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

Thomas, Rachel E., Johnston, Leanne M., Boyd, Roslyn N., Sakzewski, Leanne and Kentish, Megan J. (2014) 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. BMC Pediatrics, 14 1: 35.1-35.13. doi:10.1186/1471-2431-14-35


Author Thomas, Rachel E.
Johnston, Leanne M.
Boyd, Roslyn N.
Sakzewski, Leanne
Kentish, Megan J.
Title 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
Journal name BMC Pediatrics   Check publisher's open access policy
ISSN 1471-2431
Publication date 2014-02-07
Year available 2014
Sub-type Article (original research)
DOI 10.1186/1471-2431-14-35
Open Access Status DOI
Volume 14
Issue 1
Start page 35.1
End page 35.13
Total pages 13
Place of publication London, United Kingdom
Publisher BioMed Central Ltd.
Collection year 2014
Language eng
Subject 2735 Pediatrics, Perinatology, and Child Health
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.
Keyword Assessor masked randomised comparison trial
Botulinum toxin A
Cerebral palsy
Group physiotherapy
Models of training
Physiotherapy
Rehabilitation
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Health and Rehabilitation Sciences Publications
School of Medicine Publications
 
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