Abstract
BackgroundCerebral 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/DesignAn 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.DiscussionThis 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 registrationACTRN12611000454976
Highlights
Cerebral palsy is the most common cause of physical disability in childhood
In 2013, the Australian Cerebral Palsy Register reported that 71% of children with Cerebral palsy (CP) achieved ambulation and 91% were classified with spasticity as the predominant motor type
This study reported no improvement in either group for gross motor ability (GMFM-66), walking ability (One Minute Fast Walk Test) or participation (CAPE)
Summary
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. 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. Cerebral palsy (CP) is the most common cause of physical disability in childhood with an incidence of 2.11 per 1000 live births [1] It describes a “group of permanent disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain” [2]. Children with lower limb spasticity often experience a range of impairments including weakness, tightness, reduced motor control and muscle selectivity. These impairments can lead to limitations in functional ability, balance, ambulation and fitness compared to typically developing peers [3,4]. Physiotherapy intervention focuses on reducing these impairments and optimising functional, goal-related performance
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