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1.
Management of children with cerebral palsy (CP) is the focus of considerable resources in many countries, so that evaluation of the efficacy for new and established treatments is imperative. Botulinum toxin type A (BTX-A) is a relatively new method of spasticity management in children with cerebral palsy. It has been the focus of extensive research since its application to cerebral palsy 10 years ago. In a systematic review relating to the management of the lower limb in cerebral palsy 156 papers were identified. These were categorized according to Sackett and the World Health Organisation International Classification of Impairments, Disabilities and Handicaps model. We identified 10 randomized trials evaluating the use of BTX-A in the lower limb in children with cerebral palsy in a systematic review. A meta-analysis showed the pooled risk difference between BTX-A and placebo in three trials was 0.25 (95% CI 0.13, 0.37) and 0.23 (95% CI −0.06, 0.53) for two trials of BTX-A and casting using the physicians rating scale. These represent moderate treatment effects that are dosage-dependent. Outcomes were also compared for function in five studies. The type of evidence for BTX-A was graded by each treatment indication and directions for future research were then drawn from the available evidence.  相似文献   

2.
Aim:  To investigate the corticomotor projection to the upper limb in children with hemiplegic cerebral palsy (CP) and the changes that occur with botulinum toxin (BTX)-A.
Methods:  The study design is a pilot prospective randomized trial. Twenty-two children with hemiplegic CP aged 7 years to 13 years 11 months were recruited. Treatment group (12) received one series of BTX-A injections into the upper limb. Control group (10) did not receive upper limb BTX-A. All participants except one treatment group participant also received lower limb BTX-A. Transcranial magnetic stimulation (TMS) was performed at baseline, and 1, 3 and 6 months post-injection. Outcome measures were: change in position of affected and unaffected side first dorsal interosseous optimal site of stimulation (OPTx).
Results:  A shift in affected and unaffected side OPTx was observed for both treatment and control groups, and there was no statistically significant difference between groups at 1, 3 or 6 months. Poor tolerance of TMS cortical stimuli >80% was observed.
Conclusion:  Corticomotor projections associated with the upper limb in children with hemiplegic CP show significant variability over a 6-month period. This variability may reflect central motor reorganization because of systemic BTX-A effect or developmental changes. Upper limb BTX-A therapy is associated with reorganization of both affected and unaffected projections. Poor tolerance of the TMS procedure, in conjunction with higher cortical thresholds, may limit the usefulness of TMS as an investigatory tool in young children with movement disorders.  相似文献   

3.
Botulinum toxin type A (BTX-A) represents the gold standard therapy for focal spasticity after stroke, with low prevalence of complications, reversibility, and efficacy in reducing spastic hypertonia. Current guidelines suggest the employment of a dosage up to 600 units (U) of BTX-A to treat spasticity after stroke, to avoid important adverse effects and the development of antibodies against the neurotoxin. In recent years, NT 201, a new BTX-A free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity. In a prospective, non-randomized, open-label study, we studied the efficacy and safety of higher doses of BTX-A NT 201 (up to 840 U) in 25 consecutive patients with upper and lower limb spasticity after stroke, evaluated at 30 and 90 days after injections. Before and after the treatment, the grade of spasticity, the disability, and spasticity-related pain were extensively measured. After 30 days of follow-up, a great reduction of spasticity and pain with improvement of disability was observed. The effects were still present at 90 days of follow-up. No major adverse events were observed. Higher doses of BTX-A NT 201 appeared to be safe and efficacious in patients with upper and lower limb spasticity after stroke. However, further investigations are needed to determine its reproducibility in larger case series or randomized clinical trials and to observe the absence of antibodies against the neurotoxin also after repeated injections.  相似文献   

4.
The present study attempts to provide objective evidence of two treatment options for children with cerebral palsy (CP): multilevel botulinum toxin type A (BTX-A) injections and multilevel surgery. The purpose of the study was to clarify the differences and the similarities, and common treatment principles of both treatment strategies. Objective three dimensional gait analysis data were studied retrospectively in two patient groups pre- and post-treatment (randomly selected from a group of children that were treated between 1998 and 1999). In the first group, 29 children with CP were managed with BTX-A injections according to an integrated multilevel approach ( Molenaers et al ., 1999a ). A second group of 23 children with CP were managed by a more traditional single event multilevel surgery, also according to an integrated approach. Our aim was to evaluate the differences as well as the similarities between both patient groups, using a set of 56 parameters selected from three-dimensional gait analysis. The unifying concept between management with BTX-A injections and orthopaedic surgery was the adoption of a multilevel approach at one session. The groups demonstrated considerable differences with respect to age, pretreatment condition and amount and level of improvement after treatment. The children who received BTX-A were typically younger, and showed primary gait problems in the distal joints, whereas the children who underwent surgery demonstrated a higher frequency of gait deviations in the transverse plane and had more complications. Although the benefit of both treatments was confirmed by the present study, a difference in the amount and level of improvement was also demonstrated. In conclusion, these treatment modalities should be regarded as complementary rather than mutually exclusive treatments, with both calling for an integrated approach.  相似文献   

