpretation: The results of this study provide evidence supporting the content and construct validity of the MobQues as a measure of mobility limitation in children with CP.

Aim: The objective of this longitudinal study was to describe the course of social functioning and communication in children with cerebral palsy (CP) over a 3-year period, its difference with the normative course, and its relationship with disease characteristics and personal and environmental factors. Method: Participants in this study were 110 children with CP (70 males, 40 females) with a mean age of 11 years and 3 months (SD 1y 8mo). Social functioning and communication were measured with the Vineland Adaptive Behavior Scales. Comparisons were made with normative data; data were analysed with generalized estimating equations. According to the Gross Motor Function Classification System (GMFCS), 50 of the 110 children were categorized as GMFCS level I, 16 as level II, 13 as level III, 13 as level IV, and 18 as level V. Results: The course of social functioning over a 3-year period showed an increase in restrictions in children with CP (p less than 0.001). Restrictions in communication increased more in children with the most severe forms of CP (p less than 0.001). In addition to disease characteristics (GMFCS category, presence of epilepsy, and speech problems), personal factors (externalizing behaviour problems) and environmental factors (having no siblings, low parental level of education, and parental stress) were associated with greater restrictions in social functioning and communication. Interpretation: The results indicate that it is important to focus not only on the medical treatment of children with CP, but also on their behavioural problems and social circumstances, and to support the parents so that social functioning and communication in these children may be improved.

Aim: The objective of this study was to assess the reliability of a mobility questionnaire (MobQues) that was developed to measure the mobility limitations of children with cerebral palsy (CP) as rated by their parents. A clinical version of the questionnaire, consisting of 47 items (MobQues47), is available, as well as a research version with 28 items for a specific population (MobQues28). Total scores are expressed on a scale of 0 to 100. Method: We assessed the interrater reliability between both parents of 289 children with CP (168 males, 121 females, age range 2-13y, Gross Motor Function Classification System levels I-IV) and the intrarater reliability within a subgroup of 38 parents (of 23 children) who completed the MobQues twice. Results: For the interrater reliability, high intraclass correlation coefficients (ICCs) were found for the MobQues47 (ICC 0.92) and MobQues28 (ICC 0.87). The standard error of measurement (SEM) was 7.8 and 8.9 respectively. As expected, the intrarater reliability was higher, as represented by higher ICCs (0.96-0.99) and lower SEMs (3.5-4.9) for both MobQues versions. Interpretation: The results of this study indicate that the MobQues is a reliable instrument to measure the mobility limitations of children with CP.

Aim: To investigate the predictive value of motor testing at 1 year for motor and mental outcome at 2 years after perinatal hypoxic-ischaemic encephalopathy (HIE) in term neonates. Method: Motor and mental outcome at 2 years was assessed with the Bayley Scales of Infant Development, 2nd edition (BSID-II) in 32 surviving children (20 males, 12 females; mean gestational age 40.2 wk, SD 1.4; mean birthweight 3217g, SD 435) participating in a prospective cohort study of HIE. The predictive value of three motor tests (Alberta Infant Motor Scale [AIMS], BSID-II, and the Neurological Optimality Score [NOS]) at 1 year was analysed, in addition to predictions based on neonatal Sarnat staging and magnetic resonance imaging (MRI). Poor motor test results were defined as an AIMS z-score of less than -2, a psychomotor developmental index of the BSID-II of less than 70, or a NOS of less than 26. Poor motor and poor mental outcome at 2 years was defined as a psychomotor developmental index or mental developmental index of the BSID-II of less than 70. Results: Twelve children, all with Sarnat grade II, had a poor motor outcome and 12 children, of whom one had Sarnat grade I, had a poor mental outcome at 2 years. Nine children had cerebral palsy, of whom five had quadriplegia, three had dyskinesia, and one had hemiplegia. Poor motor tests at 1 year increased the probability of a poor motor outcome from 71% (range 92 to 100%), and a poor mental outcome from 59% (range 77 to 100%) in children with Sarnat grade II and abnormal MRI, assessed with the AIMS and BSID-II or NOS respectively. Interpretation: Additional motor testing at 1 year improves the prediction of motor and mental outcome at 2 years in children with Sarnat grade II and abnormal MRI. (Contains 5 tables.)

Aim: The aim of this study was to describe the course of motor performance and analyse its relationship with motor capacity over a period of 3 years in 104 children (66 males, 38 females; 43% of those initially invited) with cerebral palsy (CP) aged 9, 11, and 13 years at the start of the study. Forty-one had hemiplegia, 42 diplegia, 21 tetraplegia; 83 spastic CP, 17 dyskinetic/mixed, and four ataxic CP. Gross Motor Function Classification System (GMFCS) levels were I, n=49; II, n=15; III, n=10; IV, n=12; and V, n=18. Method: Motor performance (what a child does do) was determined using the gross motor skills subscale of the Vineland Adaptive Behavior Scales and motor capacity [what a child can do] was determined using the Gross Motor Function Measure-66 (GMFM-66). The measurements were performed annually over a period of 3 years. Results: The course of motor performance in mildly affected children (GMFCS level I) was more favorable than in more severely affected children. An increase in motor capacity was significantly related to an improvement in motor performance over the 3 years. Interpretation: Training motor capacity in children with CP seems to be important for improving motor performance. Interventions should also focus on environmental adaptations and improving mobility equipment. A limitation of this study was that the instruments used did not contain the same items on capacity and performance level.

To assess attainment of individual treatment goals one year after intrathecal baclofen (ITB) pump implantation in individuals with dyskinetic cerebral palsy (CP). A multi-center prospective cohort study was conducted including 34 non-walking individuals with severe dyskinetic CP, classified as Gross Motor Function Classification System (GMFCS) IV/V, aged 4–24 years, 12 months after pump implantation. The main outcome measure was Goal Attainment Scaling (GAS). Predictors of GAS results were analyzed. Complications were registered systematically. Seventy-one percent of individuals with dyskinetic CP fully achieved one or more treatment goals. One or more treatment goals were partially achieved in 97% of individuals. Two factors were found to be associated with attainment of goals: Dyskinesia Impairment Scale (DIS) score at baseline and the difference in pain score between baseline and follow-up. These two variables explain 30% of the variance in the outcome. Intrathecal baclofen is effective in achieving individual treatment goals in children and young adults with dyskinetic CP after nine to 12 months of ITB treatment. A positive outcome on treatment goals is, for a small part, associated with higher severity of dystonia at baseline and with improvement of pain during treatment. Dutch Trial Register, number NTR3642. Intrathecal baclofen treatment is effective in attainment of personal treatment goals, one year after pump implantation in patients with dyskinetic cerebral palsy. A positive outcome on treatment goals is, for a small part, related to higher severity of dystonia at the start and on improvement of pain during treatment. [ABSTRACT FROM AUTHOR]