Physical activity stimulation program for children with cerebral palsy did not improve physical activity: a randomised trial

AbstractQuestion: In children with cerebral palsy, does a 6-month physical activity stimulation program improve physical activity, mobility capacity, fitness, fatigue and attitude towards sports more than usual paediatric physiotherapy? Design: Multicentre randomised controlled trial with concealed allocation, blinded assessments and intention-to-treat analysis. Participants: Forty-nine walking children (28 males) aged 7–13 years with spastic cerebral palsy and severity of the disability classified as Gross Motor Function Classification System level I–III. Intervention: The intervention group followed a 6-month physical activity stimulation program involving counselling through motivational interviewing, home-based physiotherapy, and 4 months of fitness training. The control group continued their usual paediatric physiotherapy. Outcome measures: Primary outcomes were walking activity (assessed objectively with an activity monitor) and parent-reported physical activity (Activity Questionnaire for Adults and Adolescents). Secondary outcomes were: mobility capacity, consisting of Gross Motor Function Measure-66 (GMFM-66), walking capacity and functional strength, fitness (aerobic and anaerobic capacity, muscle strength), self-reported fatigue, and attitude towards sport (child and parent). Assessments were performed at baseline, 4 months, 6 months and 12 months. Results: There were no significant intervention effects for physical activity or secondary outcomes at any assessment time. Positive trends were found for parent-reported time at moderate-to-vigorous intensity (between-group change ratio=2.2, 95% CI 1.1 to 4.4) and GMFM-66 (mean between-group difference=2.8 points, 95% CI 0.2 to 5.4) at 6 months, but not at 12 months. There was a trend for a small, but clinically irrelevant, improvement in the children's attitudes towards the disadvantages of sports at 6 months, and towards the advantages of sports at 12 months. Conclusions: This physical activity stimulation program, that combined fitness training, counselling and home-based therapy, was not effective in children with cerebral palsy. Further research should examine the potential of each component of the intervention for improving physical activity in this population. Trial registration: NTR2099. [Van Wely L, Balemans ACJ, Becher JG, Dallmeijer AJ (2014) Physical activity stimulation program for children with cerebral palsy did not improve physical activity: a randomised trial. Journal of Physiotherapy 60: 40–49

Measuring wearing time of knee-ankle-foot orthoses in children with cerebral palsy: comparison of parent-report and objective measurement

Purpose State Orthotic wearing time may be an important confounder in efficacy studies of treatment in children with spastic cerebral palsy (SCP). Most studies measure parent-reported wearing time with questionnaires, but it is questionable whether this yields valid results. This study aims to compare parent-reported wearing time (WTparent) with objectively measured wearing time (WTobj) in children with SCP receiving orthotic treatment. Method Eight children with SCP participated in this observational study. For one year, they received knee-ankle-foot orthosis (KAFO) treatment. WTparent was measured using questionnaires. WTobj was measured using temperature sensor-data-loggers that were attached to the KAFOs. The 2.5th and 97.5th percentiles and median of differences between methods (per participant) were used to calculate limits of agreement and systematic differences. Results There was no systematic difference between WTparent and WTobj (0.1 hours per week), but high inter-individual variation of the difference was found, as reflected by large limits of agreement (lower limit/2.5th percentile: -1.7. hours/week; upper limit/97.5th percentile: 11.1 hours/week). Conclusions Parent-reported wearing time of a knee-ankle-foot orthosis differs largely from objectively measured wearing time using temperature sensors. Therefore, parent-reported wearing time of KAFOs should be interpreted with utmost care

Sppl Forms a Membrane Protein Complex with SppA and Inhibits Its Protease Activity in Bacillus subtilis

