Functional outcomes of intramuscular botulinum toxin type A in the upper limbs of children with cerebral palsy: a phase II trial.
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Arch Phys Med Rehabil 85 (2): 192--200 (February 2004)

OBJECTIVE: To describe the functional and family-centered assessment protocol and outcomes of a phase II trial evaluating upper-limb function after botulinum toxin injections in children with cerebral palsy (CP). DESIGN: Intervention study, case series, phase II trial, follow-up at 2 weeks and 3 and 6 months. SETTING: Specialist outpatient physical disabilities clinic within a public pediatric teaching hospital. PARTICIPANTS: Convenience sample of 16 children with CP (age range, 2-12y). INTERVENTIONS: Botulinum toxin type A (Botox) injections after electrical stimulation localization of appropriate muscle. MAIN OUTCOME MEASURES: The Canadian Occupational Performance Measure (COPM), Goal Attainment Scale (GAS), Melbourne Assessment of Unilateral Upper Limb Function, Child Health Questionnaire (CHQ), parent questionnaire, Modified Ashworth Scale (MAS), Tardieu scale, and active (AROM) and passive (PROM) range of motion. RESULTS: On the COPM, there was significant improvement at 3 months and 6 months. On the GAS, the T-scores were 42 and 47 at 3 and 6 months, respectively. On the Melbourne Assessment and CHQ, there was no significant change. The parent questionnaire indicated acceptability of injections and positive outcomes. On the MAS, there was a significant reduction in tone at 2 weeks, with a return to baseline by 6 months. On the Tardieu scale, there was a significant increase in angle of first catch at 2 weeks, but only the elbow maintained a significant difference at 3 and 6 months. No significant change was found for AROM or PROM. CONCLUSIONS: Sustained functional outcomes occurred after botulinum toxin injections despite increasing muscle tone after an initial reduction in tone. Randomized controlled trials are required.
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