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Functional outcomes of intramuscular Botulinum toxin type a and occupational therapy in the upper limbs of children with cerebral palsy: a randomized controlled trial |
Wallen M, O'Flaherty SJ, Waugh MC |
Archives of Physical Medicine and Rehabilitation 2007 Jan;88(1):1-10 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To investigate the functional outcomes of Botulinum toxin type A (BTX-A) injections to the upper limb in combination with occupational therapy (OT) in children with cerebral palsy (CP). DESIGN: Randomized controlled trial with follow-up at 2 weeks, 3 months, and 6 months. SETTING: Specialist outpatient physical disabilities clinic within a public pediatric teaching hospital. PARTICIPANTS: Eighty children with spastic quadriplegic, triplegic, or hemiplegic CP from these clinics were randomly assigned to BTX-A plus OT, BTX-A alone, OT alone, or a no-treatment control group. INTERVENTIONS: Single set of BTX-A (Botox) injections and 12 weeks of OT. MAIN OUTCOME MEASURES: Canadian Occupational Performance Measure (COPM) and Goal Attainment Scale (GAS). RESULTS: The combination of BTX-A and OT resulted in accelerated attainment of functional goals measured by the COPM and GAS. There were no differences between groups on the Melbourne Assessment of Unilateral Upper Limb Function, Quality of Upper Extremity Skills Test, Pediatric Evaluation of Disability Inventory, Child Health Questionnaire, or active and passive range of motion. As expected, there was a significant reduction in muscle tone at follow-up 2 weeks after injection, which returned to baseline level by 6 months. CONCLUSIONS: OT enhanced individualized functional outcomes following BTX-A injections in the upper limbs of children with CP.
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