PEDIATRICS Vol. 119 No. 5 May 2007, pp. e1149-e1158 (doi:10.1542/peds.2006-2425)
ARTICLE |
Upper-Limb Botulinum Toxin A Injection and Occupational Therapy in Children With Hemiplegic Cerebral Palsy Identified From a Population Register: A Single-Blind, Randomized, Controlled Trial
a Flinders University Department of Rehabilitation and Aged Care, Repatriation General Hospital, Daw Park, South Australia, Australia;
b Department of Child and Adolescent Development and Rehabilitation
f South Australian Clinical Genetics Service, Women's and Children's Hospital, North Adelaide, South Australia, Australia;
c Novita Children's Services, Regency Park, South Australia, Australia;
d Flinders Centre for Clinical Change and Health Care Research, Flinders University, Bedford Park, South Australia, Australia;
e Royal Hobart Hospital, Hobart, Tasmania, Australia
OBJECTIVES. The purpose of this work was to assess the effect of botulinum toxin A and occupational therapy compared with occupational therapy alone on body structure, activities participation, and self-perception in a sample of children (aged 3–16 years) with hemiplegic cerebral palsy recruited from a statewide register.
PATIENTS AND METHODS. Participants of this single-blind, randomized, controlled trial identified from a population-based cerebral palsy register received either an individually prescribed and localized injection of botulinum toxin A with 4 sessions of occupational therapy over 4 weeks (intervention) or occupational therapy alone (control). Outcomes were assessed from 2 domains of the World Health Organization International Classification of Functioning, Disability, and Health: body structure (Modified Ashworth Scale and Tardieu Scale) and activities participation (Assessment of Motor and Process Skills, Goal Attainment Scale, Pediatric Evaluation of Disability Inventory, and Pediatric Quality of Life Inventory). Self-perception was also measured.
RESULTS. All of the participants (intervention: n = 21; control: n = 22) provided data at baseline and 3 and 6 months. Mean age was 8.6 years; 23 were boys and 20 were girls. At 3 months, children allocated to receive the intervention performed significantly better in terms of body structure and activities participation. They reported improvements in self-perception for the global self-worth domain. At 6 months, the differences between the intervention and control groups persisted for the measures of body structure but not for activities participation or self-perception.
CONCLUSION. Botulinum toxin A injection combined with a low-intensity occupational therapy program achieves significant improvements in body structure, activity participation, and self-perception.
Key Words: botulinum toxin A • cerebral palsy • hemiplegia • child preschool • child • adolescent • disability evaluations • self-concept • randomized • controlled trial • upper extremity
Abbreviations: CP—cerebral palsy • BTX-A—botulinum toxin A • GAS—Goal Attainment Scaling • MAS—Modified Ashworth Scale • AMPS—Assessment of Motor and Process Skills • ADL—activities of daily living • PEDI—Pediatric Evaluation of Disability Inventory • PedsQL—Pediatric Quality of Life Inventory • SAE—serious adverse event • CI—confidence interval
Accepted Nov 1, 2006.
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