Abstract | BACKGROUND:
Cerebral palsy is the most common cause of physical disability in childhood. Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation. The most common lower limb spasticity management is focal intramuscular injections of Botulinum Toxin-Type A accompanied by individually-delivered (one on one) physiotherapy rehabilitation. With increasing emphasis on improving goal-directed functional activity and participation within a family-centred framework, it is timely to explore whether physiotherapy provided in a group could achieve comparable outcomes, encouraging providers to offer flexible models of physiotherapy delivery. This study aims to compare individual to group-based physiotherapy following intramuscular Botulinum Toxin-A injections to the lower limbs for ambulant children with cerebral palsy aged four to fourteen years. METHODS/DESIGN: An assessor-masked, block randomised comparison trial will be conducted with random allocation to either group-based or individual physiotherapy. A sample size of 30 (15 in each study arm) will be recruited. Both groups will receive six hours of direct therapy following Botulinum Toxin-A injections in either an individual or group format with additional home programme activities (three exercises to be performed three times a week). Study groups will be compared at baseline (T1), then at 10 weeks (T2, efficacy) and 26 weeks (T3, retention) post Botulinum Toxin-A injections. Primary outcomes will be caregiver/s perception of and satisfaction with their child's occupational performance goals (Canadian Occupational Performance Measure) and quality of gait (Edinburgh Visual Gait Score) with a range of secondary outcomes across domains of the International Classification of Disability, Functioning and Health. DISCUSSION: This paper outlines the study protocol including theoretical basis, study hypotheses and outcome measures for this assessor-masked, randomised comparison trial comparing group versus individual models of physiotherapy following intramuscular injections of Botulinum Toxin-A to the lower limbs for ambulant children with cerebral palsy. TRIAL REGISTRATION: ACTRN12611000454976.
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Authors | Rachel E Thomas, Leanne M Johnston, Roslyn N Boyd, Leanne Sakzewski, Megan J Kentish |
Journal | BMC pediatrics
(BMC Pediatr)
Vol. 14
Pg. 35
(Feb 07 2014)
ISSN: 1471-2431 [Electronic] England |
PMID | 24502231
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Neuromuscular Agents
- Botulinum Toxins, Type A
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Topics |
- Adolescent
- Botulinum Toxins, Type A
(administration & dosage)
- Cerebral Palsy
(therapy)
- Child
- Child, Preschool
- Combined Modality Therapy
- Female
- Humans
- Injections, Intramuscular
- Lower Extremity
- Male
- Neuromuscular Agents
(administration & dosage)
- Physical Therapy Modalities
- Single-Blind Method
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