Objective: To perform an evidence-based review of the safety and efficacy of botulinum neurotoxin (BoNT) in the treatment of movement disorders. Methods: A literature search was performed including MEDLINE and Current Contents for therapeutic articles relevant to BoNT and selected movement disorders. Authors reviewed, abstracted, and classified articles based on American Academy of Neurology criteria (Class I–IV). Results: The highest quality literature available for the respective indications was as follows: blepharospasm (two Class II studies); hemifacial spasm (one Class II and one Class III study); cervical dystonia (seven Class I studies); focal upper extremity dystonia (one Class I and three Class II studies); focal lower extremity dystonia (one Class II study); laryngeal dystonia (one Class I study); motor tics (one Class II study); and upper extremity essential tremor (two Class II studies). Recommendations: Botulinum neurotoxin should be offered as a treatment option for the treatment of cervical dystonia (Level A), may be offered for blepharospasm, focal upper extremity dystonia, adductor laryngeal dystonia, and upper extremity essential tremor (Level B), and may be considered for hemifacial spasm, focal lower limb dystonia, and motor tics (Level C). While clinicians’ practice may suggest stronger recommendations in some of these indications, evidencebased conclusions are limited by the availability of data. Neurology ® 2008;70:1699–1706

https://n.neurology.org/content/neurology/70/19/1691.full.pdf

Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review) Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology

Brand's four reasons for clinical tests and his analysis of the characteristics of valid biomechanical tests for use in orthopaedics are taken as a basis for determining what methodologies are required for gait analysis in a clinical rehabilitation context. The state of the art of optical systems capable of measuring the positions of retro-reflective markers placed on the skin is sufficiently advanced that they are probably no longer a significant source of error in clinical gait analysis. Determining the anthropometry of the subject and compensating for soft tissue movement in relation to the under-lying bones are now the principal problems. Techniques for using functional tests to determine joint centres and axes of rotation are starting to be used successfully. Probably the last great challenge for optical systems is in using computational techniques to compensate for soft tissue measurements. In the long term future it is possible that direct imaging of bones and joints in three dimensions (using MRI or fluoroscopy) may replace marker based systems. There is still not an accepted general theory of why we walk the way we do. In the absence of this, many explanations of walking address the mechanisms by which specific movements are achieved by particular muscles. A whole new methodology is developing to determine the functions of individual muscles. This needs further development and validation. A particular requirement is for subject specific models incorporating 3-dimensional imaging data of the musculo-skeletal anatomy with kinematic and kinetic data. Clinical gait analysis is extremely limited if it does not allow clinicians to choose between alternative possible interventions or to predict outcomes. This can be achieved either by rigorously planned clinical trials or using theoretical models. The evidence base is generally poor partly because of the limited number of prospective clinical trials that have been completed and more such studies are essential. Very recent work has started to show the potential of using models of the mechanisms by which people with pathology walk in order to simulate different potential interventions. The development of these models offers considerable promise for new clinical applications of gait analysis.

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Gait analysis methods in rehabilitation.

The presentation of cerebral palsy can be global mental and physical dysfunction or isolated disturbances in gait, cognition, growth, or sensation. It is the most common childhood physical disability and affects 2 to 2.5 children per 1,000 born in the United States. The differential diagnosis of cerebral palsy includes metabolic and genetic disorders. The goals of treatment are to improve functionality and capabilities toward independence. Multispecialty treatment teams should be developed around the needs of each patient to provide continuously updated global treatment care plans. Complications of cerebral palsy include spasticity and contractures; feeding difficulties; drooling; communication difficulties; osteopenia; osteoporosis; fractures; pain; and functional gastrointestinal abnormalities contributing to bowel obstruction, vomiting, and constipation. Valid and reliable assessment tools to establish baseline functions and monitor developmental gains have contributed to an increasing body of evidenced-based recommendations for cerebral palsy. Many of the historical treatments for this ailment are being challenged, and several new treatment modalities are available. Adult morbidity and mortality from ischemic heart disease, cerebrovascular disease, cancer, and trauma are higher in patients with cerebral palsy than in the general population.

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Cerebral palsy: an overview.

Botulinum toxin, the most potent biological toxin, has become a powerful therapeutic tool for a growing number of clinical applications. This review draws attention to new findings about the mechanism of action of botulinum toxin and briefly reviews some of its most frequent uses, focusing on evidence based data. Double blind, placebo controlled studies, as well as open label clinical trials, provide evidence that, when appropriate targets and doses are selected, botulinum toxin temporarily ameliorates disorders associated with excessive muscle contraction or autonomic dysfunction. When injected not more often than every three months, the risk of blocking antibodies is slight. Long term experience with this agent suggests that it is an effective and safe treatment not only for approved indications but also for an increasing number of off-label indications.

https://jnnp.bmj.com/content/jnnp/75/7/951.full.pdf

Botulinum toxin in clinical practice.

The updated European Consensus 2009 on the use of Botulinum toxin for children with cerebral palsy

This study evaluated the efficacy and safety of three doses of botulinum toxin A (BTX-A; Dysport) in 125 patients (mean age 5.2 years, SD 2; 54% male)with dynamic equinus spasticity during walking. Participants were randomized to receive Dysport (10, 20, or 30 units/kg) or placebo to the gastrocnemius muscle of both legs. Muscle length was calculated from electrogoniometric measurements and the change in the dynamic component of gastrocnemius shortening at four weeks was prospectively identified as the primary outcome measure. All treatment groups showed statistically significant decreases in dynamic component compared with placebo at 4 weeks. Mean improvement in dynamic component was most pronounced in the 20 units/kg group, being equivalent to an increase in dorsiflexion with the knee extended at 19 degrees, and was still present at 16 weeks. The safety profile of the toxin appears satisfactory.

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J Wendorff

Papers

Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double-blind, placebo-controlled, dose-ranging study.