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

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

SPORTS STARS study protocol: a randomised, controlled trial of the effectiveness of a physiotherapist-led modified sport intervention for ambulant school-aged children with cerebral palsy

“…A random sequence will be generated via coin flip by an independent, off-site co-investigator (MA) who will not be involved with assessment or treatment (as per process used in previous studies [ 17 ]). The outcome (heads: group 1 = immediate Sports Stars intervention, group 2 = waitlist Sports Stars intervention.…”

“…Sport is one avenue to achieve this, and sports participation has been considered an alternative to prolonged physiotherapy intervention in adolescence and into adulthood [ 16 ]. By their nature, sport and physical activity interventions are more likely to occur in group formats, and children with CP who participate in group interventions have demonstrated increased engagement, motivation and participation compared to individual interventions [ 17 – 20 ] along with high levels of translation to real-world sports participation [ 21 , 22 ]. Additionally, compared to individual physiotherapy, group physiotherapy can be more cost effective in providing the same therapy dose [ 23 , 24 ].…”

How Does Botulinum Toxin Injection and Physiotherapy Complement Each Other in Cerebral Palsy?

“…BoNT/A injections in children with CP are generally combined with PT and OT, while trying to achieve better rehabilitation outcomes. This complementary application has been accepted generally because it can be applied to the spastic muscles directly and the amount of the toxin can be adjusted per muscle, and it has rapid effect and has only a few side effects [16,17]. But tone reduction alone is not enough for gaining functional outcomes.…”

“…Although the benefits of BoNT/A injections with PT and OT combinations are mentioned in many studies, optimal intensity and dosage of the therapies to be applied is not known [16]. According to expert opinion and consensus reports, PT following BoNT/A injections must consist of functional motor training, serial casting, stretching and strengthening exercises [26][27][28].…”

“…Appropriate selection of the patient, treatment dosage and muscles is crucial for effective injections [19]. In the scope of the International Classification and Functioning (ICF), BoNT/A injections affect body structures and functions; however, when it is combined with physiotherapy, it causes changes in the activity level as well [16]. The effectiveness of physiotherapy programs changes based on the application period and intensity [15].…”