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Open Access Study protocol

GRIN: “GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: an assessor-masked randomised comparison trial”: study protocol

Rachel E Thomas1*, Leanne M Johnston23, Roslyn N Boyd4, Leanne Sakzewski4 and Megan J Kentish1

Author Affiliations

1 Queensland Cerebral Palsy Health Service, The Royal Children’s Hospital, Brisbane, Australia

2 Cerebral Palsy League, Brisbane, Australia

3 School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia

4 Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, Brisbane, Australia

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BMC Pediatrics 2014, 14:35  doi:10.1186/1471-2431-14-35

Published: 7 February 2014

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

Keywords:
Botulinum Toxin-A; Cerebral palsy; Group physiotherapy; Models of training; Physiotherapy; Rehabilitation; Assessor-masked randomised comparison trial