5.
The aim of this review was to assess the effectiveness of therapy interventions on improving outcomes in children with cerebral palsy (CP) who have received botulinum toxin A (BTX-A) injections to either upper or lower limb muscles. We searched: the Cochrane Central Register of Controlled Trials; the electronic databases Medline, EMBASE, CINAHL, PEDro, SCI, and SSCI; websites of professional associations; and reference lists in trial reports and other relevant articles. We used studies on the effect of therapy on motor control, functional abilities, contracture, spasticity, and/or pain as the selection criteria. Methodological quality and the strength of evidence was assessed systematically by three independent raters using American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) guidelines. Twenty-four papers met the criteria for inclusion in the content analysis of evidence. Of these, only one randomized controlled trial was available, with results demonstrating that electrical stimulation postinjection did not enhance the effects of BTX-A on gait improvement (insufficient data provided to report size of effect). Remaining papers were of level II evidence (n=2), Level IV evidence (n=5), and level V evidence (n=14). We conclude that there is insufficient evidence to either support or refute the use of therapy interventions after BTX-A injections in children with CP.  相似文献   

6.
Botulinum toxin type A (BoNT-A) therapy has gained wide acceptance in the management of spasticity in cerebral palsy (CP). Clinical experience from numerous case reports and series, retrospective and prospective open label cohort studies, and randomized controlled trials (RCT) has grown over the past 10 years. Several independent systematic reviews on the role of BoNT-A for upper and lower limb spasticity have been written by various authors. The objective of this paper is to summarize past systematic reviews and recent RCT not yet included in the systematic reviews that assess the effectiveness of BoNT-A in upper and lower limb spasticity in children with CP. We reviewed four Class II RCT discussed in five independent systematic reviews and two new Class II trials on the use of BoNT-A alone or with occupational therapy compared to placebo or occupational therapy alone in children with upper limb spasticity. There were 229 children recruited in these six trials and of those, 115 children received BoNT-A in the upper limbs. Five of six RCT showed a time limited decrease in muscle tone most especially at the wrist. Four of six trials showed improvement of hand function on a few specific functional tests. Four systematic reviews concluded that there is insufficient and inconsistent evidence to support or refute the effectiveness of BoNT-A in upper limb spasticity but one recent review recommended that BoNT-A should be considered as a treatment option in upper limb spasticity. For lower limb spasticity, we reviewed 13 RCT discussed in six systematic reviews and two new trials comparing BoNT-A with placebo or other rehabilitation modalities such as physiotherapy, occupational therapy, casting or electrical stimulation. In these studies, 617 children were recruited and of those, 360 children received BoNT-A in the lower limbs. There were six Class I and nine Class II trials. Three Class I trials documented significant improvement in gait pattern in children with gastrocnemius spasticity and one Class I study showed significant reduction in tone in the hip adductors. The most recent review establishes BoNT-A as an effective treatment for equinovarus deformity. Adverse events in these trials were mild and self-limited. The most common complaints were pain in the injection sites and transient weakness. BoNT-A is considered safe for use in children. In conclusion, there is now growing convincing evidence for the time limited beneficial effect of BoNT-A in decreasing muscle tone in children with upper and lower limbs spasticity associated with CP. Decrease muscle tone in the lower limbs translates to improved gait in CP children with spastic equinovarus however more systematic studies are necessary to show sufficient evidence for improved hand function from BoNT-A injection in the upper limbs.  相似文献   

7.
The purpose of this pilot study was to evaluate the effect of treatment with botulinum toxin A (BTX-A) injections on function in children with cerebral palsy (CP) using pedobarometric data collected in a standing position. Ten children with CP (seven males, three females) participated, five with diplegia and five with hemiplegia. All children exhibited signs of unilateral dynamic equinus foot disorder and were community ambulators. Age range at the time of treatment was 6 to 13 years (mean age 9 y, SD 2.5). A comprehensive clinical examination and a pedobarometric evaluation were performed before and after BTX-A injection. All children received at least one injection in each spastic muscle. BTX-A was given to eight children unilaterally and to two children bilaterally. A maximum dose of 4 to 8 units of BTX-A per kilogram body weight was administered. In comparison with pretreatment values, the pedobarometric evaluation revealed a significant increase in the whole plantar surface area on the affected side (p < 0.05), an increase in the peak pressure value at the hindfoot on the affected side (p < 0.05), and a significant shift in the body centre of mass to the affected limb (p < 0.05) 1 month after treatment with BTX-A. A significant decrease in the peak pressure value at the hindfoot on the unaffected side was also observed. Similarly, a decrease in the modified Ashworth scale and an increase in the range of motion were observed. Thus, BTX-A produces a significant plantar surface modification and a significant shift of the body centre of mass which represents an indirect measure of postural attitude. Pedobarometric evaluation can also be useful in quantifying clinical changes after treatment with BTX-A.  相似文献   