The membrane protease SppA of Bacillus subtilis was first described as a signal peptide peptidase and later shown to confer resistance to lantibiotics. Here, we report that SppA forms octameric complexes with YteJ, a membrane protein of thus-far-unknown function. Interestingly, sppA and yid deletion mutants exhibited no protein secretion defects. However, these mutant strains differed significantly in their resistance to antimicrobial peptides. In particular, sppA mutant cells displayed increased sensitivity to the lantibiotics nisin and subtilin and the human lysozyme-derived cationic antimicrobial peptide LP9. Importantly, YteJ was shown to antagonize SppA activity both in vivo and in vitro, and this SppA-inhibitory activity involved the C-terminal domain of YteJ, which was therefore renamed Sppl. Most likely, Sppl-mediated control is needed to protect B. subtilis against the potentially detrimental protease activity of SppA since a mutant overexpressing sppA by itself displayed defects in cell division. Altogether, we conclude that the SppA-Sppl complex of B. subtills has a major role in protection against antimicrobial peptides. IMPORTANCE Our study presents new insights into the molecular mechanism that regulates the activity of SppA, a widely conserved bacterial membrane protease. We show that the membrane proteins SppA and Sppl form a complex in the Gram-positive model bacterium B. subtilis and that Sppl inhibits SppA protease activity in vitro and in vivo. Furthermore, we demonstrate that the C-terminal domain of Sppl is involved in SppA inhibition. Since SppA, through its protease activity, contributes directly to resistance to lantibiotic peptides and cationic antibacterial peptides, we propose that the conserved SppA-Sppl complex could play a major role in the evasion of bactericidal peptides, including those produced as part of human innate immune defenses

Intramuscular botulinum toxin prior to comprehensive rehabilitation has no added value for improving motor impairments, gait kinematics and goal attainment in walking children with spastic cerebral palsy

Objective: Botulinum toxin (BoNT-A) is widely used in combined treatment for spastic cerebral palsy, but its added value preceding comprehensive rehabilitation for motor impairments, gait, and goal attainment has not been studied. Design: A comparative multi-centre trial, in which two groups underwent comprehensive rehabilitation (i.e. high-intensive functional physiotherapy, and indicated casting/orthoses). One group received intramuscular BoNT-A prior to rehabilitation, and the other group did not receive BoNT-A. Subjects/patients: Children with spastic cerebral palsy, Gross Motor Function Classification System (GMFCS) levels I–III, age range 4–12 years, indicated for BoNT-A treatment regarding mobility problems. Methods: Sixty-five children participated (37 boys), mean age 7.3 years (standard deviation (SD) 2.3, range 4–12 years), equally distributed across GMFCS levels. Forty-one children received BoNT-A+ comprehensive rehabilitation and 24 received comprehensive rehabilitation only. Functional leg muscle strength, passive range of motion, angle of catch, cer

Splint: the efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration Number</p> <p>Nederlands Trial Register <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2091">NTR2091</a></p

Lower limb strength training in children with cerebral palsy – a randomized controlled trial protocol for functional strength training based on progressive resistance exercise principles

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p> <p>Trial Registration</p> <p>Trial Register NTR1403</p

LEARN 2 MOVE 7-12 years: a randomized controlled trial on the effects of a physical activity stimulation program in children with cerebral palsy

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>This study is registered in the Dutch Trial Register as NTR2099.</p

Reproducibility evaluation of gross and net walking efficiency in children with cerebral palsy

In evaluating energy cost (EC) of walking, referred to as walking efficiency, the use of net measurement protocols (i.e. net=gross-resting) has recently been recommended. However, nothing is known about the comparative reproducibility of net protocols and the commonly used gross protocols. Ten minutes of resting and 5 minutes of walking at a self-selected speed were used to determine gross and net EC in 13 children with spastic cerebral palsy (CP; seven males, six females; mean age 8y 7mo [SD 3y 4mo], range 4y 1mo-13y) and in 10 children (three males, seven females) with typical development. In the former, their Gross Motor Function Classification System levels ranged from Level I to Level III; and seven had hemiplegia and six diplegia. There were four repeated sessions on different days, with periods of 1 week between sessions. Reproducibility was assessed for speed, and gross and net EC, by using the standard error of measurement. The results of this preliminary study showed that EC measurements were more variable for children with CP than for children with typical development. Furthermore, in both groups there was considerably more variability in the net measurements than in the gross measurements. We conclude that, on the basis of the methodology used, the use of gross EC, rather than net EC, seems a more sensitive measure of walking efficiency to detect clinically relevant changes in an individual child with C