Protocol for The Toxin Study: Understanding clinical and patient reported response of children and young people with cerebral palsy to intramuscular lower limb Botulinum neurotoxin-A injections, exploring all domains of the ICF. A pragmatic longitudinal observational study using a prospective one-group repeated measures design

INTRODUCTION: Botulinum neurotoxin-A (BoNT-A) is an accepted treatment modality for the management of hypertonia in children and young people with cerebral palsy (CYPwCP). Nevertheless, there are concerns about the long-term effects of BoNT-A, with a lack of consensus regarding the most meaningful outcome measures to guide its use. Most evidence to date is based on short-term outcomes, related to changes at impairment level (restrictions of body functions and structures), rather than changes in adaptive skills (enabling both activity and participation). The proposed study aims to evaluate clinical and patient reported outcomes in ambulant CYPwCP receiving lower limb BoNT-A injections over a 12-month period within all domains of the WHO's International Classification of Functioning, Disability and Health and health-related quality of life (HRQoL). METHODS AND ANALYSIS: This pragmatic prospective longitudinal observational study will use a one-group repeated measures design. Sixty CYPwCP, classified as Gross Motor Function Classification System (GMFCS) levels I-III, aged between 4 and 18 years, will be recruited from an established movement disorder service in London, UK. Standardised clinical and patient reported outcome measures within all ICF domains; body structures and function, activity (including quality of movement), goal attainment, participation and HRQoL, will be collected preinjection and at 6 weeks, 6 months and up to 12 months postinjection. A representative subgroup of children and carers will participate in a qualitative component of the study, exploring how their experience of BoNT-A treatment relates to clinical outcome measures. ETHICS AND DISSEMINATION: Central London Research Ethics Committee has granted ethics approval (#IRAS 211617 #REC 17/LO/0579). Findings will be disseminated in peer-reviewed publications, conferences and via networks to participants and relevant stakeholders using a variety of accessible formats including social media

Protocol for The Toxin Study: Understanding clinical and patient reported response of children and young people with cerebral palsy to intramuscular lower limb Botulinum neurotoxin-A injections, exploring all domains of the ICF. A pragmatic longitudinal observational study using a prospective one-group repeated measures design

This is the final version. Available from BMJ Publishing Group via the DOI in this record. Introduction: Botulinum neurotoxin-A (BoNT-A) is an accepted treatment modality for the management of hypertonia in children and young people with cerebral palsy (CYPwCP). Nevertheless, there are concerns about the long-term effects of BoNT-A, with a lack of consensus regarding the most meaningful outcome measures to guide its use. Most evidence to date is based on short-term outcomes, related to changes at impairment level (restrictions of body functions and structures), rather than changes in adaptive skills (enabling both activity and participation). The proposed study aims to evaluate clinical and patient reported outcomes in ambulant CYPwCP receiving lower limb BoNT-A injections over a 12-month period within all domains of the WHO’s International Classification of Functioning, Disability and Health and health-related quality of life (HRQoL). Methods and analysis: This pragmatic prospective longitudinal observational study will use a one-group repeated measures design. Sixty CYPwCP, classified as Gross Motor Function Classification System (GMFCS) levels I–III, aged between 4 and 18 years, will be recruited from an established movement disorder service in London, UK. Standardised clinical and patient reported outcome measures within all ICF domains; body structures and function, activity (including quality of movement), goal attainment, participation and HRQoL, will be collected preinjection and at 6 weeks, 6 months and up to 12 months postinjection. A representative subgroup of children and carers will participate in a qualitative component of the study, exploring how their experience of BoNT-A treatment relates to clinical outcome measures. Ethics and dissemination: Central London Research Ethics Committee has granted ethics approval (#IRAS 211617 #REC 17/LO/0579). Findings will be disseminated in peer-reviewed publications, conferences and via networks to participants and relevant stakeholders using a variety of accessible formats including social media.National Institute for Health Research (NIHR

Normal patellofemoral kinematic patterns during daily activities in dogs

Background: Patellar abnormalities are a common cause of pain and lameness in dogs; however, in vivo the relative motion between the femur and patella in dogs is not well described. The objective of this study was to define normal in vivo sagittal plane patellofemoral kinematics in three axes of motion using non-invasive methods. We hypothesized patellofemoral alignment in the sagittal plane would tightly correlate with the femorotibial flexion angle. Six healthy dogs without orthopedic disease underwent computed tomography (CT) of their hind limbs to create 3-D models of the patella and femur. Normal stifle joint motion was captured via flat-panel imaging while each dog performed a series of routine activities, including sitting, walking, and trotting. The 3-D models of the patella and femur were digitally superimposed over the radiographic images with shape-matching software and the precise movement of the patella relative to the femur was calculated. Results: As the femorotibial joint flexed, the patellofemoral joint also flexed and the patella moved caudally and distally within the femoral trochlea during each activity. Patellar flexion and distal translation during walk and sit were linearly coupled with the femorotibial flexion angle. Offset was evident while trotting, where patella poses were significantly different between early and late swing phase (p ≤ 0.003). Patellar flexion ranged from 51 to 6° while trotting. The largest flexion angle (92°) occurred during sit. The patella traversed the entire proximodistal length of the femoral trochlea during these daily activities. Conclusions: Using single-plane flat-panel imaging, we demonstrated normal in vivo patellofemoral kinematics is tightly coupled with femorotibial kinematics; however, trot kinematic patterns did not follow the path defined by walking and stand-to-sit motions. Our normal data can be used in future studies to help define patellofemoral joint kinematics in dogs with stifle abnormalities