8.
The purpose of this study was to compare the cumulative efficacy (three treatment sessions) of botulinum toxin A (BTX-A) alone, casting alone, and the combination of BTX-A and casting in the management of dynamic equinus in ambulatory children with spastic cerebral palsy (CP). Thirty-nine children with spastic CP (mean age 5y 10mo, range 3 to 9y) were enrolled in the study. A multicenter, randomized, double blind, placebo-controlled prospective study was used. Children were randomly assigned to one of three treatment groups: BTX-A only (B), placebo injection plus casting (C), or BTX-A plus casting (B+C). The dosage for the BTX-A injections was 4U/kg per extremity. Assessments were performed at baseline, 3, 6, 7.5, and 12 months with a total of three treatments administered after the evaluations at baseline, 3, and 6 months. Primary outcome measures were ankle kinematics, velocity, and stride length. Secondary outcome measures were ankle spasticity, strength, range of motion, and ankle kinetics. Group B made no significant change in any variable at any time. Groups C and B+C demonstrated significant improvements in ankle kinematics, spasticity, passive range of motion, and dorsiflexor strength. Results of this 1-year study indicate that BTX-A alone provided no improvement in the parameters measured in this study, while casting and BTX-A/casting were effective in the short- and long-term management of dynamic equinus in children with spastic CP.  相似文献   

9.
The objective of this study was to determine whether the use of intramuscular botulinum toxin A (BTX-A) increases upper limb function and skills in the context of a specific therapy programme in children with hemiparetic cerebral palsy. Twenty children (nine females, 11 males) aged 4 to 16 years who were thought likely to benefit from BTX-A treatment were included. After matched pairs were made, on the basis of Zancolli grade and age, randomization took place. All patients were given structured rehabilitation (physiotherapy and occupational therapy three times a week for 6 months), and half of the patients received intramuscular BTX-A. No placebo injections were given in the control group. Participants were assessed at baseline, at 2 and 6 weeks, and at 3, 6, and 9 months after injection. The Ashworth scale, active range of motion of arm joints, the Melbourne assessment of upper limb function, the Pediatric Evaluation of Disability Inventory, and the nine-hole peg test were used for outcome measurement. Observers were blinded for treatment allocation only for scoring the Melbourne test. The children in the treatment group showed a clinically relevant increase in active dorsal flexion, and tone reduction of the wrist. For the functional outcome measures, no statistically significant differences between the groups could be demonstrated. Intramuscular BTX-A added to an intensive therapy programme reduces impairment for at least 9 months; the effect on activity level is still uncertain.  相似文献   

10.
The efficacy of repeated botulinum toxin A (BTX-A) injections in two and three dose regimes, together with occupational therapy, on upper limb movement and function, was studied using an evaluator blinded, randomized, controlled two-group trial. Forty-two children (31 males, 11 females; range 2-8 y, mean 4 y [SD 1 y 7 mo]) with hemiplegic cerebral palsy (Gross Motor Function Classification System Level I) longitudinally participated for 30 months, with the first 6 months reported earlier (Lowe et al. 2006). The BTX-A group (n=21) received three injections (0, 6, and 18 mo), while the delayed group had two (6 and 18 mo; dose 0.5-2.1 units/kg, mean 1.5 [SD 0.18]; dilution 100 units/0.5 ml). At 30 months, no difference existed between groups on any standardized measures. First and second injections showed significant treatment effect sizes, on Quality of Upper Extremity Skills Test (5.5 p=0.01: 4.5 p=0.03); parent Goal Attainment Scaling (GAS; 3.5 p=0.02: 3.9 p=0.01; therapist GAS 7.8 p=0.00: 4.0 p=0.03); Canadian Occupational Performance Measure (performance 0.4 p=0.05: 0.4 p=0.02; satisfaction 0.4 p=0.05: 0.37 p=0.08); and Pediatric Evaluation of Disability Inventory functional skills (1.8 p=0.00: 2.3 p=0.04). BTX-A was not linked to adverse events, suggesting repeated upper limb injections in children with hemiplegia receiving occupational therapy were safe and effective for improvement of movement and function.  相似文献   

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